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-ticker,disease,stage,date,catalyst
-ARWR,Alpha-1 Liver Disease,Phase 2,2023-06-24 00:00:00,"Phase 2 data presented at EASL showed that at week 48, patients receiving 25, 100, or 200 mg fazirsiran achieved serum Z-AAT reductions of 74%, 89%, and 94%, respectively, versus an increase of 9% observed in patients receiving placebo, noted June 24, 2023."
-AGIO,Sickle cell disease,Phase 2,2023-06-26 00:00:00,"Phase 2 portion met its primary endpoint of hemoglobin response for patients in both the 50 mg and 100 mg twice daily (BID) mitapivat arms, noted June 26, 2023"
-PHVS,Hereditary angioedema,Phase 1,2023-06-26 00:00:00,"Phase 1 clinical hold lifted by FDA on June 26, 2023."
-FGEN,Idiopathic pulmonary fibrosis,Phase 3,2023-06-26 00:00:00,"Phase 3 study did not meet primary endpoints, noted June 26, 2023."
-FGEN,Idiopathic pulmonary fibrosis (IPF),Phase 3,2023-06-26 00:00:00,"Phase 3 after ZEPHYRUS-1 results, company decided to discontinue this study, noted June 26, 2023."
-BNTC,Oculopharyngeal muscular dystrophy (OPMD),Phase 1/2,2023-06-26 00:00:00,"Phase 1b/2a IND clearance on June 26, 2023."
-AVTX,Non-Eosinophilic Asthma (NEA),Phase 2,2023-06-26 00:00:00,"Phase 2 did not meet the primary endpoint measured by reduction in asthma related events compared to placebo, noted June 26, 2023."
-FUSN,Solid tumors,Phase 1,2023-06-26 00:00:00,"Phase 1 pre-administration data reported a favorable gain in tumor lesion uptake versus normal tissue, noted June 14, 2022."
-CLVS,Ovarian Cancer - First-line maintenance treatment,PDUFA,2023-06-26 00:00:00,Company went bankrupt in 2022 not information disclosed about the PDUFA.
-ACET,Non-Hodgkin’s lymphoma,Phase 1,2023-06-26 00:00:00,"Phase 1 safety and efficacy data demonstrated 71% overall response rate (ORR) and 63% complete response (CR) rate across all dose levels in patients with median 4 prior lines of therapy, a Six-month CR rate consistent with autologous CAR T cell therapy, noted June 26, 2023."
-LLY,Obesity,Phase 2,2023-06-26 00:00:00,"Phase 2 24-week data met the primary endpoint for the efficacy estimand in participants living with obesity or overweight without diabetes, demonstrating a mean weight reduction up to 17.5%. In a secondary endpoint, retatrutide showed a mean weight reduction up to 24.2% at 48 weeks, noted June 26, 2023."
-TERN,Obesity,Phase 1a,2023-06-26 00:00:00,"Preclinical data demonstrated the ability of TERN-601 to significantly improve glucose tolerance, suppress food intake and slow gastric emptying in transgenic mice, noted June 26, 2023"
-EWTX,Becker muscular dystrophy (BMD),Phase 1b,2023-06-26 00:00:00,"Phase 1b 12-month study supported the hypothesis that a reduction in contraction-induced muscle damage in muscular dystrophies, associated with administration, has the potential to preserve and improve muscle function while preventing disease progression in dystrophinopathies, noted June 26, 2023."
-FUSN,Solid tumors,Phase 1,2023-06-26 00:00:00,"Phase 1 multi-dose safety and imaging data presented at SNMMI with Cold/Hot dosing regimen demonstrated potential to improve therapeutic index and safety profile, noted June 26, 2023."
-ALDX,Chronic Cough,Phase 2,2023-06-27 00:00:00,"Phase 2 trial demonstrated statistically significant reduction in cough frequency following administration of ADX‑629 relative to placebo, noted June 27, 2023."
-DRMA,Acne,Phase 2b,2023-06-27 00:00:00,"EoP2b FDA established key elements of the DMT310 Phase 3 clinical program and delineated a potential regulatory pathway for approval of DMT310, noted June 27, 2023."
-NKTX,Acute myeloid leukemia / myelodysplastic syndromes,Phase 1,2023-06-27 00:00:00,"Additional Phase 1 data demonstrated that 4 of 6 patients achieved complete response (67% CR/CRi, 50% CR rate), and 2 CRs with MRD negativity 1 patient deepened response to MRD negative CRi with additional cycles, notedJune 27, 2023."
-ETON,Methanol poisoning,CRL,2023-06-28 00:00:00,"CRL Announced on June 28, 2023."
-PFE,Children - growth hormone deficiency,Approved,2023-06-28 00:00:00,"FDA Approved on June 28, 2023."
-OPK,Children - growth hormone deficiency,Approved,2023-06-28 00:00:00,"FDA Approved on June 28, 2023."
-GMAB,Follicular lymphoma (FL),Phase 1/2,2023-06-28 00:00:00,"Phase 1/2 FL cohort data reported an overall response rate (ORR) of 82% and that the median duration of response (DOR) was not reached, noted June 28, 2023."
-ABBV,Follicular lymphoma (FL),Phase 1/2,2023-06-28 00:00:00,"Phase 1/2 FL cohort data reported an overall response rate (ORR) of 82% and that the median duration of response (DOR) was not reached, noted June 28, 2023."
-KPTI,Myelofibrosis (MF) - previously treated,Phase 3,2023-06-28 00:00:00,"Phase 3 dosing commenced, noted June 28, 2023."
-ALPMY,Severe vasomotor symptoms (VMS) due to menopause,Phase 3,2023-06-28 00:00:00,"Phase 3b data reported that the trial met its primary endpoint, noted June 28, 2023."
-AVXL,Rett syndrome,Phase 2,2023-06-28 00:00:00,"Phase 2 long-term clinical study results demonstrated disease modifying effect of ANAVEX2-73 (blarcamesine) for adult patients with Rett syndrome, noted June 28, 2023."
-RETA,Friedreich’s ataxia (FA),Approved,2023-06-28 00:00:00,"PAS approved June 28, 2023."
-CGTX,Mild-to-Moderate Alzheimer's Disease,Phase 2,2023-06-28 00:00:00,"Phase 2 study met its primary endpoints for safety and tolerability and showed positive effects for CT1812-treated participants as measured via quantitative electroencephalogram (qEEG), noted June 28, 2023."
-ALVO,Inflammatory diseases,CRL,2023-06-28 00:00:00,"Third CRL issued June 28, 2023. Resubmission planned."
-TEVA,Inflammatory diseases,CRL,2023-06-28 00:00:00,"Third CRL issued June 28, 2023. Resubmission planned."
-SLS,Malignant pleural mesothelioma (MPM),Phase 1,2023-06-28 00:00:00,"Phase 1 topline data reported that the median overall survival for patients who entered the study as Stage IV patients was 62.3 weeks, noted June 28, 2023."
-CLRB,Various lymphoma,Phase 2,2023-06-28 00:00:00,"Phase 2 data from MM cohort reported an overall response rate (ORR) of 32%, a clinical benefit rate (CBR) of 75% and a disease control rate (DCR) of 85.7%, noted June 28, 2023."
-BIIB,Friedreich’s ataxia (FA),Approved,2023-06-28 00:00:00,"PAS approved June 28, 2023."
-PTCT,Huntington's disease,Phase 2,2023-06-28 00:00:00,"Phase 2 trial initiated March 30, 2022. Phase 2 trial data reported that treatment was well tolerated, with no treatment related serious adverse events and no adverse events leading to discontinuation, noted June 28, 2023."
-EIGR,Chronic hepatitis delta virus (HDV),Phase 3,2023-06-29 00:00:00,"Phase 3 data presented at EASL showed that at week 48 the trial met its primary endpoint in both lonafarnib arms vs placebo, also 24-week post-treatment data demonstrated that both lonafarnib arms showed a statistically significant difference in composite response rate compared to placebo, noted June 24, 2023."
-PTCT,Mitochondrial Epilepsy,Phase 2/3,2023-06-29 00:00:00,"Phase 2/3 data reported that trial did not meet the primary endpoint, noted June 29, 2023."
-BMRN,Hemophilia A,Approved,2023-06-29 00:00:00,"Approved June 29, 2023."
-BHC,Dry Eye Disease Associated With Meibomian Gland Dysfunction,Approved,2023-06-29 00:00:00,"Approved on May 18, 2023."
-FBIO,Gout,Phase 1,2023-06-29 00:00:00,"Phase 1 study dosing commenced, noted May 31, 2022. Phase 1 data show edcomparable pharmacokinetic, pharmacodynamic and safety profile between U.S. and Japanese healthy subjects, noted Jue 29, 2023. Phase 1b clinical trial in gout patients in the U.S. and expect to begin pivotal clinical trials in 2024."
-RNXT,Locally advanced pancreatic cancer (LAPC),Phase 3,2023-06-29 00:00:00,"Phase 3 interim data presented at ESMO GI demonstrated an eight-month median PFS benefit, 15 versus 7 months, in delaying the progression of cancer for patients receiving treatment with RenovoGem versus standard-of-care, noted June 29, 2023."
-MNOV,Alcohol Use Disorder (AUD),Phase 2b,2023-06-29 00:00:00,"Phase 2b data reported that treatment was not superior to placebo, noted June 29, 2023."
-ALDX,Retinitis Pigmentosa,Phase 2,2023-06-29 00:00:00,"Phase 2 top-line results presented on a webcast demonstrated statistically significant improvement in retinal function across a number of different physiological and psychophysical assessments, June 29, 2023."
-BTAI,Agitation associated with Alzheimer’s Disease,Phase 3,2023-06-29 00:00:00,"Phase 3 topline data reported that only 60mcg dose met primary endpoint, with a 7.5 point reduction versus 5.4 point reduction in the placebo group, noted June 29, 2023."
-PSTV,Glioma,Phase 1/2,2023-06-29 00:00:00,"Phase 1/2 data presented at the Society of Nuclear Medicine & Molecular Imaging's (SNMMI) Annual Meeting demonstrated efficacy signals in a prognostically unfavorable patient population. The median overall survival (OS) in all 21 patients was 11 months or a 38% increase in OS versus a median OS of approximately 8 months for standard of care in rGBM. Median OS in patients receiving >100 Gy of absorbed radiation dose was 76 weeks versus 22 weeks for those receiving <100 Gy (p=0.0002), noted June 29, 2023."
-CANF,Psoriasis,Phase 3,2023-06-29 00:00:00,"Phase 3 top-line data reported that trial met primary endpoint, noted June 29, 2022. Additionally in their Phase 3 the FDA encouraged the Company to enroll adolescent patients due to the strong safety profile of the drug demonstrated over the development history and prior clinical studies, noted June 29, 2023"
-BLCO,Dry Eye Disease Associated With Meibomian Gland Dysfunction,Approved,2023-06-29 00:00:00,"Approved on May 18, 2023."
-CYT,"Hematologic malignancies, solid tumors, triple negative breast cancer",Phase 1,2023-06-30 00:00:00,"Phase 1 development discontinued due to dissolution, noted June 30, 2023."
-SRRK,Spinal muscular atrophy (SMA),Phase 2,2023-06-30 00:00:00,"Phase 2 36-month extension data presented at the Cure SMA Conference showed that continued treatment with apitegromab over the extended treatment period was associated with substantial and sustained improvement in motor function, noted June 30, 2023."
-IPSEY,Primary biliary cholangitis (PBC),Phase 3,2023-06-30 00:00:00,"Phase 3 data reported that trial met primary endpoint, noted June 30, 2023."
-GNFT,Primary biliary cholangitis (PBC),Phase 3,2023-06-30 00:00:00,"Phase 3 data reported that trial met primary endpoint, noted June 30, 2023."
-KRYS,Cystic Fibrosis,Phase 1,2023-07-03 00:00:00,"Phase 1 dosing commenced, noted July 3, 2023"
-AMRX,Parkinson's disease,CRL,2023-07-03 00:00:00,"CRL issued by the FDA on July 3, 2023."
-CCCC,Non-Small Cell Lung Cancer (NSCLC),Phase 1a,2023-07-05 00:00:00,"IND Cleared by FDA, July 5, 2023."
-PTGX,Plaque psoriasis,Phase 2b,2023-07-05 00:00:00,"Phase 2b trial met all primary and secondary efficacy endpoints, noted July 5, 2023."
-JNJ,Plaque psoriasis,Phase 2b,2023-07-05 00:00:00,"Phase 2b trial met all primary and secondary efficacy endpoints, noted July 5, 2023."
-MRNA,Respiratory syncytial virus (RSV) vaccine,BLA Filing,2023-07-05 00:00:00,"BLA rolling submission, noted July 5, 2023."
-ALLR,Metastatic breast cancer (mBC),Phase 2,2023-07-05 00:00:00,"Phase 2 intial data showed potential for improved clinical benefit in DRP-selected metastatic breast cancer patients, noted July 5, 2023."
-BIIB,Mild cognitive impairment (MCI) due to Alzheimer's disease (AD),Approved,2023-07-06 00:00:00,"Traditional approval received July 6, 2023."
-BDRX,Diffuse Midline Glioma (DMG),Phase 1,2023-07-06 00:00:00,"Phase 1 trial reported a median overall survival (OS) of 26.1 month, noted July 6, 2023."
-VXRT,Norovirus vaccine,Phase 2,2023-07-06 00:00:00,"Phase 2 topline data reported a similar increase in serum antibody responses with no statistical difference between the medium and high dose arms, and the candidate was well tolerated, noted July 6, 2023."
-CLDX,Eosinophilic esophagitis (EoE),Phase 2,2023-07-06 00:00:00,"Phase 2 dosing initiated, noted July 6, 2023."
-CRIS,Acute Myeloid Leukemia / Myelodysplastic Syndromes (MDS),Phase 1/2,2023-07-06 00:00:00,"FDA removed partial hold, noted July 6, 2023"
-KZIA,Brain Metastases,Phase 1,2023-07-06 00:00:00,"FDA awarded Fast Track Designation, noted July 6, 20223."
-GNLX,Malignant pleural effusion (MPE) due to non-small cell lung cancer (NSCLC) or breast cancer.,Phase 1,2023-07-10 00:00:00,"Phase 1 expansion data showed a median overall survival (OS) was 19.5 months. The median OS among patients who had malignant pleural mesothelioma (MPM) was 22 months.. There were no dose-limiting toxicities or dose de-escalations, and the maximally tolerated dose was not reached. Therefore, a recommended dose was not established, noted July 10, 2023."
-TNGX,Solid Tumors,Phase 1/2,2023-07-10 00:00:00,"Phase 1/2 dosing initiated, noted July 10, 2023."
-MDWD,Basal Cell Carcinoma (BCC),Phase 1/2,2023-07-10 00:00:00,"Phase 1/2 data reported that treatment was safe and well-tolerated with eleven out of fifteen patients achieved complete clearance of their BCCs, noted July 10, 2023."
-EXAI,Advanced Solid Tumors,Phase 1/2,2023-07-10 00:00:00,"Phase 1/2 first patient enrolled, noted July 10, 2023."
-VRDN,Active Thyroid Eye Disease (TED),Phase 1/2,2023-07-10 00:00:00,"Phase 1/2 preliminary data demonstrated clinically meaningful and rapid improvement in signs and symptoms of chronic TED at week 6 after receiving two infusions of VRDN-001 10 mg/kg or 3 mg/kg, noted July 10, 2023."
-BDRX,Children with Newly Diagnosed Diffuse Midline Gliomas (DMGs),Phase 1,2023-07-10 00:00:00,"Phase 1 enrollment completed, noted July 10, 2023."
-GOVX,Head and neck squamous cell carcinoma (HNSCC),Phase 1/2,2023-07-10 00:00:00,"Phase 1/2 study data presented at AHNS resulted on impairment of tumor growth (i.e., ""stable disease"" using RECIST 1.1 evaluation criteria) in targeted lesions was seen in 5 of 7 patients; tumor response assessment in one patient remains under study, noted July 10, 2023."
-IBRX,Acute myeloid leukemia (AML),Phase 1,2023-07-10 00:00:00,"Phase 1 results presented at the AHNS indicated the potential for a new treatment approach for the disease in advanced cases that currently have extremely poor prognoses, noted July 10, 2023."
-IOVA,anti-PD-1 therapy for advanced (unresectable or metastatic) Non-small Cell Lung Cancer (NSCLC),Phase 2,2023-07-10 00:00:00,"Phase 2 preliminary data in the trial showed that the median duration of response wasn't reached. Treatrdent-emergent adverse events were consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and interleukin-2, noted July 10, 2023."
-TNXP,Pediatric obesity related binge eating disorder,Phase 2,2023-07-10 00:00:00,"Phase 2 trial initiated, noted July 10, 2022."
-FBIO,Papulopustular Rosacea,Phase 3,2023-07-11 00:00:00,"Phase 3 topline data achieved the co-primary and all secondary endpoints and subjects completed the 16-week treatment with no significant safety issues, noted July 11, 2023."
-ADCT,High-Risk Relapsed/Refractory Follicular Lymphoma,Phase 2,2023-07-11 00:00:00,"Phase 2 trial enrollment voluntarily paused after recent review of aggregate data of the 40 patients enrolled in the trial and consultation with the Data Monitoring Committee (DMC) which signaled potentially excessive respiratory-related events, noted July 11, 2023."
-DERM,Papulopustular Rosacea,Phase 3,2023-07-11 00:00:00,"Phase 3 topline data achieved the co-primary and all secondary endpoints and subjects completed the 16-week treatment with no significant safety issues, noted July 11, 2023."
-SYBX,Phenylketonuria (PKU),Phase 1,2023-07-11 00:00:00,"FDA Granted Fast Track Designation on July 11, 2023."
-CLDX,Chronic spontaneous urticaria (CSU),Phase 2,2023-07-11 00:00:00,"Phase 2 data ahead of schedule, enrollment completed, noted July 11, 2023."
-DERM,Papulopustular rosacea,Phase 3,2023-07-11 00:00:00,Phase 3 topline data achieved the co-primary and all secondary endpoints and subjects completed the 16-week treatment with no significant safety issues. NDA filing due in 2H 2023.
-PULM,Acute migraine,Phase 1,2023-07-11 00:00:00,"IND submitted to FDA to initiate Phase 2 trial, noted July 11, 2023."
-CGTX,Geographic Atrophy Secondary to Dry Age-related Macular Degeneration (AMD),Phase 1,2023-07-11 00:00:00,"Phase 2 trial dosing initiated, noted July 11, 2023."
-ADIL,Alcohol use disorder,Phase 3,2023-07-11 00:00:00,"FDA reviewed the safety data from the ONWARD trial and did not express any concerns with the data, noted July 11, 2023."
-CRBU,B-Cell Non-Hodgkin Lymphoma,Phase 1,2023-07-13 00:00:00,"Phase 1 update reported a 94% overall response rate (ORR), 69% complete response (CR) rate, and 44% CR rate at ≥6 months following a single dose of CB-010, with 24 months as the longer CR maintained to date, noted July 13, 2023."
-FWBI,Exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP),Phase 2,2023-07-13 00:00:00,"Phase 2 topline Initial data from the study indicated the enhanced adrulipase formulation was safe and well tolerated and demonstrated an improvement over prior formulations of adrulipase. However, the preliminary data also indicate that it is likely the primary efficacy endpoint was not achieved, noted July13,. 2023."
-CALT,Squamous Cell Carcinoma of the Head and Neck (SCCHN),Phase 2,2023-07-13 00:00:00,"Phase 2 biomarker data reported that 7 out of the 16 evaluable patients were progression-free with either stable disease or partial response, out of which 6 were in the setanaxib arm and 1 was in the placebo arm, noted July 13, 2023."
-ZLAB,Gastric and gastro-esophageal junction cancer,Phase 3,2023-07-14 00:00:00,"Trial in China initiated, noted July 14, 2023."
-AMGN,Gastric and gastro-esophageal junction cancer,Phase 3,2023-07-14 00:00:00,"Trial in China initiated, noted July 14, 2023."
-GILD,Covid-19,Approved,2023-07-14 00:00:00,"Approved July 14, 2023."
-HALO,Chronic inflammatory demyelinating polyneuropathy (CIDP),Phase 2,2023-07-17 00:00:00,"Phase 2 trial met primary endpoints, noted July 17, 2023."
-ARGX,Chronic inflammatory demyelinating polyneuropathy,Phase 2,2023-07-17 00:00:00,Phase 2 top-line data met primary endpoint; VYVGART Hytrulo demonstrated 61% reduction in risk of relapse versus placebo
-HALO,Chronic inflammatory demyelinating polyneuropathy (CIDP),Phase 2,2023-07-17 00:00:00,"Phase 2 trial met primary endpoints, noted July 17, 2023."
-ARGX,Chronic inflammatory demyelinating polyneuropathy (CIDP),Phase 2,2023-07-17 00:00:00,"Phase 2 trial met primary endpoints, noted July 17, 2023."
-ZLAB,Chronic inflammatory demyelinating polyneuropathy (CIDP),Phase 2,2023-07-17 00:00:00,"Phase 2 trial met primary endpoints, noted July 17, 2023."
-VIRI,Long COVID-19,Phase 2,2023-07-17 00:00:00,"Phase 2 data reported clinically and statistically significant improvements in fatigue, pain, and symptoms of autonomic dysfunction, noted July 17, 2023."
-BPTH,Solid tumors,Phase 1,2023-07-17 00:00:00,"Phase 1/1b first cohort completed, noted July 17, 2023"
-VAXX,Parkinson's disease,Phase 1,2023-07-17 00:00:00,"Additional Phase 1 data reported that antibodies derived from UB-312, slowed the seeding of alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) of patients with PD as demonstrated using multiple target engagement assays, noted July 17, 2023."
-PRTA,Alzheimer’s disease,Phase 1,2023-07-17 00:00:00,"Phase 1 SAD data presented at AAIC met key pharmacokinetic (PK) and immunogenicity secondary endpoints, noted July 17, 2023"
-LLY,Alzheimer’s disease,Phase 3,2023-07-17 00:00:00,"Phase 3 data presented at AAIC reported a 60% slowing of decline compared to placebo with nearly half of participants at earlier stage of disease on donanemab had no clinical progression at 1 year, noted July 17, 2023."
-AZN,Respiratory syncytial virus,Approved,2023-07-17 00:00:00,"FDA Approved on July 17, 2023."
-KPTI,Myelofibrosis - naïve,Phase 2,2023-07-17 00:00:00,"FDA Granted Fast Track Designation on July 17, 2023."
-CORT,Nonalcoholic steatohepatitis (NASH),Phase 1b,2023-07-17 00:00:00,"Phase 1b data demonstrated that miricorilant effectively reduced liver fat, improved liver health and key metabolic and lipid measures and is well-tolerate, noted July 17, 2023."
-IMMX,Solid tumors,Phase 1/2,2023-07-17 00:00:00,"Phase 1b/2a additional data noted that tumor shrinkage was observed in 3 out of 4 (75%) patients; 1 out of 4 (25%) experienced tumor control as of the July 7, 2023 clinical data cutoff date. All patients had stage IV relapsed/refractory metastatic colorectal cancer and received 8 median lines of therapy prior to IMX-110 + tislelizumab, noted July 17, 2023."
-BLRX,Pancreatic ductal adenocarcinoma (PDAC),Phase 2,2023-07-17 00:00:00,"Phase 2b trial initiated, noted July 17, 2023."
-JANX,Metastatic castration-resistant prostate cancer (mCPRC),Phase 1,2023-07-17 00:00:00,"Phase 1 interim clinical data showed tumor-activated T cell engagement in patients with prostate cancer representing the first-in-human data for the TRACTr platform and providing confidence for continuing clinical development of JANX007 and advancing future programs from the platform, noted July 17, 2023."
-ACIU,Neurodegenerative diseases (NDD),Phase 1,2023-07-18 00:00:00,"Updated biomarker data reported that ACI-15916shows significantly improved specific binding to pathological a-syn aggregates in brain sections from different a-synucleinopathy cases, noted July 18, 2023."
-LGND,Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS),Phase 1b,2023-07-18 00:00:00,"Phase 1b expansion trial data reported that one patient remained on study with sustained complete response for 8 cycles, noted July 18, 2023."
-APVO,Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS),Phase 1b,2023-07-18 00:00:00,"Phase 1b expansion trial data reported that one patient remained on study with sustained complete response for 8 cycles, noted July 18, 2023."
-MRK,Cervical cancer,Phase 3,2023-07-19 00:00:00,"Phase 3 data reported that trial met the PFS primary endpoint, noted July 19, 2023."
-SNPX,Multiple sclerosis (MS),Phase 1,2023-07-19 00:00:00,"IND submitted to FDA, noted July 19, 2023"
-PFE,Streptococcus Vaccine,Phase 2,2023-07-19 00:00:00,"Phase 2 results showed that the investigational vaccine, GBS6, was generally well-tolerated and generated robust maternal antibody responses that were efficiently transferred to infants, noted July 19, 2023."
-NBTX,Non-small cell lung cancer (NSCLC),Phase 1/2,2023-07-19 00:00:00,"Phase 1/2 dosing initiated, noted July 19, 2023."
-HRMY,Excessive daytime sleepiness associated with Prader-Willi Syndrome (PWS),Phase 2,2023-07-20 00:00:00,"EoP2 meeting completed, noted July 20, 2023"
-VIR,Influenza,Phase 2,2023-07-20 00:00:00,"Phase 2 trial did not meet its primary endpoint, noted July 20, 2023."
-MDNA,Recurrent Glioblastoma (GBM),Phase 2b,2023-07-20 00:00:00,"Phase 2b trial published in the journal Neuro-Oncology, and when compared to a well-matched external control, bizaxofusp more than doubled the median survival in end-stage rGBM patients, noted July 20, 2023. Phase 3 trial planned."
-FIXX,Phenylketonuria (PKU),Phase 1,2023-07-21 00:00:00,"Phase 1 initial data reported that participant 2 has experienced a meaningful plasma Phe reduction of 49% at 17, and participant 1 had a reduction in plasma phenylalanine (Phe) levels to below the ACMG PKU treatment guideline threshold of <360 μmol/L, noted July 27, 2023."
-GILD,Higher risk-Myelodysplastic Syndrome (MDS),Phase 3,2023-07-21 00:00:00,"Phase 3 ENHANCE study been discontinued due to futility based on a planned analysis, noted July 21, 2023."
-VRCA,Molluscum contagiosum,Approved,2023-07-21 00:00:00,"Approved July 21, 2023."
-PHVS,Hereditary angioedema - on demand,Phase 2,2023-07-21 00:00:00,"Phase 2 data reported that trial met primary and all key secondary endpoints, noted July 21, 2023."
-EBS,Anthrax Vaccine,Approved,2023-07-21 00:00:00,"Approved July 21, 2023."
-SNDX,Chronic Graft versus host disease (cGvHD),Phase 2,2023-07-24 00:00:00,"Phase 2 trial results met its primary endpoint across all cohorts with an overall response rate (ORR) of 74% at a dose of 0.3 mg/kg administered every two weeks, noted July 24, 2023."
-INCY,Chronic Graft versus host disease (cGvHD),Phase 2,2023-07-24 00:00:00,"Phase 2 trial results met its primary endpoint across all cohorts with an overall response rate (ORR) of 74% at a dose of 0.3 mg/kg administered every two weeks, noted July 24, 2023."
-KOD,Diabetic macular edema (DME),Phase 3,2023-07-24 00:00:00,"Phase 3 trial did not meet the primary endpoint, noted July 24, 2023."
-TNGX,Solid Tumors,Phase 1,2023-07-24 00:00:00,"IND cleared by FDA, noted April 3, 2023. Phase 1/2 dosing initiated, noted July 24, 2023."
-LCTX,Non-small cell lung cancer (NSCLC),Phase 1,2023-07-24 00:00:00,"Phase 1 data reported that five of eight patients treated (62.5%) had a best response of immune-related stable disease, and three (37.5%) demonstrated immune-related progressive disease, noted July 24, 2023."
-DYAI,COVID-19 booster vaccine,Phase 1,2023-07-24 00:00:00,"Phase 1 safety data reporter no Serious Adverse Events or Adverse Events of Special Interest have been reported to date, noted July 24, 2023"
-BMEA,Acute myeloid leukemia (AML) / acute lymphocytic leukemia (ALL) / Diffuse large B-cell lymphoma (DLBCL) / Multiple myeloma (MM),Phase 1,2023-07-24 00:00:00,"Phase 1 clinical update of AML cohort revealed 2 complete responses (CRs) out of 5 relapsed/refractory AML patients carrying menin-dependent mutations treated at Dose Level 4, noted July 24, 2023."
-PXMD,Human African Trypanosomiasis (HAT),Phase 2b,2023-07-24 00:00:00,"Phase 2b trial met its primary endpoint, noted July 24, 2023."
-LRMR,Friedreich’s ataxia (FA),Phase 2,2023-07-25 00:00:00,"FDA Phase 2 clearance for dose exploration trial and OLE trial, Initiation of open-label extension trial with 25 mg daily dosing expected in 1Q 2024, noted July 25, 2023. Phase 2 50mg cohort topline data expected 1H 2024. Phase 2 interim data expected 4Q 2024."
-TARS,Demodex Blepharitis,Approved,2023-07-25 00:00:00,"FDA approved on July 25, 2023."
-LIAN,Demodex Blepharitis,Approved,2023-07-25 00:00:00,"FDA approved on July 25, 2023."
-STOK,Dravet Syndrome,Phase 1/2,2023-07-25 00:00:00,"Phase 1/2 data presented showed that patients treated with 2 or 3 initial doses experienced substantial and sustained reductions in convulsive seizure frequency; Median reductions at 3 months after last dose of 80% and 89% at 6 months after last dose, compared to baseline, noted July 25, 2023."
-GOSS,Pulmonary arterial hypertension (PAH),Phase 2,2023-07-25 00:00:00,"Phase 2 OLE data reported that 9 of 11 patients continued to improve, with a mean improvement of 9 PVR dual responders of 39%, and 3 patients reached a PVR below 200 dyne*s/cm5n, noted July 25, 2023."
-STOK,Dravet Syndrome,Phase 1/2,2023-07-25 00:00:00,"Phase 1/2a new data suggest clinical benefit for patients 2 to 18 years of age treated with multiple doses of STK-001. The observed reductions in convulsive seizure frequency as well as substantial improvements in cognition and behavior support the potential for disease modification in a highly refractory patient population, noted July 25, 2024"
-STOK,Dravet syndrome,Phase 1/2,2023-07-25 00:00:00,"Phase 1/2a OLE OLE data of STK-001 (30mg, 45mg) showed a Sustained reductions in convulsive seizure frequency and improvements in cognition and behavior, noted July 25, 2023."
-KPTI,Endometrial cancer,Phase 3,2023-07-25 00:00:00,"Phase 3 updated exploratory subgroup analysis reported a median PFS of 27.4 months compared to 5.2 months for patients with TP53 wild-type endometrial cancer receiving placebo, noted July 25, 2023."
-STOK,Dravet syndrome,Phase 1/2,2023-07-25 00:00:00,"Additional Phase 1/2s safety data showed that it has been generally well-tolerated among 74 patients treated with single and multiple doses of 10mg to 70mg, noted July 25, 2023."
-ATHE,Multiple System Atrophy (MSA),Phase 2,2023-07-26 00:00:00,"Phase 2 trial recommended by DMC on July 26, 2023."
-LPCN,Liver cirrhosis,Phase 2,2023-07-27 00:00:00,"Phase 2 trial met its primary endpoint, noted July 27, 2023."
-LLY,Obesity or overweight with weight-related comorbidities,Phase 3,2023-07-27 00:00:00,"Phase 3 trial met both co-primary endpoints, noted July 27, 2023."
-LLY,Obesity or overweight with weight-related comorbidities,Phase 3,2023-07-27 00:00:00,"Phase 3 trial met primary endpoint, noted July 27, 2023."
-MRK,Pneumococcal conjugate vaccine,Phase 3,2023-07-27 00:00:00,"Phase 3 trial met primary endpoint, noted July 27, 2023."
-LGND,Pneumococcal conjugate vaccine,Phase 3,2023-07-27 00:00:00,"Phase 3 trial met primary endpoint, noted July 27, 2023."
-LGND,Pneumococcal Conjugate Vaccine,Phase 3,2023-07-27 00:00:00,"Phase 3 trial met primary endpoints, noted July 27, 2023."
-EYPT,Wet age-related macular degeneration (AMD),Phase 2,2023-07-27 00:00:00,"Phase 2 trial continued to demonstrate that EYP-1901 is well tolerated with no reported drug-related ocular or systemic SAEs, noted July 27, 2023."
-MRSN,"Ovarian Cancer, Non Small Cell Lung Cancer",Phase 1/2,2023-07-27 00:00:00,"Phase 1/2 trial did not meet its primary endpoint, noted July 27, 2023."
-MRK,Pneumococcal Conjugate Vaccine,Phase 3,2023-07-27 00:00:00,"Phase 3 trial met primary endpoints, noted July 27, 2023."
-URGN,Low grade non-muscle invasive bladder cancer (LG-NMIBC),Phase 3,2023-07-27 00:00:00,"Phase 3 trial met primary endpoint with 79.2% rate of complete response at 3-months following the initial treatment, noted July 27, 2023."
-URGN,Non-Muscle-Invasive Bladder Cancer,Phase 3,2023-07-27 00:00:00,"Phase 3 trial met primary endpoint, noted July 27, 2023."
-DTIL,Relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL),Phase 1/2,2023-07-27 00:00:00,"Phase 1/2 Type B End of Phase 1 meeting with the FDA provided clarity and direction to advance to Phase 2, noted July 27, 2023."
-BHVN,Spinocerebellar Ataxia (SCA),Phase 3,2023-07-27 00:00:00,"The FDA informed Biohaven that it would not review the recently submitted NDA application for troriluzole given that the study's primary endpoint was not met and thus, would not permit a substantive review. The communication from the FDA indicated that the Company may request a Type A meeting within 30 days, noted July 27, 2023."
-PFE,Spinocerebellar Ataxia (SCA),Phase 3,2023-07-27 00:00:00,"The FDA informed Biohaven that it would not review the recently submitted NDA application for troriluzole given that the study's primary endpoint was not met and thus, would not permit a substantive review. The communication from the FDA indicated that the Company may request a Type A meeting within 30 days, noted July 27, 2023."
-MRK,Non-muscle invasive bladder cancer (NMIBC),Phase 1,2023-07-28 00:00:00,"Phase 1 dosing initiated, noted July 28, 2023."
-IOBT,Non-muscle invasive bladder cancer (NMIBC),Phase 1,2023-07-28 00:00:00,"Phase 1 dosing initiated, noted July 28, 2023."
-ABEO,Recessive dystrophic epidermolysis bullosa (RDEB),BLA Filing,2023-07-28 00:00:00,"BLA filing package completed, noted July 28, 2023. FDA pre-BLA meeting in August 2023, and expected BLA submission on 3Q, 2023."
-FDMT,Wet age-related macular degeneration (AMD),Phase 1/2,2023-07-29 00:00:00,"Phase 1/2 additional dose response data demonstrated in favor of highest tested dose of 3E10 vg/eye, including 100% reduction in supplemental anti-VEGF injections (4 of 4 evaluable patients injection-free) and a clinically meaningful reduction in central subfield thickness (CST) at 36 weeks in patient population with high anti-VEGF need, noted July 29, 2023."
-CTXR,CTCL non-Hodgkin lymphoma,CRL,2023-07-29 00:00:00,"CRL received on July 29, 2023."
-ANNX,Geographic atrophy,Phase 2,2023-07-30 00:00:00,"Phase 2 results presented at ASRS demonstrated dose and time-dependent protection of visual function in GA across multiple measures, noted July 30, 2023."
-CLSD,Wet AMD using suprachoroidal delivery,Phase 2,2023-07-30 00:00:00,"Phase 2 additional data reported meaningful reductions in Anti-VEGF injection burden with stable to improved CRT through month 6, noted July 30, 2023."
-RGNX,Wet AMD using suprachoroidal delivery,Phase 2,2023-07-30 00:00:00,"Phase 2 additional data reported meaningful reductions in Anti-VEGF injection burden with stable to improved CRT through month 6, noted July 30, 2023."
-GSK,Endometrial Cancer,Approved,2023-07-31 00:00:00,"FDA approved on July 31, 2023. Ahead of PDUFA on Sept. 23, 2023."
-IONS,ATTR cardiomyopathy,Phase 3,2023-07-31 00:00:00,"Phase 3 trial initiation announced January 10, 2020. Phase 3 enrollment completed, noted July 31, 2023."
-ANAB,Endometrial Cancer,Approved,2023-07-31 00:00:00,"FDA approved on July 31, 2023. Ahead of PDUFA on Sept. 23, 2023."
-BPTH,Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS),Phase 2,2023-08-01 00:00:00,"Phase 2 interim analysis reported that in cohort 1, twelve of the fourteen evaluable patients (86%) achieved complete remission (CR/CRi) and two (14%) achieved partial remission (PR), and in cohort 2 eight of the fourteen evaluable patients (57%) achieved complete remission (CR/CRi), two (14%) achieved partial remission (PR) and three (22%) achieved stable disease, noted August 1, 2023."
-CLSD,Diabetic retinopathy,Phase 2,2023-08-01 00:00:00,"Phase 2 additional data reported that 20% of patients achieved a >2-step improvement vs. 10% in control and 54% of patients achieved any DRSS improvement vs. 20% in control, noted August 1, 2023."
-RGNX,Diabetic retinopathy,Phase 2,2023-08-01 00:00:00,"Phase 2 additional data reported that 20% of patients achieved a >2-step improvement vs. 10% in control and 54% of patients achieved any DRSS improvement vs. 20% in control, noted August 1, 2023."
-QLGN,"Pancreatic cancer, Prostate cancer and other solid tumors",Phase 1a,2023-08-01 00:00:00,"IND cleared by FDA, noted August 1, 2023"
-TYRA,Achondroplasia,Phase 2,2023-08-01 00:00:00,"FDA Orphan drug designation (ODD) granted on August 1, 2023."
-ALT,Non-alcoholic fatty liver disease (NAFLD),Phase 2b,2023-08-01 00:00:00,"Phase 2b IMPACT trial enrollment initiated, noted August 1, 2023."
-ICPT,NASH patients with compensated cirrhosis,Phase 3,2023-08-02 00:00:00,"NASH Programs discontinued, noted August 2, 2023."
-ARAV,Platinum Resistant Ovarian Cancer (PROC),Phase 3,2023-08-02 00:00:00,"Phase 3 topline data did not meet primary endpoint of progression-free survival, noted August 2, 2023."
-GTHX,Urothelial carcinoma,Phase 2,2023-08-02 00:00:00,"Phase 2 PFS data reported that PFS was similar between patients receiving trilaciclib prior to gemcitabine/platinum + avelumab and patients receiving gemcitabine/platinum + avelumab alone (median PFS=6.0 months and 6.1 months), noted August 2, 2023."
-MESO,Steroid-refractory acute graft versus host disease (aGVHD) in children,CRL,2023-08-03 00:00:00,"Additional CRL announced August 3, 2023."
-ONCT,Metastatic castration-resistant prostate cancer (mCRPC),Phase 1/2,2023-08-03 00:00:00,"Phase 1/2 study received ""Study May Proceed"" letter by FDA, noted August 3, 2023."
-LUMO,Ebola,Approved,2023-08-03 00:00:00,"Approval in children aged 12 months and older on August 3, 2023."
-MRK,Ebola,Approved,2023-08-03 00:00:00,"Approval in children aged 12 months and older on August 3, 2023."
-ALEC,Frontotemporal Dementia,Phase 2,2023-08-03 00:00:00,"Additional Phase 2 data considered to be uninformative regarding treatment effect, noted August 3, 2023."
-AFMD,"EGFR-expressing tumors, Non-small cell lung cancer, and Squamous cell carcinoma of the head and neck",Phase 1,2023-08-03 00:00:00,"Phase 1 dose-escalation update reported that AFM24 showed meaningful clinical activity in heavily pretreated patients with EGFRmut NSCLC (ORR [13%], DCR [47%]) with significant tumor reductions, including two confirmed PRs and five patients exhibiting stable disease, noted August 3, 2023."
-BIIB,Major depressive disorder (MDD),CRL,2023-08-04 00:00:00,"CRL issued August 4, 2023."
-SAGE,Major depressive disorder (MDD),CRL,2023-08-04 00:00:00,"CRL issued August 4, 2023."
-BIIB,Postpartum Depression,Approved,2023-08-04 00:00:00,"Approved August 4, 2023."
-SAGE,Postpartum Depression,Approved,2023-08-04 00:00:00,"Approved August 4, 2023."
-RCUS,Metastatic castrate-resistant prostate cancer (mCRPC),Phase 1/2,2023-08-07 00:00:00,"Phase 1/2 trial is not expected to demonstrate sufficient clinical benefit in castrate resistant prostate cancer to warrant further investment, noted August 7, 2023."
-PRAX,Epilepsy,Phase 1,2023-08-07 00:00:00,"Phase 1 study demonstrated pharmacodynamic activity across all dose levels for study subjects who received PRAX-628 at first administration as compared with subjects who received a placebo, noted August 7, 2023. Based on these studies and the preclinical results, Praxis intends to advance PRAX-628 into a Phase 2 study in focal epilepsy in the 1H 2024."
-VTGN,Social Anxiety Disorder (SAD),Phase 3,2023-08-07 00:00:00,"Phase 3 topline data met its primary endpoint, noted August 7, 2023."
-PASG,GM1 gangliosidosis (GM1),Phase 1/2,2023-08-07 00:00:00,"Phase 1/2 initial safety data from cohorts 1-4 up to 28 months showed Dose 1 and 2 of PBGM01 were well tolerated and had a favorable safety and immunological profile, noted August 7, 2023."
-SAGE,Major Depressive Disorder (MDD),Phase 3,2023-08-07 00:00:00,"Phase 3 additional data reported that there were no new safety signals identified, noted August 7, 2023."
-OCS,Inflammation and pain following ocular surgery,Phase 3,2023-08-08 00:00:00,"Phase 3 trial met both primary endpoints, noted August 8, 2023."
-DRUG,Dravet Syndrome,Phase 1/2,2023-08-08 00:00:00,"Additional Phase 1/2 cohort 4 data reported an increase in central delta power and robust reduction in central alpha and beta power in active group, as previously reported for Anti-Epileptic Drugs (AEDs) in healthy individuals, noted August 8, 2023."
-NVO,Obesity,Phase 3,2023-08-08 00:00:00,"Phase 3 trial met its primary endpoint, with statistically significant and superior reduction in MACE of 20% for people treated with semaglutide 2.4 mg compared to placebo, noted August 8, 2023."
-PBYI,Small Cell Lung Cancer (SCLC),Phase 1a,2023-08-08 00:00:00,"FDA IND Clearance on August 8, 2023."
-MRTX,MTAP-deleted cancers,Phase 1,2023-08-08 00:00:00,"Phase 1 data reported a safety profile and early signs of clinical activity, noted August 8, 2023."
-VIRX,Epstein-Barr Virus Associated Lymphoma,Phase 1/2,2023-08-08 00:00:00,"Phase 1b/2 data results showed complete responses achieved and ongoing durable responses observed out to approximately 36 months across multiple EBV+ lymphoma subtypes, including some of the most aggressive cancers, noted August 8, 2023."
-TERN,Nonalcoholic steatohepatitis (NASH),Phase 2a,2023-08-08 00:00:00,"Phase 2a topline data reported that the trial met all primary and secondary endpoints, noted August 8, 2023."
-ATAI,Healthy volunteers,Phase 1,2023-08-08 00:00:00,"Phase 1 was generally well-tolerated with no SAE reported. At the 60mg IV dose, rates of sedation and dissociation were consistent with prior studies of PCN-101 at this dose-level, noted August 8, 2023."
-ICVX,Respiratory syncytial virus (RSV) vaccine,Phase 1b,2023-08-08 00:00:00,"Phase 1b 12 month extension trial in older adults, GMTs against RSV through day 365 persisted at ~45-70% of the GMTs at day 28 (for 75 and 250 µg unadjuvanted dosages), noted August 8, 2023."
-PRAX,Essential tremor,Phase 2,2023-08-08 00:00:00,"Phase 2 patients dosed with ulixacaltamide up to 14 weeks showed maintained or improved efficacy results, as measured by mean changes in the modified Activities of Daily Living 11 (mADL111). Patients withdrawing from ulixacaltamide to placebo experienced worsening in mADL11, noted August 8, 2023."
-GRTX,Severe Oral Mucositis (SOM),CRL,2023-08-09 00:00:00,"FDA issued a Complete Response Letter (CRL), noted August 9, 2023."
-PALI,Reduction in adhesions following abdominal and pelvic surgery,Phase 2,2023-08-09 00:00:00,"Phase 2 study did not achieve primary efficacy endpoint of reducing adhesions in LB1148 treated patients compared to placebo treated patients post bowel resection surgery, noted August 9, 2023."
-MRK,Solid tumors,Phase 1/2,2023-08-09 00:00:00,"Phase 1/2 sixth dose escalation cohort data and agent expansion data to showed durable anti-cancer activity observed during monotherapy dose escalation without dose-limiting toxicities. Late-stage pancreatic cancer patient achieved 80% tumor shrinkage with complete regression observed in two of three metastatic lesions in the liver in response to single-agent MDNA11, noted August 9, 2023."
-MDNA,Solid tumors,Phase 1/2,2023-08-09 00:00:00,"Phase 1/2 sixth dose escalation cohort data and agent expansion data to showed durable anti-cancer activity observed during monotherapy dose escalation without dose-limiting toxicities. Late-stage pancreatic cancer patient achieved 80% tumor shrinkage with complete regression observed in two of three metastatic lesions in the liver in response to single-agent MDNA11, noted August 9, 2023."
-ALXO,Myelodysplastic syndromes (MDS),Phase 1b,2023-08-10 00:00:00,"Phase 1b data reported that the evorpacept combination did not substantially improve upon the historical activity of azacitidine alone, noted August 10, 2023."
-JNJ,Multiple myeloma,Approved,2023-08-10 00:00:00,"Approved August 10, 2023."
-REGN,Wet age-related macular degeneration (AMD),Phase 2,2023-08-10 00:00:00,"Phase 2 two-year longer-term data demonstrated that the vast majority of aflibercept 8 mg patients with wAMD could maintain or further extend their dosing intervals. Among those who completed the two-year follow-up, noted August 10, 2023."
-VRCA,Basal cell carcinoma,Phase 2,2023-08-10 00:00:00,"Phase 2 data presented at AAD Innovation Academy show consistency inclinical and histological clearance of treated BCC lesions was observed by Day 49 post-treatment with the 8 mg dose of VP-315, with 4 of 6 subjects (67%) showing complete tumor clearance, noted August 10, 2023."
-XFOR,Severe Congenital Neutropenia (SCN),Phase 2,2023-08-10 00:00:00,"Phase 2 data reported that three participants receiving G-CSF and once-daily oral mavorixafor showing robust increases in ANC, maintenance of ANC levels in the normal range, and the ability to reduce G-CSF dose earlier than anticipated, noted August 10, 2023."
-ANNX,Retinal vein occlusion (RVO),Phase 2,2023-08-11 00:00:00,"Phase 2 data reported a long duration of effect with a single dose of standard of care anti-VEGF treatment in two of five treated patients. These two patients also had some positive effects on visual acuity and the retina already during the four weeks before standard of care treatment was used, noted August 11, 2023."
-JNJ,BRCA-positive mCRPC,Approved,2023-08-11 00:00:00,"Approved August 11, 2023."
-DCTH,Liver-dominant ocular melanoma,Approved,2023-08-14 00:00:00,"FDA Approved on August 14, 2023."
-TCRT,Solid tumors,Phase 1/2,2023-08-14 00:00:00,"Program wind down due to prioritization. Phase 1/2 interim data reported a 83% disease control rate, noted August 14, 2023."
-DSGN,Friedreich ataxia (FA),Phase 1,2023-08-14 00:00:00,"Phase 1 ascending dose data reported that DT-216 was generally well-tolerated and achieved a statistically significant and dose-related increase in frataxin (FXN) mRNA levels in skeletal muscle biopsies, noted August 14, 2023."
-PFE,Multiple Myeloma,Approved,2023-08-14 00:00:00,"FDA Approved on August 14, 2023."
-ADPT,Multiple Myeloma,Approved,2023-08-14 00:00:00,"FDA Approved on August 14, 2023."
-RVNC,Cervical Dystonia,Approved,2023-08-14 00:00:00,"Approved on August 14, 2023."
-CNSP,Glioblastoma (GBM) (adult),Phase 2,2023-08-14 00:00:00,"Phase 2 interim update demonstrated its capability to be an innovative treatment in GBM that is safe and well tolerated, which has the potential to be a novel and effective therapy for this disease, noted August 14, 2023."
-GLTO,Idiopathic pulmonary fibrosis (IPF),Phase 2b,2023-08-15 00:00:00,"Phase 2b trial did not meet its primary endpoint, noted August 15, 2023."
-NVS,Wet macular degeneration,Phase 3,2023-08-15 00:00:00,"Phase 3 trial met its primary endpoint, noted August 15, 2023."
-CMRX,H3 K27M-mutant Glioma,Phase 3,2023-08-16 00:00:00,"Phase 3 data from survival analyses published in Cancer Discovery reported that ONC201 frontline treatment, administered post-radiation therapy, demonstrated a statistically significant increase in mOS from diagnosis versus historical controls, noted August 16, 2023."
-IPSEY,Fibrodysplasia ossificans progressiva (FOP),Approved,2023-08-16 00:00:00,"FDA Approved on August 16, 2023."
-MBIO,B-cell Non-Hodgkin Lymphoma & Chronic Lymphocytic Leukemia (CLL),Phase 1/2,2023-08-16 00:00:00,"Initial Phase 1/2 data reported clinical responses from four of four indolent lymphoma patients, including complete response in follicular lymphoma patient previously treated with CD19 CAR-T cell therapy, noted August 16, 2023."
-QSAM,Bone cancer,Phase 1,2023-08-16 00:00:00,"Initial Phase 1 data reported that treatment was well-tolerated with no serious adverse events, a 56% - 64% decrease in SUV in patient one, and that the first two patients experienced significant pain relief and improved mobility within a week after treatment, noted August 16, 2023."
-FBIO,B-cell Non-Hodgkin Lymphoma & Chronic Lymphocytic Leukemia (CLL),Phase 1/2,2023-08-16 00:00:00,"Initial Phase 1/2 data reported clinical responses from four of four indolent lymphoma patients, including complete response in follicular lymphoma patient previously treated with CD19 CAR-T cell therapy, noted August 16, 2023."
-MRK,Advanced renal cell carcinoma (RCC),Phase 3,2023-08-17 00:00:00,"Phase 3 trial met primary endpoint, noted August 18, 2023."
-PCSA,Gastrointestinal Cancer,Phase 1b,2023-08-17 00:00:00,"Phase 1b interim analysis suggested Processa's novel chemotherapy treatment could improve safety and efficacy in more patients by individualizing the dosing regimen for each patient, noted August 17, 2023."
-IMAB,Growth hormone deficiency,Phase 3,2023-08-17 00:00:00,"Phase 3 trial met its primary endpoint, noted August 17, 2023."
-REGN,"Wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR)",Approved,2023-08-18 00:00:00,"Approved August 18, 2023."
-NBIX,Huntington's disease,Approved,2023-08-18 00:00:00,"Approved August 18, 2023."
-REGN,Chaple,Approved,2023-08-18 00:00:00,"Approved August 18, 2023."
-SGEN,HER2+ Metastatic Breast Cancer (MBC),Phase 3,2023-08-19 00:00:00,"Phase 3 trial met primary endpoint, noted August 19, 2023"
-EXEL,Castration-Resistant Prostate Cancer,Phase 3,2023-08-21 00:00:00,"Phase 3 data reported that the trial met one of two primary endpoints, demonstrating a statistically significant improvement in progression-free survival (PFS) at the primary analysis, noted August 21, 2023."
-IPSEY,Castration-Resistant Prostate Cancer,Phase 3,2023-08-21 00:00:00,"Phase 3 data reported that the trial met one of two primary endpoints, demonstrating a statistically significant improvement in progression-free survival (PFS) at the primary analysis, noted August 21, 2023."
-GILD,Acute myeloid leukemia (AML),Phase 3,2023-08-21 00:00:00,"Partial hold by the FDA on enrollment, noted August 21, 2023."
-GILD,Acute Myeloid Leukemia (AML),Phase 1/2,2023-08-21 00:00:00,"Partial hold on enrollment by FDA, noted August 21, 2023."
-HCM,Primary immune thrombocytopenia (ITP),Phase 3,2023-08-21 00:00:00,"Phase 3 trial met is primary endpoint, noted August 21, 2023."
-PFE,Respiratory Syncytial Virus (RSV) in infants,Approved,2023-08-21 00:00:00,"FDA approval on August 21, 2023."
-RHHBY,1L Non-Small Cell Lung Cancer (NSCLC) PD-L1 high,Phase 3,2023-08-23 00:00:00,"Phase 3 data reported that median overall survival estimates of 22.9 months in the tiragolumab plus Tecentriq arm, and 16.7 months in the Tecentriq monotherapy arm, noted August 23, 2023."
-AKBA,Anemia due to chronic kidney disease (CKD),NDA Filing,2023-08-24 00:00:00,"NDA to be resubmitted, noted August 25, 2023. Upon acceptance of the NDA, Akebia expects the FDA to set a PDUFA date of six months from the date of submission."
-TSHA,Rett syndrome,Phase 1/2,2023-08-24 00:00:00,"FDA granted Fast Track Designation (FTD), noted August 24, 2023."
-GILD,"COVID-19 in people with mild, moderate and severe hepatic impairment",Approved,2023-08-24 00:00:00,"Approved August 24, 2023."
-NVO,"Heart failure with preserved ejection fraction (HFpEF) and obesity, Type 2 diabetes",Phase 3,2023-08-25 00:00:00,"Phase 3 data reported a mean change in the KCCQ-CSS of a 16.6-point increase at 52 weeks with semaglutide 2.4 mg vs 8.7 points with placebo, leading to an estimated treatment difference of 7.8 points, noted August 25, 2023."
-NVS,Multiple sclerosis (MS),Approved,2023-08-25 00:00:00,"Approved August 25, 2023."
-MRK,Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC),Phase 3,2023-08-25 00:00:00,"Phase 3 data reported that at the second analysis, the trial did not demonstrate an improvement in OS compared to KEYTRUDA plus placebo, noted August 25, 2023."
-ESPR,Cardiovascular Diseases,Phase 3,2023-08-26 00:00:00,"Phase 3 total event data presented at ESC reported that bempedoic acid shows 20% risk reduction in MACE-4 and 17% risk reduction in MACE-3, noted August 26, 2023."
-BBIO,Amyloid cardiomyopathy (ATTR-CM),Phase 3,2023-08-27 00:00:00,"Phase 3 data presented at ESC reported an 81% survival rate on acoramidis and over 30 months, patients survived more and were hospitalized less than has been seen in prior controlled studies, noted August 27, 2023."
-ARWR,Cardiovascular disease / Elevated Lipoprotein,Phase 2,2023-08-28 00:00:00,"Phase 2 data reported at ESC noted that results from the off-treatment extension period show that patients previously dosed with ≥75 mg of olpasiran sustained a ~40-50% placebo-adjusted percent reduction in Lp(a) nearly a year after the last dose, noted August 28, 2023."
-AMGN,Cardiovascular disease / Elevated Lipoprotein,Phase 2,2023-08-28 00:00:00,"Phase 2 data reported at ESC noted that results from the off-treatment extension period show that patients previously dosed with ≥75 mg of olpasiran sustained a ~40-50% placebo-adjusted percent reduction in Lp(a) nearly a year after the last dose, noted August 28, 2023."
-TBPH,Neurogenic orthostatic hypotension (nOH),Phase 3,2023-08-28 00:00:00,"Additional subgroup data reported benefits of ampreloxetine ranged from 0.5 to 2.2 point improvements relative to placebo across all subgroup categories and were demonstrated on the OHSA and OHQ composite scores, noted August 28, 2023."
-VALN,Chikungunya Vaccine for adolecents,Phase 3,2023-08-28 00:00:00,"Phase 3 trial data reported that VLA1553 was generally safe and well tolerated in adolescents aged 12 to 17 years, regardless of previous CHIKV infection, noted August 28, 2023."
-ANIP,Severe vasomotor symptoms (hot flashes and night sweats) due to menopause,Approved,2023-08-28 00:00:00,"Approved August 28, 2023."
-NVCR,Ovarian cancer,Phase 3,2023-08-28 00:00:00,"Phase 3 trial did not meet its primary endpoint in the final analysis, noted August 28, 2023."
-NVS,"Atherosclerotic cardiovascular disease (ASCVD), increased risk of ASCVD or heterozygous familial hypercholesterolemia (HeFH)",Phase 3,2023-08-28 00:00:00,"Phase 3 data reported that eight in ten patients achieved target LDL-C threshold, noted August 28, 2023."
-OCUP,Diabetic Retinopathy (DR) / Macular Edema (DME),Phase 2,2023-08-28 00:00:00,"Phase 2 data reported that APX3330 achieved statistical significance in preventing clinically meaningful progression of diabetic retinopathy, noted August 28, 2023."
-BIVI,Parkinson's disease,Phase 2a,2023-08-28 00:00:00,"Phase 2a results reported that in comparison of Day 1 and Day 14 of treatment, PK parameters demonstrated that NE3107 administration did not affect the PK profile of levodopa, noted August 28, 2023."
-BMY,"First-line, lower-risk Myelodysplastic syndromes (MDS)",Approved,2023-08-28 00:00:00,"Approved August 28, 2023."
-MRK,"First-line, lower-risk Myelodysplastic syndromes (MDS)",Approved,2023-08-28 00:00:00,"Approved August 28, 2023."
-BFRI,Actinic Keratosis on face & scalp,Phase 1,2023-08-28 00:00:00,"Phase 1 data reported that treatment was generally well tolerated and all TEAEs were transient, noted August 28, 2023."
-LIAN,Obstructive hypertrophic cardiomyopathy (oHCM),Phase 3,2023-08-28 00:00:00,"Phase 3 data presented at ESC reported that treatment demonstrated improvement in Valsalva LVOT peak gradient, LVOT obstruction, clinical symptoms, health status, cardiac biomarkers, and cardiac structure in Chinese oHCM patients, noted August 28, 2023."
-CLNN,Amyotrophic Lateral Sclerosis,Phase 2,2023-08-29 00:00:00,"Phase 2 OLE data reported a significant median survival benefit of 19.3 months using the rank-preserving structural failure time model (RPSFTM) and a significant 52% decreased risk of ALS clinical worsening events, noted August 29, 2023."
-FGEN,Duchenne Muscular Dystrophy,Phase 3,2023-08-29 00:00:00,"Phase 3 topline data reported that the trial did not meet its primary endpoint, noted August 29, 2023."
-NBIX,Tardive dyskinesia (TD),Phase 3,2023-08-29 00:00:00,"Phase 3 data reported that the mean AIMS total score at baseline was 14.6 and decreased over 48 weeks, with a mean change from baseline of -10.2 , noted August 29, 2023."
-RGNX,"Batten Disease, CLN2",Phase 1,2023-08-30 00:00:00,"Phase 1 initial interim data reported that treatment was well tolerated with no serious adverse events. Key efficacy measures demonstrated sustained levels of TPP1 along with increased intervals between enzyme replacement therapy (ERT) infusions and an 86% reduction in seizure frequency through six month, noted August 30, 2023."
-RGNX,Mucopolysaccharidosis Type I (MPS I),Phase 1/2,2023-08-30 00:00:00,"Phase 1/2 initial interim analysis reported that cognitive function was higher than the age equivalent scores in the available natural history, noted August 30, 2023."
-DNLI,Hunter syndrome MPS II,Phase 1/2,2023-08-30 00:00:00,"Additional data from SSIEM reported that data demonstrate rapid and sustained normalization of CSF heparan sulfate to normal healthy levels and improvement in lysosomal function biomarkers, noted August 30, 2023."
-ORTX,Metachromatic leukodystrophy (MLD),Phase 3,2023-08-31 00:00:00,"Announced long-term results from 39 patients that demonstrated that administration of one-time gene therapy resulted in statistically significant improvement in severe motor impairment-free survival with up to 12 years of follow-up (median 6.76 years), noted August 31, 2023."
-ADCT,Diffuse Large B-Cell Lymphoma (DLBCL),Phase 3,2023-08-31 00:00:00,"Phase 3 updated data from safety lead-in portion of study reported that the overall response rate by central review was 16/20 (80%). A total of 10/20 (50%) and 6/20 (30%) patients attained complete and partial response, respectively, noted August 31, 2023."
-RLYB,Paroxysmal nocturnal hemoglobinuria (PNH); Generalized Myasthenia Gravis (gMG),Phase 1,2023-09-03 00:00:00,"Phase 1 multiple ascending trial data reported maximum exposures of greater than 1 µM and 3 µM, respectively, and greater than 99% reductions in free C5 concentrations, noted September 3, 2023."
-IGMS,Hepatocellular carcinoma (HCC),Phase 1/2,2023-09-05 00:00:00,"Phase 1b/2 interim data reported complete response was recorded in 1 patient, partial response in 2 patients, and stable disease in 2 patients, noted September 5, 2023."
-VTRS,Children Living with HIV,Approved,2023-09-05 00:00:00,"Tentative approval announced September 5, 2023."
-TNXP,fibromyalgia-type Long COVID,Phase 2,2023-09-05 00:00:00,"Phase 2 topline data did not achieve the pre-specified primary endpoint of improving Long COVID pain intensity scores at Week 14, noted September 5, 2023."
-KRYS,Alpha-1 antitrypsin deficiency (AATD),Phase 1a,2023-09-05 00:00:00,"FDA granted Orphan Drug Designation, noted September 5, 2023."
-PFE,Focal Epilepsy,Phase 1,2023-09-05 00:00:00,"Examination of EEG in healthy subjects administered single doses confirmed central nervous system (CNS) activity consistent with effects observed with other antiseizure medications, noted September 5, 2023."
-BHVN,Focal Epilepsy,Phase 1,2023-09-05 00:00:00,"Examination of EEG in healthy subjects administered single doses confirmed central nervous system (CNS) activity consistent with effects observed with other antiseizure medications, noted September 5, 2023."
-AUTL,Pediatric Acute lymphoblastic leukemia (ALL),Phase 1,2023-09-05 00:00:00,"Phase 1 data presented at the Blood journal showed that of 10 responding patients, 5 had emergence of MRD (2) or frank relapse (3) with CD19 and CD22 expressing disease associated with loss of CAR T-cell persistence. Importantly, there were no cases of relapse due to antigen-negative escape, with a median follow-up of 8.7 months. Overall survival was 75% at 6 and 12 months. Six and 12-month event free survival (EFS) were 75% and 60% respectively, noted September 5, 2023."
-RXRX,Clostridium Difficile Infection,Phase 1,2023-09-05 00:00:00,"Phase 1 trial achieved its primary objectives of assessing the safety, tolerability and pharmacokinetic profile of REC-3964. REC-3964 has been well tolerated with no serious adverse events (SAEs) reported, noted September 5, 2023."
-BCDA,Heart Failure,Phase 3,2023-09-05 00:00:00,"Phase 3 review determined that the study is unlikely to meet its primary three-tiered FS efficacy endpoint, as seen from the initial 102 randomized patient set assessed at 12-month follow-up, noted September 5, 2023."
-VBIV,Hepatitis B,Phase 2,2023-09-06 00:00:00,"Additional Phase 2 data significantly increased HBsAg seroconversion rate is strongly associated with BRII-179 treatment and correlates with the increased rate of HBsAg loss3, noted September 6, 2023."
-AZN,Neuromyelitis Optica Spectrum Disorder (NMOSD),CRL,2023-09-06 00:00:00,"CRL issued on September 6, 2023."
-RHHBY,Paroxysmal nocturnal hemoglobinuria (PNH),BLA Filing,2023-09-06 00:00:00,"BLA accepted by FDA, noted Septemeber 6, 2023"
-VBIV,Hepatitis B,Phase 2,2023-09-06 00:00:00,"Phase 2a/2b top-line data showed increased HBsAg loss rate at the end of treatment and 12 weeks follow up, noted September 6, 2023."
-VIR,Hepatitis B,Phase 2,2023-09-06 00:00:00,"Additional Phase 2 data significantly increased HBsAg seroconversion rate is strongly associated with BRII-179 treatment and correlates with the increased rate of HBsAg loss3, noted September 6, 2023."
-TNGX,Solid Tumors,Phase 1a,2023-09-06 00:00:00,"IND cleared by FDA, noted September 6, 2023. Phase 1/2 clinical trial to commence 1H 2024."
-HOTH,Atopic Dermatitis (AD),Phase 1b,2023-09-06 00:00:00,"Phase 1b final results reported that 78% of patients reported that their overall health had improved since starting BioLexa as compared to 22% stating that there was no change in their health, or their health was worse, noted September 6, 2023."
-TRVN,Diabetic neuropathic pain (DNP),Phase 1,2023-09-06 00:00:00,"Phase 1 data demonstrated a statistically significant analgesic effect in the capsaicin-induced model, noted on September 6, 2023."
-AMRX,Attention Deficit Hyperactivity Disorder (ADHD),Approved,2023-09-06 00:00:00,"ANDA approved September 6, 2023."
-GLYC,Healthy volunteers,Phase 1a,2023-09-06 00:00:00,"Phase 1a first cohort dosing initiated, noted September 6, 2023."
-VXRT,Norovirus vaccine,Phase 2,2023-09-06 00:00:00,"Phase 2 study met 5 of 6 primary endpoints,.Vaccination led to a statistically significant reduction in infection rate, a non-statistically significant reduction in norovirus acute gastroenteritis (AGE), and a substantial reduction in viral shedding, noted September 7, 2023."
-AMRX,Acute symptomatic hypocalcemia in pediatric and adult patients,Approved,2023-09-06 00:00:00,"FDA ANDA Approved based on FDA's Competitive Generic Therapy (CGT) designation with 180-day exclusivity on September 6, 2023."
-APLT,Galactosemia,NDA Filing,2023-09-06 00:00:00,"Company pre-NDA meeting with the FDA completed, noted September 6, 2023. NDA submission expected 4Q 2023."
-PFE,Lyme disease,Phase 2,2023-09-07 00:00:00,"Phase 2 data showed that participants seroconverted after the booster dose, yielding seroconversion1 rates (SCRs) of 95.3% and 94.6% for all outer surface protein A (OspA) serotypes in all age groups, noted September 7, 2023."
-VALN,Lyme disease,Phase 2,2023-09-07 00:00:00,"Phase 2 data showed that participants seroconverted after the booster dose, yielding seroconversion1 rates (SCRs) of 95.3% and 94.6% for all outer surface protein A (OspA) serotypes in all age groups, noted September 7, 2023."
-CBAY,Primary biliary cholangitis (PBC),Phase 3,2023-09-07 00:00:00,"Phase 3 registration trial achieved the primary and all key secondary endpoints, noted on September 7, 2023."
-ABBV,Alzheimer’s disease,Phase 2,2023-09-07 00:00:00,"Phase 2 enrollment to be completed, noted September 7, 2023."
-ALNY,Hypertension,Phase 2,2023-09-07 00:00:00,"Phase 2 study met the primary endpoint, noted September 7, 2023."
-DRRX,Alcoholic hepatitis (AH),Phase 2b,2023-09-07 00:00:00,"Phase 2b last patient dosed, noted September 7, 2023"
-INTS,Advanced Soft Tissue Sarcoma,Phase 2,2023-09-07 00:00:00,"Orphan Drug Designation granted by the FDA noted Septemeber 7, 2023."
-ARQT,Atopic dermatitis,Phase 3,2023-09-07 00:00:00,"OLE data reported that 61.5% and 66.2% of participants who rolled over from the roflumilast cream arm in INTEGUMENT-1 or -2 demonstrated a 75% improvement from baseline in Eczema Area and Severity Index (EASI-75) after 28 weeks and 56 weeks, respectively, noted September 7, 2023."
-VBIV,Recurrent glioblastoma multiforme (rGBM),Phase 2b,2023-09-07 00:00:00,"Phase 2b treatment in the primary GBM expected to commenced, noted September 7, 2023."
-FDMT,Wet Age-Related Macular Degeneration (wet AMD),Phase 2,2023-09-07 00:00:00,"Phase 2 enrollment commenced, noted September 7, 2023."
-ALEC,Alzheimer’s disease,Phase 2,2023-09-07 00:00:00,"Phase 2 enrollment to be completed, noted September 7, 2023."
-FULC,Facioscapulohumeral muscular dystrophy (FSHD),Phase 3,2023-09-08 00:00:00,"Phase 3 enrollment completed, noted September 8, 2023"
-BCTX,"Early stage, newly diagnosed, high-risk triple negative breast cancer (TNBC)",Phase 2,2023-09-08 00:00:00,"Phase 2 trial enrollment completed with initial results of Median overall survival of 13.5 months in vs. 6.7-9.8 months for similar patients reported in the literature, noted September 8, 2023."
-SNPX,Alzheimer's disease,Phase 2b,2023-09-09 00:00:00,"Phase 2b data presented at IBRO reported that nearly all pre-specified secondary endpoints were achieved with statistical significance in the server cohort, noted September 9, 2023."
-RNA,Myotonic dystrophy type 1 (DM1),Phase 1/2,2023-09-09 00:00:00,"Phase 1/2 topline data analysis presented at the Myotonic Dystrophy Foundation Annual Conference reported directional improvements in myotonia (vHOT) as early as 6 weeks after dosing with a sustained effect at Month 6, noted September 9, 2023."
-AZN,Non-small cell lung cancer (NSCLC),Phase 3,2023-09-09 00:00:00,"Phase 3 data presented at WCLC reported a reduced the risk of disease progression or death by 38% compared to TAGRISSO alone and a combination extended median PFS by 8.8 months, noted September 9, 2023."
-CING,ADHD,Phase 3,2023-09-09 00:00:00,"Phase 3 trial full results reported improvements on the PERMP scores with a trend towards statistical significance for PERMP ratings over the 16-hour period, noted September 9, 2023."
-AZN,Metastatic non-squamous non-small cell lung cancer (NSCLC),Phase 2,2023-09-09 00:00:00,"Phase 2 data presented at WCLC reported that objective response rates of 49% and 56% with 5.4 mg/kg and 6.4 mg/kg doses, respectively, in primary analysis, noted September 9, 2023."
-MRTX,Non-Small Cell Lung Cancer / Colorectal Cancer,Phase 1b,2023-09-10 00:00:00,"Phase 1/1b two-year follow-up data presented at the World Conference on Lung Cancer reported a durable efficacy with a median overall survival (OS) of 14.1 months and a 2-year OS rate of 31% in patients with previously treated KRASG12C-mutated NSCLC, noted September 10, 2023."
-PHGE,P. aeruginosa in patients with Cystic Fibrosis (CF),Phase 1/2,2023-09-10 00:00:00,"Phase 1b/2 Part 1 data presented at ERS reported that treatment was well-tolerated with no adverse events related to study drug, noted September 10, 2023."
-GRCL,Relapsed/refractory multiple myeloma (RRMM),Phase 1,2023-09-10 00:00:00,"Phase 1 updated data at EHA demonstrated 100% minimal residual disease (MRD) negativity and 82.8% MRD negative stringent complete response (sCR) in a predominantly high-risk RRMM population, noted June 10, 2023."
-IFRX,Chronic Autoimmune and Inflammatory Diseases,Phase 1,2023-09-11 00:00:00,"Phase 1 SAD results demonstrated an excellent safety and tolerability profile and a favorable pharmacokinetic (PK) and pharmacodynamic (PD) profile, confirming INF904´s best-in-class potential, noted September 11, 2023."
-AZN,Non-small cell lung cancer (NSCLC) without actionable genomic alterations,Phase 1b,2023-09-11 00:00:00,"Phase 1b data reported an objective response rates of 77% and 50% and disease control rates of 92% and 93%, respectively, noted September 11, 2023."
-BLRX,Stem-cell mobilization for autologous transplantation,Approved,2023-09-11 00:00:00,"FDA Approved on September 11, 2023."
-BMY,Non-Small Cell Lung Cancer (NSCLC),Phase 3,2023-09-11 00:00:00,"Phase 3 data demonstrated consistent, durable benefits of Opdivo plus Yervoy vs. chemotherapy at six years, regardless of PD-L1 expression, noted September 11, 2023."
-VERU,ER+/HER2- breast cancer,Phase 3,2023-09-11 00:00:00,"Phase 3 enrollment discontinued due to prioritization with Phase 3 data overall response rates of 12.5% are observed in the enobosarm group in a heavily pretreated population versus no responses in the standard of care active control arm. Overall response rate was 20% for enobosarm monotherapy versus 0% for standard of care active control in patients who had ≤3 lines of prior endocrine therapy in the metastatic setting, noted September 11, 2023. ARTEST clinical data further validates the evaluation of enobosarm in the Phase 3 ENABLAR-2 study."
-CRNX,Acromegaly,Phase 3,2023-09-11 00:00:00,"Phase 3 topline data reported that trial met its primary endpoint, noted September 11, 2023."
-GILD,Non-Small Cell Lung Cancer (NSCLC),Phase 2,2023-09-11 00:00:00,"Phase 2 trial data reported that in both cohorts, the ORR was 56%, and DCR was 82%. Median duration of response (DoR) was not reached at the time of data cut-off, and DoR rate at six months was 88% in both cohorts, noted September 11, 2023."
-MRKR,Lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell treatment,Phase 1,2023-09-11 00:00:00,"Phase 1 clinical update showed that patients with Non-Hodgkin's Lymphoma who relapsed after anti-CD19 CAR T cell therapy tolerated initial dose level well and achieved complete response after MT-601 treatment, noted September 11, 2023."
-EYPT,Non-proliferative diabetic retinopathy (NPDR),Phase 2,2023-09-11 00:00:00,"Phase 2 interim analysis of masked data showed that EYP-1901 is well tolerated with no reported drug-related ocular or systemic serious adverse events, noted September 11, 2023."
-IDYA,"Solid tumors, ovarian cancer",Phase 1,2023-09-11 00:00:00,"Phase 1 data reported tumor shrinkage observed in multiple HRD solid tumor patients, including an endometrial cancer subject with a first imaging assessment of a partial response and an 87% reduction of the CA-125 tumor marker, noted September 11, 2023."
-ARWR,Healthy volunteers and Asthma,Phase 1/2,2023-09-11 00:00:00,"Phase 1/2 preliminary clinical data achieved mean target gene knockdown of up to 90% with a maximum of 95% after a single inhaled administration, noted Septemeber 11, 2023."
-MRK,Pulmonary arterial hypertension (PAH),Phase 3,2023-09-11 00:00:00,"Phase 3 interim results from OLE study represent longest safety and efficacy analysis of sotatercept to date; safety profile of sotatercept consistent with previous studies and efficacy improvements maintained after one year of therapy, noted September 11, 2023."
-IVVD,COVID-19 Prevention,Phase 3,2023-09-11 00:00:00,"Phase 3 dosing initiated, noted September 11, 2023."
-ITCI,Bipolar Depression and Major depressive disorder (MDD),Phase 3,2023-09-11 00:00:00,"Phase 3 data continues to demonstrate statical significance. Lumateperone 42mg also met the key secondary endpoint by demonstrating a statistically significant and clinically meaningful reduction in the Clinician's Global Impression scale or CGI compared to placebo at Week 6 in these three populations, noted September 11, 2023."
-TAK,Psoriasis,Phase 2b,2023-09-11 00:00:00,"Additional Phase 2b data reported that the safety and tolerability profile of TAK-279 in the Phase 2b trial was consistent with previous TAK-279 clinical trials, noted September 11, 2023."
-ABUS,Healthy volunteers,Phase 1,2023-09-11 00:00:00,"Phase 1 discontinued, noted September 11, 2023."
-ABUS,Coronavirus,Phase 1,2023-09-11 00:00:00,"Phase 1 trial discontinued, noted September 11, 2023."
-SLRN,Hidradenitis Suppurativa (HS),Phase 2/3,2023-09-11 00:00:00,"Phase 2b/3 data to did not meet statistical significance at week 16, noted Septemeber 11, 2023."
-BNTX,COVID-19 Vaccine (Omicron Booster),Approved,2023-09-11 00:00:00,"FDA booster approved on September 11, 2023."
-MRNA,Covid-19 Omicron Booster,Approved,2023-09-11 00:00:00,"FDA approved on September 11, 2023."
-PFE,COVID-19 Vaccine (Omicron Booster),Approved,2023-09-11 00:00:00,"FDA booster approved on September 11, 2023."
-AZN,Eosinophilic granulomatosis with polyangiitis (EGPA),Phase 3,2023-09-11 00:00:00,"Phase 3 met the primary endpoint, noted September 11, 2023."
-AIM,Early-stage triple negative breast cancer,Phase 1,2023-09-11 00:00:00,"Phase 1 complete topline results confirmed treatment was well tolerated, with promising clinical activity of pathologic complete response (pCR) + microinvasive residual disease (ypTmic) at 66%, comparable to pembrolizumab/neoadjuvant chemotherapy (NAC), noted September 11, 2023."
-VIGL,Adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP),Phase 1,2023-09-11 00:00:00,"Phase 2 data analysis demonstrated that VGL101 continued to have a favorable safety and tolerability profile and proof-of-target engagement in SAD/MAD cohorts up to 60 mg/kg with six-month interim data expected 4Q 2023, noted Septemeber 11, 2023."
-GOVX,Covid-19,Phase 2,2023-09-11 00:00:00,"Phase 2 target enrollment met, noted September 11, 2023."
-ABUS,"Hepatitis B, healthy volunteers",Phase 1,2023-09-11 00:00:00,"Phase 1 dosing commenced, noted September 11, 2023. Phase 1 preliminary data 1H 2024."
-NBIX,Congenital Adrenal Hyperplasia (CAH) - adults,Phase 3,2023-09-12 00:00:00,"Phase 3 study met its primary endpoint at Week 24, Noted September 12, 2023"
-AZN,Non-Small Cell Lung Cancer,Phase 3,2023-09-12 00:00:00,"Phase 3 data presented at WCLC reported statistically significant and clinically meaningful improvement in event-free survival and pathologic complete response with this IMFINZI-based regimen versus neoadjuvant chemotherapy alone followed by surgery, noted September 12, 2023."
-LYRA,Chronic rhinosinusitis,Phase 2,2023-09-12 00:00:00,"Phase 2 top-line results met its primary endpoint with no serious adverse events observed, September 12, 2023."
-NXTC,PD-1 axis inhibitor refractory non-small cell lung cancer (NSCLC),Phase 2,2023-09-12 00:00:00,"Phase 2 data reported that 28% of patients (5/18) had durable clinical benefit with three of these being confirmed responses, noted September 12, 2023."
-ANIP,Menopause symptoms,Approved,2023-09-12 00:00:00,"Approved September 12, 2023."
-LSTA,Solid Tumors,Phase 2a,2023-09-12 00:00:00,"Phase 2a dosing initiated on head and neck squamous cell carcinoma cohort, noted Septemeber 12, 2023."
-VTGN,Premenstrual dysphoric disorder (PMDD),Phase 2a,2023-09-12 00:00:00,"Phase 2a exploratory analysis demonstrated statistically and clinically significant improvement versus placebo, noted Septemeber 12, 2023."
-EIGR,Hepatitis Delta Virus (HDV) infection,Phase 3,2023-09-12 00:00:00,"Phase 3 LIMT-2 trial discontinued due to DSMB recommendation, noted September 12, 2023."
-IOVA,Solid Tumors,Phase 2,2023-09-12 00:00:00,"Phase 2 data presented at WCLC reported that the ORR was 42.1%, noted September 12, 2023."
-NVCT,Non-small cell lung cancer (NSCLC),Phase 1a,2023-09-12 00:00:00,"Phase 1a dose escalation initiated, noted September 12, 2023."
-MRNA,Seasonal influenza,Phase 3,2023-09-13 00:00:00,"Phase 3 trial met all co-primary endpoints, noted September 13, 2023."
-MDGL,Non-alcoholic steatohepatitis (NASH) with liver fibrosis,PDUFA priority review,2023-09-13 00:00:00,https://www.biopharmcatalyst.com/company/MDGL/news/158576
-OCGN,Retinitis Pigmentosa,Phase 1/2,2023-09-13 00:00:00,"Phase 1/2 clinical study update suggested continued positive trends in Best-Corrected Visual Acuity (BCVA) and Multi-Luminance Mobility Testing (MLMT), as well as positive trends in Low-Luminance Visual Acuity (LLVA) among treated eyes 83% (10/12) of subjects demonstrated stabilization or improvement in treated eye either on BCVA or LLVA or MLMT scores from baseline, noted September 13, 2023."
-HOTH,"Aggressive systemic mastocytosis (ASM), mast cell leukemia (MCL), and systemic mastocytosis with associated hematological neoplasm (SM-AHN).",Phase 1a,2023-09-13 00:00:00,"Preclinical Results of Novel HT-KIT Therapeutic Performed at NC State University demonstrated that gastrointestinal Stromal Tumors Cells Rapidly Died Between 48 and 72 Hours After Exposure to HT-KIT. HT-KIT Shows Positive Results in AML, noted September 13, 2023."
-AMGN,Alopecia areata,Phase 2,2023-09-13 00:00:00,"Phase 2 initiated in collaboration with Q32 Bio on September 13, 2023."
-ANTX,Treatment-Refractory MAC Lung Disease,Phase 2/3,2023-09-13 00:00:00,"Phase 2/3 enrollment completed, noted September 13, 2023."
-VINC,Hematologic malignancies,Phase 1,2023-09-14 00:00:00,"IND cleared August 22, 2023. Phase 1 study dosing commenced, noted on September 14, 2023."
-BMY,Spinal Muscular Atrophy (SMA),Phase 3,2023-09-14 00:00:00,"Phase 3 trial to continue dosing, noted November 9, 2022. Phase 3 dosing completed, noted September 14, 2023."
-PFE,Spinal Muscular Atrophy (SMA),Phase 3,2023-09-14 00:00:00,"Phase 3 trial to continue dosing, noted November 9, 2022. Phase 3 dosing completed, noted September 14, 2023."
-SCLX,Acute lower back pain (LBP),Phase 2,2023-09-14 00:00:00,"Phase 2 data reported that none of the subjects in the active group and 3 (8.1%) subjects in placebo group had AEs of special interest, with a meaningful reduction of pain over the first week, noted September 14, 2023."
-AVXL,Mild to moderate Alzheimer’s disease,Phase 2/3,2023-09-14 00:00:00,"Phase 2b/3 full data reported that the least-squares mean (LSM) change from baseline to 48 weeks between the blarcamesine and placebo groups were −1.783; for ADAS-Cog13, and −0.456 for CDR-SB in patients with early Alzheimer's disease, noted September 14, 2023."
-SRNE,Acute lower back pain (LBP),Phase 2,2023-09-14 00:00:00,"Phase 2 data reported that none of the subjects in the active group and 3 (8.1%) subjects in placebo group had AEs of special interest, with a meaningful reduction of pain over the first week, noted September 14, 2023."
-BHVN,Spinal Muscular Atrophy (SMA),Phase 3,2023-09-14 00:00:00,"Phase 3 trial to continue dosing, noted November 9, 2022. Phase 3 dosing completed, noted September 14, 2023."
-GSK,Myelofibrosis,Approved,2023-09-15 00:00:00,"Approved September 15, 2023."
-ELOX,Alport syndrome,Phase 2,2023-09-18 00:00:00,"Phase 2 additional independent confirmation reported that all three patients treated with ELX-02 showed a visual improvement in podocyte foot process effacement post-treatment in kidney biopsies demonstrating the disease modifying effect of ELX-02, noted September 18, 2023."
-ACRS,Healthy volunteers,Phase 1,2023-09-18 00:00:00,"Phase 1 data reported that treatment was was generally well tolerated at all doses, noted September 18, 2023."
-RDHL,H. pylori,Approved,2023-09-18 00:00:00,https://www.biopharmcatalyst.com/company/RDHL/news/159168
-GILD,Large B-cell lymphoma (LBCL) after one prior line of therapy who were deemed ineligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT),Phase 2,2023-09-18 00:00:00,"Phase 2 trial met its primary endpoint, noted September 18, 2023."
-KYMR,Cutaneous T-cell lymphoma (CTCL),Phase 1,2023-09-18 00:00:00,"FDA granted Fast Track Designation in ongoing Phase 1 trial, noted September 18, 2023."
-SXTP,COVID-19 patients with mild-moderate symptoms and low risk of disease progression,Phase 1a,2023-09-18 00:00:00,"IND withdrawn, noted September 18, 2023"
-TCON,Sarcomas,Phase 3,2023-09-18 00:00:00,"Phase 2 pivotal trial satisfied more than the futility threshold of 3 responses out of 46 based on the results of the second and final mandated independent data monitoring committee (IDMC) efficacy review, and the trial will continue as planned, noted September 18, 2023."
-KNTE,Solid Tumors,Phase 1,2023-09-18 00:00:00,https://www.biopharmcatalyst.com/company/KNTE/news/159347
-AIMD,Oral warts in HIV-seropositive patients,Phase 3,2023-09-18 00:00:00,"Ainos plans to pursue a pre-IND meeting with the FDA in advance of planned Phase 3 clinical studies, noted September 18, 2023."
-ABBV,Platysma prominence associated with platysma muscle activity (M21-310),Phase 3,2023-09-18 00:00:00,"Phase 3 trial met all primary and secondary endpoints, noted September 18, 2023."
-SAVA,Alzheimer's disease,Phase 3,2023-09-18 00:00:00,"Phase 3 Data and Safety Monitoring Board (DSMB) recommended that both of Cassava Sciences' Phase 3 studies of simufilam continue as planned, without modification, noted September 18, 2023."
-IGXT,Pain,PDUFA priority review,2023-09-19 00:00:00,"In response to the CRL, Xiromed submitted to the FDA an Amendment to the ANDA, requesting priority review, noted September 19, 2023. In an Amendment Acknowledgement received from the FDA by the company, the FDA granted priority review with a Generic Drug User Fee Act (GDUFA) date for review of the Amendment of March 8, 2024, unless the Agency determines that an inspection is required. Alternatively, if the FDA determines that an inspection is required, the GDUFA goal date is July 8, 2024."
-ARQT,Atopic Dermatitis - ages of 2-5 years old,Phase 3,2023-09-19 00:00:00,"Phase 3 top-line data reported that the trial met all its primary and secondary endpoints, noted September 19, 2023."
-RVMD,"Pancreatic cancer, non-small cell lung cancer (NSCLC), and colorectal cancer.",Phase 1,2023-09-19 00:00:00,"Phase 1 dosing initiated, noted Septemeber 19, 2023."
-ALPMY,Geographic atrophy (GA) secondary to age-related macular degeneration (AMD),Phase 3,2023-09-19 00:00:00,"Phase 3 24 month data confirmed that trial met primary endpoint, noted September 19, 2023."
-DYN,Myotonic Dystrophy Type 1 (DM1),Phase 1/2,2023-09-20 00:00:00,"Phase 1/2 initiated Septmember 6, 2022. Phase 1/2 Orphan Drug Designation was granted on September 20, 2023."
-RLMD,Major Depressive Disorder (MDD),Phase 3,2023-09-20 00:00:00,"Phase 3 results showed that patients newly treated with REL-1017 for up to one year experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and associated functional impairment, noted Septemeber 20, 2023."
-VIR,HIV T cell vaccine,Phase 1,2023-09-20 00:00:00,"Phase 1 dosing initiated, noted September 20, 2023."
-RGLS,Autosomal Dominant Polycystic Kidney Disease (ADPKD),Phase 1,2023-09-20 00:00:00,"Phase 1b data showed that it was well tolerated by all 9 subjects receiving active drug with no safety findings. Increases in both PC1 and PC2 biomarkers were observed. Statistically significant increases in mean PC1 levels were observed at Day 85 and Day 86 (n=9) compared to baseline (36%-41%). Numeric increases in PC2 were observed during the treatment period, although not statistically significant, noted September 20, 2023."
-SPRY,Allergic reactions (type I) including anaphylaxis,CRL,2023-09-20 00:00:00,"CRL announced September 20, 2023."
-SEEL,Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder (ASIB in MDD),Phase 2,2023-09-20 00:00:00,"Phase 2 Part 2 cohort data readout demonstrated early and persistent clinically meaningful reductions in symptoms of depression and acute suicidality, noted September 20, 2023."
-MESO,"Pediatric participants with acute graft versus host disease (aGVHD), following allogeneic hematopoietic stem cell transplant (HSCT)",Phase 3,2023-09-21 00:00:00,"Type A meeting noted the lack of a suitable potency assay for the RYONCIL product used during the Phase 3 trial, new potency assay data to be generated, noted September 21, 2023."
-NAMS,Alzheimer's Disease,Phase 2a,2023-09-21 00:00:00,"Phase 2a data observed reductions of 11% and 12% in 24- and 27-hydroxycholesterol in cerebrospinal fluid (CSF), respectively, indicating potential improvement of cholesterol metabolism in the brain. Observed 8% increase in Aβ42/40 ratio, a key biomarker of AD risk, suggesting improvement in disease pathology, noted September 21, 2023."
-JSPR,Fanconi Anemia (FA),Phase 1b,2023-09-21 00:00:00,"Phase 1b updated results showed that all three patients treated achieved full donor engraftment and full blood count recovery. Briquilimab was well tolerated without any complications, noted September 21, 2023."
-ETNB,Nonalcoholic Steatohepatitis (NASH),Phase 2b,2023-09-21 00:00:00,"Phase 2b trial received Breakthrough Therapy Designation (BTD) granted by the FDA, noted September 21, 2023."
-TRDA,Duchenne Muscular Dystrophy (DMD),Phase 1,2023-09-21 00:00:00,"Phase 1 trial initiated, noted September 21, 2023."
-CBAY,Primary biliary cholangitis (PBC),Phase 3,2023-09-21 00:00:00,"Phase 3/4 study initiated, noted September 21, 2023."
-LLY,Chronic kidney disease (CKD),Approved,2023-09-22 00:00:00,"FDA Approval on September 22, 2023."
-MRK,Metastatic non-small cell lung cancer (NSCLC),Phase 3,2023-09-22 00:00:00,"Phase 3 data reported that there was not an improvement in OS for patients who received KEYTRUDA plus LENVIMA compared to docetaxel, noted September 22, 2023."
-MRK,Nonsquamous non-small cell lung cancer (NSCLC),Phase 3,2023-09-22 00:00:00,"Phase 3 trial did not meet its dual primary endpoints of overall survival (OS) and progression free survival (PFS), noted September 22, 2023."
-KTRA,Newly diagnosed MGMT-unmethylated Glioblastoma Multiform (GBM),Phase 2,2023-09-23 00:00:00,"Additional Phase 2 case study data to be presented at EANO reported that a patient was tumor-free and has survived more than four years as of the last follow-up in March 2023, and another patient had discontinued treatment and a new lesion was found, noted September 23, 2023."
-ASND,Growth Hormone Deficiency - adults,Phase 3,2023-09-23 00:00:00,"Phase 3 resultspresented at ESPE 2023 showed that the majority of children and adolescents treated once weekly with TransCon hGH (lonapegsomatropin) met or exceeded average parental height SDS at time of treatment completion or last visit, noted September 23, 2023."
-MORF,Ulcerative colitis,Phase 2a,2023-09-23 00:00:00,"Phase 2a trial achieved the primary endpoint and demonstrated clinically meaningful improvements across secondary and exploratory measures, noted September 22, 2023."
-APLIF,Parasitic and anaerobic bacterial infections,Approved,2023-09-25 00:00:00,"Approved September 25, 2023."
-CLNN,Amyotrophic Lateral Sclerosis (ALS),Phase 2/3,2023-09-25 00:00:00,"Phase 2/3 post hoc results showed significantly improved survival with a 49% decreased risk of death for the covariate risk-adjusted analyses compared to the largest U.S. clinical database of previous amyotrophic lateral sclerosis (ALS) trials (PRO-ACT), noted September 25, 2023."
-NVS,Gastroenteropancreatic neuroendocrine tumors (GEP-NETs),Phase 3,2023-09-25 00:00:00,"Phase 3 trial met primary endpoint of improvement in progression-free survival (PFS) and key secondary endpoint of objective response rate (ORR), noted September 25, 2023."
-CHRS,Cancer,CRL,2023-09-25 00:00:00,"CRL issued September 25, 2023."
-LQDA,Interstitial lung disease (PH-ILD),PDUFA,2023-09-25 00:00:00,"FDA confirmed resubmission as Class II, PDUFA date assigned on January 24, 2024. Additionally, the FDA may not grant final approval of the PH-ILD indication until after the new clinical investigation exclusivity granted to Tyvaso expires on March 31, 2024, noted September 25, 2023."
-BIOR,Ulcerative Colitis (UC),Phase 1a,2023-09-25 00:00:00,"IND submitted to FDA, noted September 25, 2023."
-IMVT,Autoimmune diseases,Phase 1,2023-09-26 00:00:00,"Phase 1 data reported no dose-related changes in serum albumin or LDL-C, and the mean total IgG reduction from baseline in this MAD cohort was 63%, noted September 26, 2023."
-TLSA,Secondary Progressive Multiple Sclerosis (SPMS),Phase 2a,2023-09-26 00:00:00,"Phase 2a trial in na-SPMS initiated, noted September 26, 2023."
-SLNO,Prader-Willi syndrome (PWS),Phase 3,2023-09-26 00:00:00,"Phase 3 trial met its primary endpoint, noted September 26, 2023."
-INZY,ENPP1 deficiency,Phase 2,2023-09-26 00:00:00,"Phase 2 interim data from cohort 1-3 reported an improvement in the Global Impression of Change (GIC) observed in all three dose cohorts in ABCC6 Deficiency (PXE) trial, noted September 26, 2023."
-PLRX,Primary sclerosing cholangitis (PSC),Phase 2a,2023-09-26 00:00:00,"Phase 2a met its primary and secondary endpoints at the 12-week treatment period, noted September 26. 2023."
-CADL,Non-small cell lung cancer (NSCLC),Phase 2,2023-09-26 00:00:00,"Phase 2 initial data suggests 12-month survival is consistent with an increased tail on the maturing survival curve, noted September 26, 2023."
-IONS,Familial Chylomicronemia Syndrome (FCS),Phase 3,2023-09-26 00:00:00,"Phase 3 trial met its primary efficacy endpoint, noted September 26, 2023."
-VERU,"COVID-19 / Severe Acute Respiratory Syndrome, SARS-CoV-2, Influenza A and B, Respiratory Syncytial Virus (RSV) and other viruses",Phase 3,2023-09-26 00:00:00,"Phase 3 new study authorized by FDA, with an FDA meeting in September 2023 resulted in agreement with FDA on New Phase 3 Clinical Trial for Sabizabulin for Broader Indication, noted September 26, 2023."
-YS,Rabies,Phase 3,2023-09-26 00:00:00,"Phase 3 trial initiated, noted September 26, 2023."
-LUMO,Pediatric Growth Hormone Deficiency (PGHD),Phase 2,2023-09-26 00:00:00,"Phase 2 interim data analysis reported that LUM-201 restored GH secretion to similar levels seen in normally growing children, noted September 26, 2023."
-CRDF,Pancreatic ductal adenocarcinoma (PDAC),Phase 2,2023-09-26 00:00:00,"Phase 2 additional data reported an objective response rate (ORR) of 19% and median progression-free survival (mPFS) of 5.0 months, noted September 26, 2023."
-CRDF,Small cell lung cancer (SCLC),Phase 2,2023-09-26 00:00:00,"Phase 2 safety data from the first six patients by the institutional review board confirmed the trial can continue to enroll as planned, noted September 26, 2023."
-ADVM,Wet age-related macular degeneration (AMD),Phase 2,2023-09-26 00:00:00,"Phase 2 14-week data reported that has been generally well-tolerated, with 90% of subjects were still receiving corticosteroid prophylactic taper, noted September 26, 2023."
-ENSC,Severe Pain Relief,Phase 3,2023-09-26 00:00:00,"Phase 3 data presented at the PAINWeek on September 7, 2023. Phase 3 completion of site initiation visit, noted September 26, 2023."
-UBX,Wet age-related macular degeneration (AMD),Phase 2,2023-09-27 00:00:00,"Phase 2 patients on combination treatment with UBX1325 and aflibercept from weeks 24-48 maintained vision gains achieved at week 24 on aflibercept alone, with greater vision improvement in patients with more severe disease. 40% of UBX1325-treated patients did not require anti-VEGF treatment through 48 weeks and 64% achieved an anti-VEGF treatment-free interval of over 24 weeks, noted Septemeber 27, 2023."
-CYBN,Major Depressive Disorder (MDD),Phase 1b,2023-09-27 00:00:00,"Phase 1b data reported that 100% of patients in the SSRI cohort responded to SPL026 (DMT) with 92% of patients in remission from depression, noted September 27, 2023."
-VBIV,Covid-19,Phase 1,2023-09-27 00:00:00,"Phase 1 interim data reported a 25% reduction in GMT against Wuhan after 5 months vs. peak responses, noted September 27, 2023."
-VTRS,Mydriasis (RM),Approved,2023-09-27 00:00:00,"FDA Approval on September 27, 2023."
-GRCL,Diffuse large B-cell lymphoma (DLBCL),Phase 1,2023-09-27 00:00:00,"Additional Phase 1 data presented at IMS reported an 100% overall response rate (ORR) and a 100% MRD- sCR rate among 19 transplant-eligible, high-risk NDMM patients, noted September 27, 2023."
-CALT,Alport Syndrome,Phase 2,2023-09-27 00:00:00,"Phase 2 to be intiated in 4Q 2023. FDA granted Orphan Drug Designation, noted September 27, 2023."
-TAK,Ulcerative Colitis,Approved,2023-09-27 00:00:00,"FDA Approved on September 27, 2023."
-BCLI,Amytrophic lateral sclerosis (ALS),PDUFA,2023-09-27 00:00:00,"Advisory Committee meeting voted 17-1 that NurOwn did not demonstrate substantial evidence of effectiveness for the treatment of mild to moderate ALS, noted September 27, 2023."
-OCUP,Mydriasis (RM),Approved,2023-09-27 00:00:00,"FDA Approval on September 27, 2023."
-BLRX,First-line pancreatic ductal adenocarcinoma (PDAC),Phase 2,2023-09-28 00:00:00,"Phase 2 trial data presented at the AACR Special pancreatic cancer conference reported that 6 patients (55%) experienced a partial response (PR) of which 4 (36%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion, noted September 28, 2023."
-BNOX,Post-Traumatic Stress Disorder (PTSD),Phase 2b,2023-09-28 00:00:00,"Phase 2b topline data met its primary endpoint showing BNC210 treatment led to a statistically significant reduction in total PTSD symptom severity at 12 weeks. Statistically significant secondary endpoints showed improvements in depressive symptoms and sleep, noted September 28, 2023."
-MRK,Pulmonary arterial hypertension (PAH),PDUFA,2023-09-28 00:00:00,"PDUFA date on March 26, 2024."
-IMGN,Cancer - ovarian cancer and relapsed endometrial cancer,Phase 3,2023-09-28 00:00:00,"Additional Phase 3 data reported at ESGO noted that in patients with prior PARPi, ORR in the ELAHERE arm was 45%, including 7 CRs, compared to 17%, with no CRs, in the IC chemotherapy arm, noted September 28, 2023."
-VSTM,KRAS mutant advanced solid tumors,Phase 1/2,2023-09-28 00:00:00,"Phase 1/2 data reported an overall response rate (ORR) of 42% (11 of 26) in evaluable patients with low grade serous ovarian cancer (LGSOC), noted September 28, 2023."
-IMNN,Ovarian cancer,Phase 1/2,2023-09-28 00:00:00,"Phase 1/2 interim data reported efficacy trends in PFS, demonstrating a delay in disease progression in the treatment arm of approximately 33% compared with the control arm, with the hazard ratio nearing the required value. Preliminary OS data follows a similar trend, showing an approximate 9-month improvement in the treatment arm over the control arm, noted September 28, 2023."
-FOLD,Pompe Disease,Approved,2023-09-28 00:00:00,"FDA Approved on September 28, 2023."
-NBTX,Pancreatic cancer,Phase 1,2023-09-28 00:00:00,"Phase 1 data reported a 92.3% local disease control rate (12/13) and a median Overall Survival of 21 months, noted September 28, 2023."
-BXRX,Hemophilia A,Phase 1/2,2023-09-28 00:00:00,"FDA granted Orphan Drug Designation, noted September 28, 2023."
-BIIB,Rheumatoid arthritis (RA),Approved,2023-09-29 00:00:00,"FDA Biosimilar of ACTEMRA approved on September 29, 2023."
-GPCR,Type 2 Diabetes,Phase 1b,2023-09-29 00:00:00,"Phase 1b results reported that GSBR-1290 demonstrated significant weight loss supporting once-daily (QD) dosing, noted September 29, 2023."
-ABBV,Relapsed or refractory multiple myeloma,Phase 3,2023-09-29 00:00:00,"Phase 3 data reported that it showed improvement in median PFS of 9.9 months compared to 5.8 months with the combination of study comparator pomalidomide and dexamethasone; however, the results did not reach statistical significance, noted September 29, 2023."
-RHHBY,Relapsed or refractory multiple myeloma,Phase 3,2023-09-29 00:00:00,"Phase 3 data reported that it showed improvement in median PFS of 9.9 months compared to 5.8 months with the combination of study comparator pomalidomide and dexamethasone; however, the results did not reach statistical significance, noted September 29, 2023."
-MBRX,Acute Myeloid Leukia (AML),Phase 1b,2023-10-02 00:00:00,"Phase 1b portion of Phase 1B/2 study demonstrated preliminary CR/CRi rate of 33%, noted Octobeer 2, 2023."
-LGND,ER+/HER2- breast cancer,Phase 3,2023-10-02 00:00:00,"Phase 3 result presented at NAMS 2023 showed that younger age, non-visceral disease, prior tamoxifen and a longer total duration of AI use may be associated with higher baseline vaginal and/or vulvar symptomatology, noted October. 2, 2023."
-PRAX,Early-seizure-onset SCN2A developmental and epileptic encephalopathy (DEE),Phase 3,2023-10-02 00:00:00,"Phase 3 results from preliminary analysis of PRAX-222 Part 1 showed 44% median reduction in seizures after three doses for SCN2A-gain-of-function pediatric patients, noted October 2, 2023."
-NVTA,Early-seizure-onset SCN2A developmental and epileptic encephalopathy (DEE),Phase 3,2023-10-02 00:00:00,"Phase 3 results from preliminary analysis of PRAX-222 Part 1 showed 44% median reduction in seizures after three doses for SCN2A-gain-of-function pediatric patients, noted October 2, 2023."
-ATAI,Treatment Resistant Depression,Phase 1,2023-10-02 00:00:00,"Phase 1 completed, noted October 2, 2023."
-TAK,NSCLC with EGFR exon 20 insertion mutations,Phase 3,2023-10-02 00:00:00,"Phase 3 trial withdrawn voluntarily after the confirmatory trial, which did not meet its primary endpoint, noted October 2, 2023."
-ATAI,Treatment Resistant Depression,Phase 1,2023-10-02 00:00:00,"Phase 1 data reported that treatment was well-tolerated with a favorable safety profile, and dose-dependent increases in exposure were observed, noted October 02, 2023."
-NVS,IgA nephropathy (IgAN),Phase 3,2023-10-02 00:00:00,"Phase 3 data reported that met its pre-specified interim analysis primary endpoint, noted October 2, 2023."
-LLY,Moderate-to-severe atopic dermatitis (AD),CRL,2023-10-02 00:00:00,"CRL issued October 2, 2023."
-SNDX,Relapsed/refractory (R/R) acute leukemias,Phase 2,2023-10-02 00:00:00,"Phase 2 trial met its primary endpoint at the protocol-defined interim analysis stage with a complete remission (CR) or a CR with partial hematological recovery (CRh) rate of 23% among the 57 efficacy evaluable patients in the pooled KMT2Ar acute leukemia cohort, noted October 2, 2023."
-ZVRA,Idiopathic hypersomnia (IH),Phase 2,2023-10-02 00:00:00,"Phase 2 interim data reported that marked improvements in patient-reported assessments of key IH symptoms from the open-label titration phase, including excessive daytime sleepiness, sleep inertia, and brain fog, noted October 2, 2023."
-APLS,Paroxysmal Nocturnal Hemoglobinuria (PNH),Approved,2023-10-02 00:00:00,"FDA Approved on October 2, 2023."
-PDSB,Cervical cancer,Phase 2a,2023-10-02 00:00:00,"Additional Phase 2a data to be reported at the American Society for Radiation Oncology (ASTRO 2023) demonstrated that patients treated with PDS0101 had greater clearance of cfDNA as compared to those treated with SOC, noted October 2, 2023."
-ASND,Hypoparathyroidism,Phase 3,2023-10-02 00:00:00,"Phase 3 clinical trial data presented at ATA, showed that 81% of adults with chronic post-surgical hypoparathyroidism treated with TransCon PTH (palopegteriparatide) achieved independence from conventional calcium and active vitamin D therapy while maintaining normal serum calcium levels during the 26-week blinded portion of the trial, compared to 6% taking placebo, noted October 2, 2023."
-MIRM,Cerebrotendinous xanthomatosis (CTX),Phase 3,2023-10-02 00:00:00,"Phase 3 data met the primary endpoint of reduction in bile alcohols (urine 23S-pentol) was highly statistically significant, noted October 2, 2023."
-ANIP,"Acute exacerbations of multiple sclerosis, rheumatoid arthritis, systemic lupus erythematous and ulcerative colitis",Approved,2023-10-02 00:00:00,"1-ml vial approved October 2, 2023."
-GALT,Non-alcoholic steatohepatitis (NASH) with cirrhosis,Phase 2/3,2023-10-03 00:00:00,"4th DSMB concluded that NAVIGATE can continue as designed, without modifications, noted October 3, 2023."
-ALXO,2nd line or greater gastric/gastroesophageal junction cancer,Phase 2,2023-10-03 00:00:00,"Phase 2 data reported a confirmed overall response rate for evorpacept combination treatment was 52% compared to 22% for control treatment, noted October 3, 2023."
-ACRS,Atopic dermatitis,Phase 2b,2023-10-03 00:00:00,"Phase 2b trial enrollment completed, noted October 3, 2023"
-IRON,Polycythemia vera (PV),Phase 1,2023-10-03 00:00:00,"Phase 1 initiated, noted October 3, 2023."
-PPBT,Squamous cell carcinoma of the head & neck (SCCHN),Phase 1/2,2023-10-03 00:00:00,"Phase 1/2 data showed that 2 out of 4 SCCHN patients at the highest dose cohort demonstrated a confirmed partial response, noted October 3, 2023."
-IMMX,Multiple myeloma,Phase 1/2,2023-10-03 00:00:00,"Phase 1b/2a updated data reported a 100% (9/9) overall response rate and 67% (6/9) complete response rate (MRD 10-5) observed in heavily pre-treated patients, noted October 3, 2023."
-VRTX,Type 1 Diabetes,Phase 1/2,2023-10-03 00:00:00,"Phase 1/2 long term data reported that two patients with at least 1 year of follow-up met the criteria for the primary endpoint of elimination of severe hypoglycemic events (SHEs) and HbA1c <7.0%, noted October 3, 2023."
-RGNX,Duchenne Muscular Dystrophy (DMD),Phase 1/2,2023-10-03 00:00:00,"Phase 1/2 additional data shared at the World Muscle Society Congress reported that in the patient aged 4.4 years old, RGX-202 microdystrophin expression was measured to be 38.8% compared to control, and in the patient aged 10.6 years old, RGX-202 microdystrophin expression was measured to be 11.1% compared to control, noted October 3, 2023."
-BDRX,Recurrent Glioblastoma (GBM),Phase 1,2023-10-03 00:00:00,"Phase 1 Cohort A enrollment completed, noted October 3, 2023."
-IPSEY,Glabellar and lateral canthal lines,CRL,2023-10-03 00:00:00,"CRL received October 3, 2023."
-NVAX,Covid-19,Approved,2023-10-03 00:00:00,"EUA approved October 3, 2023."
-NBTX,Head and Neck Cancer,Phase 1,2023-10-04 00:00:00,"Phase 1 final data presented at ASTRO reported an overall response rate (ORR) of 81.8% (36/44) with a complete response rate (CRR) of 63.6% (28/44), noted October 4, 2023."
-VCYT,Prostate cancer,Phase 3,2023-10-04 00:00:00,"Phase 3 trial validation of a genomic classifier presented at the ASTRO meeting noting that only the Decipher Prostate risk score was independently associated with metastasis-free survival (MFS; HR 1.12, 95% CI) and distant metastasis (DM; sHR 1.22, 95% CI), compared to standard risk factors including Gleason score, T-stage and prostate-specific antigen (PSA) level, noted October 4, 2023."
-IKT,Multiple System Atrophy (MSA),Phase 2,2023-10-04 00:00:00,"Orphan Drug Designation granted by FDA on October 4, 2023."
-MYMD,Sarcopenia and frailty,Phase 2,2023-10-04 00:00:00,"Phase 2 new data showed statistically significant results across Cohort 4 (1050mg), noted October 4, 2023."
-VIRX,Epstein Barr Virus-associated cancers,Phase 2,2023-10-04 00:00:00,"Phase 2 trial demonstrated overall and complete response rates of 40%; follow-up from the Phase 1b/2 study demonstrated median duration of response extended to 17.3 months, noted October 4, 2023."
-PRTC,Ulcerative colitis (UC),Phase 2,2023-10-04 00:00:00,"Phase 2 dosing was initiated and FDA granted fast track designation (FTD), noted October 4, 2023."
-RHHBY,Babies with pre-symptomatic spinal muscular atrophy (SMA),Phase 3,2023-10-04 00:00:00,"Phase 3 OLE met its primary endpoint with 80% of babies sitting without support for at least 5 seconds after 1 year of Evrysdi, noted October 4, 2023."
-GANX,Parkinson's Disease,Phase 1,2023-10-04 00:00:00,"Phase 1 trial dosing commenced, noted October 4, 2023."
-AKRO,Nonalcoholic Steatohepatitis,Phase 2b,2023-10-04 00:00:00,"Phase 2b results published at the Lancet Gastroenterology & Hepatology showed that both EFX doses achieved statistical significance on primary and secondary histopathology endpoints after 24 weeks, noted October 4, 2023."
-MRK,Localized muscle-invasive urothelial carcinoma (MIUC),Phase 3,2023-10-05 00:00:00,"Phase 3 trial met one of its dual primary endpoints of disease-free survival (DFS), noted October 5, 2023."
-OKYO,Dry Eye Disease,Phase 2,2023-10-05 00:00:00,"Phase 2 data reported a dropout rate at 5.4% and that treatment was well tolerated, noted October 5, 2023."
-NBIX,Congenital Adrenal Hyperplasia (CAH) - children,Phase 3,2023-10-05 00:00:00,"Phase 3 trial met primary endpoint, noted October 5, 2023."
-LGVN,Alzheimer's Disease,Phase 2a,2023-10-05 00:00:00,"Phase 2a topline data reported that trial met primary endpoints of safety across all study groups, noted October 5, 2023."
-MVIR,Advanced hepatocellular carcinoma (HCC),Phase 2a,2023-10-05 00:00:00,"Phase 2a data reported that 3 patients achieved Partial Response and 10 patients Stable Disease, providing 17% Overall Response Rate (ORR) and 72% Disease Control Rate (DCR), noted October 5, 2023."
-AMGN,Non-small cell lung cancer (NSCLC),BLA Filing,2023-10-05 00:00:00,"FDA Oncologic Drugs Advisory Committee (ODAC) voted 2-10 against the question of if the primary endpoint, progression-free survival (PFS) per blinded independent central review (BICR), be reliably interpreted in CodeBreaK200, noted October 5, 2023."
-LCTX,Geographic atrophy (GA),Phase 1/2,2023-10-05 00:00:00,"Phase 1/2 results presented at EURETINA Congress reported that 5 patients had an average of 4.4 letter BCVA gain by 3 months and 12.8 letter BCVA gain by 1 year compared to baseline, noted October 5, 2023."
-PPBT,2L metastatic pancreatic cancer (PDAC),Phase 1/2,2023-10-06 00:00:00,"Phase 1 biomarker data demonstrated that CM24 treatment significantly reduced the level of NET marker in patients' serum, noted October 6, 2023."
-ARQT,Plaque psoriasis in children,Approved,2023-10-06 00:00:00,"Approved for treatment of children aged 6 - 11 on October 6, 2023."
-OCS,Diabetic macular edema (DME),Phase 3,2023-10-06 00:00:00,"Phase 3 data presented at EURETINA noted that 6 times a day dosing of OCS-01 was a highly effective Loading Dose, noted October 6, 2023."
-VTYX,Ulcerative Colitis (UC),Phase 2,2023-10-09 00:00:00,"Phase 2 top-line data results showed that at 60 mg achieved the primary endpoint of clinical remission with a high rate of complete endoscopic remission, noted on October 9, 2023."
-COYA,Alzheimer’s Disease (AD),Phase 2,2023-10-09 00:00:00,"Phase 2 enrollment completed, noted October 9, 2023."
-IMUX,Progressive Multiple Sclerosis,Phase 2,2023-10-09 00:00:00,"Phase 2 24-Week data from first half of patients shows improvements in biomarker NfL, Consistent throughout the overall population as well as all subtypes, noted October 9, 2023."
-BBIO,Limb Girdle Muscular Dystrophy Type 2i (LGMD2i),Phase 2,2023-10-09 00:00:00,"Phase 2 long-term data at Month 21 demonstrate a well-tolerated safety profile, and stabilization in 10 meter walk test (10MWT), 100-m timed test (100mTT), and the North Star Assessment (NSAD) scores, noted October 9, 2023."
-TNYA,Heart Failure with Preserved Ejection Fraction,Phase 1,2023-10-09 00:00:00,"Phase 1 data presented at HFSA demonstrated safety and tolerability in healthy participants with dose-proportional pharmacokinetics and robust target engagement, noted October 9, 2023."
-ALNY,Wild-type ATTR amyloidosis patients with cardiomyopathy,CRL,2023-10-09 00:00:00,"CRL issued by the FDA on October 9, 2023. As a result of the CRL, the Company will no longer pursue an expanded indication for patisiran in the US."
-ANAB,Generalized pustular psoriasis,Phase 3,2023-10-09 00:00:00,"Phase 3 top-line data met its primary endpoint in the study population achieving rapid clearance of pustulation, erythema and scaling through Week 4 after a single dose of 750mg IV imsidolimab. Top-line data also demonstrate a favorable safety and tolerability profile, noted October 9, 2023."
-RNA,Myotonic dystrophy type 1 (DM1),Phase 1/2,2023-10-09 00:00:00,"Phase 1/2 enrollment into open label extension trial commenced August 2, 2022. Phase 1/2 new data demonstrated improvement in additional functional measures augmenting previously reported positive data that demonstrated improvements in functional assessments of myotonia (video hand opening time, or vHOT), strength (Quantitative Muscle Testing total score, or QMT) and mobility (10-meter walk run test, or 10mWRT and the Timed Up and Go test, or TUG)., noted October 9, 2023."
-AKRO,Nonalcoholic steatohepatitis (NASH),Phase 2b,2023-10-10 00:00:00,"Phase 2b top line data showed that a trend was observed for the primary endpoint of fibrosis improvement at 36 weeks, with 22% and 24% of the 28mg and 50mg EFX-treated groups, respectively, compared with 14% for placebo, noted October 10, 2023."
-BTAI,Solid Tumors,Phase 2,2023-10-10 00:00:00,"Phase 2 trial showed a median OS of 13.6 months and a 12-month survival rate of 56.5%., noted October 10, 2023."
-CAPR,Duchenne Muscular Dystrophy (DMD),Phase 2,2023-10-10 00:00:00,"Phase 2 data presented at the World Muscle Society reported that the mean PUL 2.0 decline after 24-months of treatment with CAP-1002 was 2.8 points versus a 7.7-point decline on average observed over 24-months in the placebo, noted October 10, 2023."
-BFRI,Actinic keratosis (AK),Approved,2023-10-10 00:00:00,"Approved October 10, 2023."
-INO,HPV 6 and HPV 11-associated Recurrent respiratory papillomatosis,Phase 1/2,2023-10-10 00:00:00,"Phase 1/2 received feedback from the FDA that data could support INOVIO's submission of a BLA for review under the FDA's accelerated approval program. The FDA also advised that the company's previously planned Phase 3 trial would not be required to support this submission, noted October 10, 2023."
-ATHX,Ischemic stroke,Phase 3,2023-10-10 00:00:00,"Phase 3 trial was insufficiently powered to achieve the primary endpoint, noted October 10, 2023."
-GRTS,COVID-19 vaccine,Phase 1,2023-10-11 00:00:00,"Data presented at IDweek reported that treatment was well tolerated in both HIV-negative participants and PLWH irrespective of SARS-CoV-2 serostatus at baseline, October 11, 2023."
-GRTS,COVID-19 booster (60+),Phase 1,2023-10-11 00:00:00,"Additional Phase 1 data reported at IDweek noted that durable binding and high neutralizing antibodies were induced and sustained for up to at least 12 months, noted October 11, 2023."
-INCY,Vitiligo,Phase 2,2023-10-11 00:00:00,"Phase 2 trial initiated March 2021. Phase 2b study results shared at EADV reported that the total body depigmentation improvement from baseline as measured by the Total Vitiligo Area Scoring Index (T-VASI) at Week 52 for povorcitinib 15-to-75 mg, 45 mg, 75 mg and placebo-to-75 mg were 40.7%, 42.7%, 41.3% and 18.1%, respectively, noted October 11, 2023."
-GRTS,COVID-19 vaccine,Phase 1,2023-10-11 00:00:00,"Phase 1 data reported that all doses were well tolerated in both HIV-negative participants and PLWH irrespective of SARS-CoV-2 serostatus at baseline, noted October 11, 2023."
-RHHBY,Multiple sclerosis (MS) or primary progressive MS,Phase 3,2023-10-11 00:00:00,"Phase 3 data reported that treatment was comparable to IV infusion in providing rapid and sustained depletion of B cells and near-complete suppression of MRI lesion activity in the brain over 24 weeks, noted October 11, 2023."
-HALO,Multiple sclerosis (MS) or primary progressive MS,Phase 3,2023-10-11 00:00:00,"Phase 3 data reported that treatment was comparable to IV infusion in providing rapid and sustained depletion of B cells and near-complete suppression of MRI lesion activity in the brain over 24 weeks, noted October 11, 2023."
-RIGL,COVID-19,Phase 2/3,2023-10-11 00:00:00,"Phase 2/3 trial enrollment ceased based on the recommendations of DSMB, noting that here was an extremely low likelihood of fostamatinib providing benefits related to the primary outcome, noted October 11, 2023."
-TPST,Hepatocellular carcinoma (HCC),Phase 1/2,2023-10-11 00:00:00,"Phase 1b/2 trial had a confirmed objective response rate of 30% for the TPST-1120 triplet arm versus 13.3% for the atezolizumab + bevacizumab control arm; duration of response (""DoR"") has not yet been reached, noted October 11, 2023."
-PDSB,Metastatic Prostate Cancer,Phase 1,2023-10-11 00:00:00,"First in human safety and immune data presented at Cytokines reported a decrease in PSA levels, and that all doses of the combination were well-tolerated with one patient experiencing Grade 4 neutropenia, noted October 11, 2023."
-PFE,BRAFV600E-mutant metastatic non-small cell lung cancer (NSCLC),Approved,2023-10-12 00:00:00,"Approved October 12, 2023."
-TEVA,Inflammatory conditions,CRL,2023-10-12 00:00:00,"CRL received October 12, 2023."
-ALVO,Inflammatory conditions,CRL,2023-10-12 00:00:00,"CRL received October 12, 2023."
-LLY,Crohn's disease,Phase 3,2023-10-12 00:00:00,"Phase 3 trial met the co-primary and all major secondary endpoints, noted October 12, 2023."
-CYT,"Solid tumors, Ovarian cancer",Phase 1,2023-10-12 00:00:00,"Additional Phase 1 data reported that two patients had a confirmed partial response, one additional patient achieved an unconfirmed partial response, seven patients had stable disease and one patient had progressive disease, noted October 12, 2023."
-PMVP,Solid tumors,Phase 1/2,2023-10-12 00:00:00,"Phase 1/2 updated results presented at AACR-NCI-EORTC reported that the overall response rate (ORR) was 38% (6/16 evaluable patients) at the Recommended Phase 2 Dose (RP2D) of 2000 mg daily and 34% (13/38) in the efficacious dose range, noted October 12, 2023."
-MRK,Solid tumors,Phase 1/2,2023-10-12 00:00:00,"Phase 1/2 updated results presented at AACR-NCI-EORTC reported that the overall response rate (ORR) was 38% (6/16 evaluable patients) at the Recommended Phase 2 Dose (RP2D) of 2000 mg daily and 34% (13/38) in the efficacious dose range, noted October 12, 2023."
-RLAY,Cholangiocarcinoma (CCA),Phase 1,2023-10-12 00:00:00,"Phase 1 data from non-CCA expansion cohort presented at AACR-NCI-EORTC reported a 35% overall response rate (ORR), and nine of 26 patients experienced a partial response (PR), noted October 12, 2023."
-INCY,Hidradenitis suppurativa,Phase 2,2023-10-12 00:00:00,"Phase 2 secondary analysis presented at EADV reported that a large proportion of patients who received any dose of povorcitinib from Day 1 achieved T VASI50 (37.0% 45.2%) and F VASI75 (48.4% 58.6%) responses at Week 52, noted October 12, 2023."
-ENTA,Respiratory Syncytial Virus (community-acquired),Phase 2b,2023-10-12 00:00:00,"Phase 2b data shared at IDWeek 2023 reported that EDP-938 has a high barrier to clinical resistance, a single resistant mutation was detected in 1 of 37 sequenced EDP-938-treated participants October 12, 2023."
-ONTX,Recessive Dystrophic Epidermolysis Bullosa-Associated Squamous Cell Carcinoma,Phase 2,2023-10-12 00:00:00,"Phase 2 data shared at the EADV reported that two patients achieved complete cutaneous responses of 12 months or more, one patient experienced metastatic disease progression, and one patient remains on study, noted October 12, 2023."
-RHHBY,Multiple sclerosis (MS),Phase 2,2023-10-13 00:00:00,"Phase 2 showed that fenebrutinib crosses the blood-brain barrier with the potential to act directly on the chronic inflammation related to multiple sclerosis (MS). More than 90% relative reduction in new/enlarging T2 lesions and new T1 gadolinium-enhancing (Gd+) lesions with fenebrutinib beginning at eight week, noted October 13, 2023."
-NUVL,ALK non-small cell lung cancer (NSCLC),Phase 1,2023-10-13 00:00:00,"Phase 1 trial showed preliminary signs of activity observed in heavily pre-treated patients with ALK-positive NSCLC, including in subgroups of patients who have previously received a 2nd generation ALK TKI and lorlatinib, have brain metastases, or have single or compound ALK resistance mutations, noted October 13, 2023."
-LLY,Atopic Dermatitis,Phase 1,2023-10-13 00:00:00,"Phase 1b data presented at EADV 2023 showed dose-dependent efficacy reported across all endpoints for REZPEG demonstrating a rapid onset of action and continuing benefit for 36 weeks after 12-week treatment period, noted October 13, 2023."
-NKTR,Atopic Dermatitis,Phase 1,2023-10-13 00:00:00,"Phase 1b data presented at EADV 2023 showed dose-dependent efficacy reported across all endpoints for REZPEG demonstrating a rapid onset of action and continuing benefit for 36 weeks after 12-week treatment period, noted October 13, 2023."
-PFE,Ulcerative colitis,Approved,2023-10-13 00:00:00,"FDA Approved on October 13, 2023."
-TRVI,Prurigo Nodularis (PN),Phase 2/3,2023-10-13 00:00:00,"Phase 2/3 long-term data also supports the continued effectiveness of Haduvio in reducing itch over 52 weeks for the participants who remained in the study, noted October 13, 2023."
-ANIX,Ovarian Cancer,Phase 1,2023-10-13 00:00:00,"Phase 1 completed treatment of the first patient cohort, noted October 13, 2023."
-ASLN,Atopic dermatitis (AD),Phase 2b,2023-10-13 00:00:00,"Phase 2b topline new data from a posthoc analysis of patients with severe disease (baseline EASI score at least 21), representing 63% of ITT patients, show monthly dosing with 600 mg eblasakimab for 16 weeks led to a 74.5% reduction in EASI score and EASI-75 of 53.6%, noted October 13, 2023."
-RPTX,Solid Tumors,Phase 1,2023-10-13 00:00:00,"Phase 1 initial data from Module 1 and 2 presented at plenary session at AACR-NCI-EORTC International Conference suggested treatment with lunresertib in combination with camonsertib could result in efficacy outcomes for patients in the gynecological cancer setting. In this area, we're still seeing unmet patient needs despite current therapies, noted October 13, 2023."
-IMUX,Relapsing-remitting multiple sclerosis (RMS),Phase 2,2023-10-13 00:00:00,"Phase 2 data presented at ECTRIMS reported that VidoCa was associated with a Nfl reduction from baseline up to W6 of -3% for the pooled 30 and 45mg VidoCa group compared to +2.5% for placebo, and up to W24 of -19% and +7%, respectively, noted October 13, 2023."
-NCNA,Colorectal Cancer,Phase 1/2,2023-10-13 00:00:00,"Phase 1b/2 achieved a longer progression-free survival as compared to their first-line treatment with 5-FU-based Therapy, noted October 13, 2023."
-NCNA,2L Colorectal cancer,Phase 2,2023-10-13 00:00:00,"Phase 2 patients recruiting well with no new safety signals, noted October 13, 2023."
-INZY,ABCC6 deficiency,Phase 1/2,2023-10-13 00:00:00,"Phase 1/2 interim clinical data presented at ASBMR reported that treatment was generally well-tolerated on October 13, 2023."
-ACRV,"Platinum-resistant ovarian,(PROC) endometrial, and urothelial cancers.",Phase 2,2023-10-13 00:00:00,"Phase 2 preliminary data shared at AACR-NCI-EORTC reported that ACR-368 that enables identification of responders to ACR-368 treatment, noted October 13, 2023"
-RVMD,Solid Tumors,Phase 1,2023-10-13 00:00:00,"Phase 1 preliminary data shared at AACR-NCI-EORTC reported a median time to response of 1.3 months, and median time on treatment of 3.5 months in NSCLC, with a median time to response of 1.4 months, and median time on treatment of 2.4 months in CRC, noted October 13, 2023."
-KOD,Retinal vein occlusion (RVO),Phase 3,2023-10-13 00:00:00,"Phase 3 one year primary data from the Retina Society meeting reported that Tarcocimab treated patients had a ~30% higher chance of not requiring any additional doses versus aflibercep, noted October 13, 2023."
-KOD,Treatment-Naive Wet Age-Related Macular Degeneration (AMD),Phase 3,2023-10-13 00:00:00,"Phase 3 data presented at the Retina Society meeting reported a favorable safety profile with low rates of intraocular inflammation and no cases of intraocular inflammation with vasculitis or vascular occlusion, noted October 13, 2023."
-KOD,Diabetic Macular Edema (DME),Phase 3,2023-10-13 00:00:00,"Phase 3 data presented at the Retina Society meeting reported that 1/2 of patients achieved 6-month dosing at the primary endpoint, noted October 13, 2023."
-NVCT,Ovarian Clear Cell Carcinoma,Phase 1,2023-10-13 00:00:00,"Phase 1 data presented at AACR-NCI-EORTC reported that NXP800 induced phosphorylation of eIF2a via activation of the stress activated kinase GCN2, noted October 13, 2023."
-INCY,Atopic dermatitis (AD) in children (age ≥2 to <12 years),Phase 3,2023-10-13 00:00:00,"Phase 3 8- week analysis data shared at EADV in children (age ≥2 to <12 years) with atopic dermatitis (AD) achieved significant efficacy, as defined by the Investigator's Global Assessment-treatment success (IGA-TS), following eight weeks of treatment, noted October 13, 2023."
-BDTX,Glioblastoma multiforme (GBM) and NSCLC,Phase 1,2023-10-14 00:00:00,"Phase 1 clinical data presented at AACR-NCI-EORTC meeting reported that five of the 13 patients with either intrinsic driver, acquired resistance or complex mutations had a confirmed partial response (PR), noted October 14, 2023."
-MREO,Osteogenesis Imperfecta,Phase 2,2023-10-14 00:00:00,"Additional Phase 2 data reported that the annualized fracture rate across all 24 patients in the Phase 2 portion of the study was reduced by 67%, noted October 14, 2023."
-RARE,Osteogenesis Imperfecta,Phase 2,2023-10-14 00:00:00,"Additional Phase 2 data reported that the annualized fracture rate across all 24 patients in the Phase 2 portion of the study was reduced by 67%, noted October 14, 2023."
-ENTX,Osteoporosis,Phase 2,2023-10-14 00:00:00,"Phase 2 data presented at ASBMR showed that an increase in plasma ionized calcium should result in decreased secretion and plasma concentrations of endogenous PTH(1-84), noted October 14, 2023"
-TRVN,Epilepsy and other CNS disorders,Phase 1,2023-10-16 00:00:00,"Full safety and tolerability data showed that TRV045 was well tolerated with results generally consistent with prior first-in-human study, noted October 16, 2023."
-IMUX,"Celiac disease, healthy volunteers",Phase 1,2023-10-16 00:00:00,"Phase 1 data reported that treatment has been well tolerated, with no systematic clinically relevant findings relative to safety and tolerability, noted October 16, 2023."
-CLSD,Wet age-related macular degeneration,Phase 1/2,2023-10-16 00:00:00,"Phase 1/2a results demonstrated the key benefits targeting the site of disease at the back of the eye, noted October 16, 2023."
-IKT,Parkinson’s disease,Phase 2,2023-10-16 00:00:00,"Phase 2 update showed that at the end of study timepoint, participants administered the 200 mg dose had a combined Part 2 and Part 3 score that was lower by an average of -8.7 points. By contrast, the combined placebo score increased by an average of +1.7 points, a -10.4 point spread between actively treated versus placebo participants, noted October 16, 2023."
-CFRX,Gram-negative infections,Phase 1a,2023-10-16 00:00:00,"IND safety review completed by FDA on October 16, 2023."
-ABBV,Crohn's disease,Phase 3,2023-10-16 00:00:00,"Phase 3 data reported that the trial met all primary and secondary endpoints, noted October 16, 2023."
-BNOX,Social Anxiety Disorder (SAD),Phase 3,2023-10-16 00:00:00,End of Phase 2 meeting minutes resulted in favorable outcome for the company which confirmed agreement with the FDA on its Phase 3 clinical trial expected to commence in 1Q 2024.
-AMGN,KRAS mutant non-small cell lung cancer (NSCLC),Phase 1/2,2023-10-16 00:00:00,"Phase 1/2 initial data reported that the confirmed objective response rate (ORR) was 25% (3/12) across efficacy-evaluable patients and seen in both KRAS G12C inhibitor resistant (14.3%; 1/7) and naïve (40%; 2/5) patients, noted October 16, 2023."
-VSTM,KRAS mutant non-small cell lung cancer (NSCLC),Phase 1/2,2023-10-16 00:00:00,"Phase 1/2 initial data reported that the confirmed objective response rate (ORR) was 25% (3/12) across efficacy-evaluable patients and seen in both KRAS G12C inhibitor resistant (14.3%; 1/7) and naïve (40%; 2/5) patients, noted October 16, 2023."
-NCNA,Solid tumors,Phase 2,2023-10-16 00:00:00,"Phase 1/2 part 2 for both as a monotherapy in solid tumors and in combination with the anti-PD-1 therapy pembrolizumab in patients with metastatic cutaneous melanoma showed that treatment has been well tolerated both as a monotherapy and in combination with pembrolizumab. Encouraging signs of efficacy, including tumor volume reductions and prolonged time on treatment have been observed in both the monotherapy and combination cohorts, noted October 16, 2023."
-SNY,Hematological malignancies,Phase 1/2,2023-10-16 00:00:00,"Phase 1/2 data from ESMO abstract reported that 3/8 patients achieved complete remission (CR), noted October 16, 2023."
-BMY,Stage IIB or IIC melanoma,Approved,2023-10-16 00:00:00,"Approved October 13, 2023."
-IPHA,Hematological malignancies,Phase 1/2,2023-10-16 00:00:00,"Phase 1/2 data from ESMO abstract reported that 3/8 patients achieved complete remission (CR), noted October 16, 2023."
-MOR,Crohn's disease,Phase 3,2023-10-16 00:00:00,"Phase 3 data reported that in the combination 54% of patients reached a clinical remission, noted October 16, 2023."
-IPHA,Squamous Cell Carcinoma of the Head and Neck (SCCHN),Phase 2,2023-10-16 00:00:00,"Phase 2 results reported that D+M 1 partial response (PR) was recorded and stable disease (SD) was observed in 11 pts (26%), noted October 16, 2023."
-OMER,IgA nephropathy,Phase 3,2023-10-16 00:00:00,"Phase 3 9-month data did not meet its primary endpoint, as a result Omeros will not submit an application for approval of narsoplimab in this indication and will discontinue the ARTEMIS-IGAN clinical trial, noted October 16, 2023."
-JNJ,Crohn's disease,Phase 3,2023-10-16 00:00:00,"Phase 3 data reported that in the combination 54% of patients reached a clinical remission, noted October 16, 2023."
-MRK,"Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer (NSCLC)",Approved,2023-10-16 00:00:00,"Approved on October 16, 2023."
-RARE,Osteogenesis Imperfecta,Phase 2b,2023-10-16 00:00:00,"Phase 2b data demonstrated that treatment with setrusumab (UX143) significantly reduced the incidence of fractures in patients with osteogenesis imperfecta (Gr) with at least six months of follow-up and continues to demonstrate ongoing and meaningful improvements in lumbar spine bone mineral density (BMD), noted October 16, 2023."
-APRE,Solid tumors,Phase 1/2,2023-10-16 00:00:00,"Phase 1/2a data presented at AACR-NCI-EORTC reported that no dose-limiting toxicities have been reported to date with persistent tumor-reducing effect, noted October 16, 2023."
-REGN,Stage II to IV Cutaneous Squamous Cell Carcinoma (CSCC),Phase 2,2023-10-16 00:00:00,"Phase 2 data from ESMO reported a median duration of follow-up was 18.7 months, and 1 of 10 pts with MPR experienced recurrence, noted October 16, 2023."
-APRE,Solid tumors,Phase 1/2,2023-10-16 00:00:00,"Phase 1/2a dose expansion cohort being on track to be initiated in 2Q 2024, additionally, data presented at AACR-NCI-EORTC reported that no dose-limiting toxicities have been reported to date with persistent tumor-reducing effect, noted October 16, 2023."
-PBYI,Rb-deficient head and neck squamous cell cancer,Phase 1/2,2023-10-16 00:00:00,"Phase 1/2 data reported that the median PFS was 1.4 months, and the median overall survival (OS) was 13.5 months, noted October 16, 2023."
-ZLAB,Non-small cell lung cancer (NSCLC),Phase 3,2023-10-16 00:00:00,"Phase 3 data from ESMO abstract reported that quality of life data showed no statistically significant difference between patients who received TTFields therapy together with standard systemic therapies, noted October 16, 2023."
-NVCR,Non-small cell lung cancer (NSCLC),Phase 3,2023-10-16 00:00:00,"Phase 3 data from ESMO abstract reported that quality of life data showed no statistically significant difference between patients who received TTFields therapy together with standard systemic therapies, noted October 16, 2023."
-MLTX,Hidradenitis suppurativa,Phase 2,2023-10-16 00:00:00,"Phase 2 24-week topline data reported that 57% of patients continuously treated with 120mg achieved a HiSCR75 response and 38% achieved HiSCR90, noted October 16, 2023."
-VECT,Short bowel syndrome - colon-in-continuity,Phase 2,2023-10-16 00:00:00,"Additional Phase 2 data reported that 33% of the patients achieving clinical response and PS volume reduction reached a statistically significant 40% at week 24 and the effect was maintained with a 52% volume reduction at week 52, noted October 16, 2023."
-PRLD,Solid tumors and hematological malignancies,Phase 1,2023-10-16 00:00:00,"Phase 1 data reported that 8 (27.6%) patients had stable disease (SD) as the best response and the median PFS was 1.25 months, noted October 16, 2023."
-EVLO,"Psoriasis, healthy volunteers",Phase 2,2023-10-17 00:00:00,"Phase 2 study did not achieve its primary endpoint, noted October 17, 2023."
-GMDA,Follicular and diffuse large B cell lymphomas,Phase 1,2023-10-17 00:00:00,"Phase 1 data showed promising early evidence of anti-tumor activity in patients with relapsed/refractory B cell non-Hodgkin lymphoma, noted October 16, 2023."
-GLUE,MYC-driven solid tumors,Phase 1/2,2023-10-17 00:00:00,"Phase 1/2 initial data study demonstrated favorable tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles in heavily pre-treated patients with lung and high-grade neuroendocrine cancers., noted October 17, 2023"
-BOLT,Solid Tumors,Phase 1/2,2023-10-17 00:00:00,"Phase 1/2 initiated, noted October 17, 2023."
-ARDX,Serum phosphorus - chronic kidney disease (CKD) on dialysis,Approved,2023-10-17 00:00:00,"Approved October 17, 2023."
-BMY,Non-metastatic non-small cell lung cancer,Phase 3,2023-10-17 00:00:00,"Phase 3 reported patients treated with neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo, the risk of disease recurrence, progression or death was reduced by 42%, noted October 17, 2023."
-BMEA,Acute myeloid leukemia (AML),Phase 1,2023-10-17 00:00:00,"Phase 1 dosing initiated, noted October 17, 2023."
-BMY,Urothelial carcinoma,Phase 3,2023-10-17 00:00:00,"Phase 3 data presented at ESMO reported that Opdivo in combination with cisplatin-based chemotherapy reduced the risk of death by 22%, demonstrating a median OS of 21.7 months vs. 18.9 months with chemotherapy alone, noted October 17, 2023."
-VIGL,Healthy volunteers,Phase 1,2023-10-17 00:00:00,"Phase 1 trial dosing initiated, noted October 17, 2023."
-VKTX,Obesity,Phase 1,2023-10-18 00:00:00,"Phase 1 data demonsted that 28 days of once-weekly treatment with VK2735 resulted in reductions in subjects' liver fat content and plasma lipid levels, both from baseline and as compared to placebo, noted October 18, 2023."
-TAK,Complex Crohn's Perianal Fistulas (CPF),Phase 3,2023-10-18 00:00:00,"Phase 3 trial did not meet its primary endpoint, noted October 18, 2023."
-RHHBY,Non-small cell lung cancer (NSCLC),Phase 3,2023-10-18 00:00:00,"Phase 3 data reported that treatment reduces the risk of disease recurrence or death by 76%, noted October 18, 2023."
-PCVX,Invasive Pneumococcal Disease (IPD),Phase 1/2,2023-10-19 00:00:00,"IND cleared by FDA, noted October 19, 2023"
-MRK,HER2-positive gastric or Gastroesophageal junction (GEJ) adenocarcinoma,Phase 3,2023-10-20 00:00:00,"Phase 3 trial data presented at ESMO demonstrated a statistically significant PFS improvement in advanced HER2-positive gastric or GEJ adenocarcinoma in tumors expressing PD-L1 (Combined Positive Score [CPS] ≥1) compared to trastuzumab and chemotherapy alone October 20, 2023."
-AZN,Anaemia of myelodysplastic syndromes (MDS),Phase 3,2023-10-20 00:00:00,"Phase 3 data presented at ESMO reported that treatment demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of pathologic complete response (pCR) versus neoadjuvant chemotherapy alone, noted October 20, 2023."
-FGEN,Anaemia of myelodysplastic syndromes (MDS),Phase 3,2023-10-20 00:00:00,"Phase 3 data presented at ESMO reported that treatment demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of pathologic complete response (pCR) versus neoadjuvant chemotherapy alone, noted October 20, 2023."
-MRK,"Resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC)",Phase 3,2023-10-20 00:00:00,"Phase 3 data presented at ESMO 23 demonstrated statistically significant improvement in overall survival versus neoadjuvant placebo plus chemotherapy, noted October 20, 2023."
-PFE,"Meningococcal Vaccine, Adolescents",Approved,2023-10-20 00:00:00,"FDA approved on October 20, 2023."
-MRK,"High-Risk, Early-Stage ER+/HER2- Breast Cancer",Phase 3,2023-10-20 00:00:00,"Phase 3 data presented at ESMO reported that treatment significantly improved pCR rate compared to neoadjuvant placebo plus chemotherapy (24.3% vs. 15.6%, respectively), noted October 20, 2023."
-SNY,Chronic spontaneous urticaria (CSU),CRL,2023-10-20 00:00:00,"CRL issued by the FDA, noted October 20, 2023."
-BHC,Acne vulgaris,Approved,2023-10-20 00:00:00,"Approved on October 20, 2023."
-AMAM,PSMA Expressing Tumors,Phase 1,2023-10-20 00:00:00,"Phase 1 data presented at ESMO reported that 52% (12/23) of patients experienced a ≥50% PSA reduction, and ≥90% PSA reduction observed in 6% (1/16) and 36% (5/14) of patients at 1.4 mg/kg (Cohort 4) and 2.0 mg/kg (Cohort 6), respectively, noted October 20, 2023."
-ZYME,Gastric/gastroesophageal junction adenocarcinoma (G/GEJC),Phase 1/2,2023-10-20 00:00:00,"Phase 1b/2 data presented at ESMO reported that the confirmed objective response rate by investigator (INV) was 75.8% and median progression-free survival was 16.7 months, noted October 20, 2023."
-MRTX,Non-Small Cell Lung Cancer (NSCLC),Phase 2,2023-10-20 00:00:00,"Phase 2 data presented at ESMO 2023 reported that in patients with PD-L1 TPS ≥50%, adagrasib + pembrolizumab demonstrated a higher response rate (63%) than expected with pembrolizumab monotherapy (39–45%3,4), noted October 20, 2023."
-BGNE,Gastric/gastroesophageal junction adenocarcinoma (G/GEJC),Phase 1/2,2023-10-20 00:00:00,"Phase 1b/2 data presented at ESMO reported that the confirmed objective response rate by investigator (INV) was 75.8% and median progression-free survival was 16.7 months, noted October 20, 2023."
-REGN,Chronic spontaneous urticaria (CSU),CRL,2023-10-20 00:00:00,"CRL issued by the FDA, noted October 20, 2023."
-AGEN,"Advanced Solid tumors, Colorectal cancer",Phase 1b,2023-10-21 00:00:00,"Phase 1b data presented at ESMO reported an overall response rate (ORR) of 24% was observed, compared to 2.8% reported with standard of care (SOC), and a 12-month overall survival (OS) of 74% and median OS (mOS) not yet reached, noted October 21, 2023."
-BMY,Stage IIA to IIIB non-small cell lung cancer (NSCLC),Phase 3,2023-10-21 00:00:00,"Phase 3 data presented at ESMO reported that NIVO + chemo/NIVO improved pCR rates (25.3% vs 4.7%; odds ratio, 6.64 [95% CI, 3.40–12.97]) and MPR rates (35.4% vs 12.1%; odds ratio: 4.01 [2.48–6.49]) vs chemo/PBO, noted October 21, 2023."
-KURA,Head and neck squamous cell carcinomas (HNSCC),Phase 2,2023-10-21 00:00:00,"Phase 2 data presented at ESMO reported that the Tipifarnib ORR was higher in 2L setting than 3L+ setting (29% vs. 15%), noted October 21, 2023."
-BGNE,Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma,Phase 3,2023-10-21 00:00:00,"Phase 3 data presented at ESMO reported that OS in the TIS arm was significantly improved compared with the PBO arm in the ITT population (median OS: 15.0 mo vs 12.9 mo, respectively; HR=0.80 [95% CI: 0.70, 0.92]; 1-sided P=0.0011), noted October 21, 2023."
-BGNE,Hepatocellular Carcinoma (HCC),Phase 2,2023-10-21 00:00:00,"Phase 2 poster presented at ESMO reported that NV-assessed ORR was 35.5% with O+T+B vs. 37.5% with T+B, noted October 21, 2023."
-BGNE,Esophageal Squamous Cell Carcinoma (ESCC),Phase 2,2023-10-21 00:00:00,"Phase 2 data presented at ESMO reported that INV-assessed ORR was 30.6% with O+T vs. 20.6% with P+T; hazard ratio (HR) of INV-assessed PFS was 0.93, noted October 21, 2023."
-PFE,"Claudin-18 isoform 2-positive (CLDN18.2+), HER2−, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma",Phase 3,2023-10-21 00:00:00,"Phase 3 data presented at ESMO reported that median PFS was 11.0 vs 8.9 mo and median OS was 18.2 vs 15.6 mo, noted October 21, 2023."
-ALPMY,"Claudin-18 isoform 2-positive (CLDN18.2+), HER2−, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma",Phase 3,2023-10-21 00:00:00,"Phase 3 data presented at ESMO reported that median PFS was 11.0 vs 8.9 mo and median OS was 18.2 vs 15.6 mo, noted October 21, 2023."
-LLY,Medullary thyroid cancer (MTC),Phase 3,2023-10-21 00:00:00,"Phase 3 data presented at ESMO reported that selpercatinib demonstrated superior PFS vs control in the ITT-pembro (HR: 0.465, 95% CI: 0.309, 0.699; p-value: 0.0002) and ITT populations (HR: 0.482, 95% CI: 0.331, 0.700; p-value: 0.0001), noted October 21, 2023."
-ARVN,Castration-resistant prostate cancer (CRPC),Phase 1/2,2023-10-22 00:00:00,"Updated data from the ongoing Phase 1/2 trial presented at ESMO reported a median rPFS of 11.1 months in patients harboring AR 878/875 mutations and without co-occurring AR L702H mutations, and PSA50 rates of 54% in patients with tumors harboring AR 878/875 mutations and without co-occurring AR L702H, noted October 22, 2023."
-OLMA,"HR+, HER2- Breast Cancer",Phase 1/2,2023-10-22 00:00:00,"Phase 1/2 monotherapy data presented at ESMO reported that the median PFS was 4.6 months with a CBR of 40%; in patients with ESR1 mutations at baseline, the median PFS was 5.6 months with a CBR of 52%, noted October 22, 2023."
-BMY,Melanoma,Phase 2/3,2023-10-22 00:00:00,"Phase 2/3 data presented at ESMO reported that response to NIVO+RELA was associated with increased LAG-3+ CD4+ T cells at week 4, but on-treatment modulation of peripheral CD8+ T cells was not associated with NIVO+RELA efficacy, noted October 22, 2023."
-RVMD,Advanced Solid Tumors,Phase 1b,2023-10-22 00:00:00,"Phase 1/1b data shared at ESMO reported that the objective response rate was 38 percent, with one patient achieving a complete response (CR) as a best response and 14 patients achieving a partial response, noted October 22, 2023."
-FHTX,Metastatic Uveal Melanoma (mUM),Phase 1,2023-10-22 00:00:00,"Phase 1 clinical data presented at ESMO reported that 1 patient treated at the 7.5 mg QD continuous dose level experienced a DLT of Grade 3 keratitis, noted October 22, 2023."
-RYZB,Gastroenteropancreatic neuroendocrine tumors,Phase 1b,2023-10-22 00:00:00,"Phase 1b data presented at ESMO reported that the confirmed ORR was 29.4%, with all five patients having a confirmed PR, noted October 22, 2023."
-BGNE,Cervical Cancer (CC),Phase 2,2023-10-22 00:00:00,"Phase 2 data presented at ESMO reported that the ORR was 22.5%, with 13 complete responses; 76.8% had a durable response of ≥6 mo, noted October 22, 2023."
-EPIX,Metastatic castration-resistant prostate cancer (mCRPC),Phase 1,2023-10-22 00:00:00,"Phase 1 updated data presented at ESMO reported a PSA50 of 88%, PSA90 of 69%, and PSA <0.2 ng/mL of 56%, noted October 22, 2023."
-IOBT,Metastatic solid tumors,Phase 2,2023-10-23 00:00:00,"Additional Phase 2 data presented at ESMO reported that 10 out of 18 evaluable NSCLC patients (56%) had achieved a partial response as their best overall response and 3 out of 6 evaluable SCCHN patients had achieved partial response as their best overall response, noted October 23, 2023."
-MRUS,Solid tumors - NRG1,Phase 1/2,2023-10-23 00:00:00,"Phase 1/2 data update presented at ESMO showed a 37% ORR and 14.9 months median DOR in 78 evaluable NRG1+ NSCLC patients and 42% ORR and 9.1 months median DOR in 33 evaluable NRG1+ PDAC patients. Sufficient clinical data expected in 1H 2024 to support potential BLA submissions, noted October 23, 2023."
-HARP,Small cell lung cancer,Phase 1/2,2023-10-23 00:00:00,"Phase 1/2 data from ESMO reported a confirmed response rate 35% (11/31), across all tumor types and patient cohorts treated with 1 mg priming dose, and a 32% (6/19) confirmed response rate in patients with small cell lung cancer (SCLC), noted October 23, 2023."
-ALPMY,Untreated locally advanced or metastatic urothelial cancer (la/mUC),Phase 3,2023-10-23 00:00:00,"Phase 3 data presented at ESMO reported a median OS of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months in the chemotherapy arm, significantly prolonged OS, reducing the risk of death by 53% compared to treatment with chemotherapy, noted October 23, 2023."
-MRK,Untreated locally advanced or metastatic urothelial cancer (la/mUC),Phase 3,2023-10-23 00:00:00,"Phase 3 data presented at ESMO reported a median OS of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months in the chemotherapy arm, significantly prolonged OS, reducing the risk of death by 53% compared to treatment with chemotherapy, noted October 23, 2023."
-SGEN,Untreated locally advanced or metastatic urothelial cancer (la/mUC),Phase 3,2023-10-23 00:00:00,"Phase 3 data presented at ESMO reported a median OS of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months in the chemotherapy arm, significantly prolonged OS, reducing the risk of death by 53% compared to treatment with chemotherapy, noted October 23, 2023."
-GMAB,Cervical Cancer,Phase 3,2023-10-23 00:00:00,"Additional data presented at ESMO that the overall survival (OS) was statistically significantly prolonged with TIVDAK, demonstrating a 30% reduction in the risk of death compared with chemotherapy, noted October 22, 2023."
-EXEL,Advanced Neuroendocrine Tumors,Phase 3,2023-10-23 00:00:00,"Phase 3 data from ESMO 23 reported that the trial met the primary objective for each cohort, demonstrating that cabozantinib provided dramatic improvements in median progression-free survival (PFS) for the patients in the pNET and epNET cohorts, noted October 23, 2023."
-ADXS,Desmoid tumors,Phase 2/3,2023-10-23 00:00:00,"Phase 2 data presented at ESMO showed that 1.2 mg once daily treatment achieved Overall Response Rate of 83% in the evaluable population, AL102 1.2 mg once daily treatment resulted in 88% reduction in tumor volume and 85% reduction in T2W signal intensity, noted October 23, 2023."
-AYLA,Desmoid tumors,Phase 2/3,2023-10-23 00:00:00,"Phase 2 data presented at ESMO showed that 1.2 mg once daily treatment achieved Overall Response Rate of 83% in the evaluable population, AL102 1.2 mg once daily treatment resulted in 88% reduction in tumor volume and 85% reduction in T2W signal intensity, noted October 23, 2023."
-AZN,Untreated advanced or metastatic triple negative breast cancer (TNBC),Phase 1/2,2023-10-23 00:00:00,"Phase 1b/2 data reported a confirmed objective response rate (ORR) of 79% (95% confidence interval [CI]: 67-88) including six complete responses (CRs) and 43 partial responses (PRs), noted October 23, 2023."
-TOVX,Head and Neck Squamous Cell Carcinoma,Phase 1,2023-10-23 00:00:00,"Phase 1 data shared at ESMO 23 showed enhanced patient survival, correlating with VCN-01 mediated increases in the CPS score, a key determinant of outcomes with anti-PD-(L)1 checkpoint inhibitor therapies, noted October 23, 2023."
-AZN,Endometrial cancer (EC),Phase 3,2023-10-23 00:00:00,"Phase 3 results presented at ESMO reported statistically significant and clinically meaningful PFS benefit vs CP in the ITT population, with the interim OS data being immature (27.7%) yet with a trend towards benefit, noted October 21, 2023."
-ARVN,Metastatic castration-resistant prostate cancer (mCRPC),Phase 1/2,2023-10-23 00:00:00,"Phase 1/2 data presented at ESMO reported a PSA50 of 41% in patients with tumors harboring any AR LBD mutation, and a PSA50 of 50% in patients with any tumor harboring an AR L702H mutation, noted October 23, 2023."
-MRK,Metastatic solid tumors,Phase 2,2023-10-23 00:00:00,"Additional Phase 2 data presented at ESMO reported that 10 out of 18 evaluable NSCLC patients (56%) had achieved a partial response as their best overall response and 3 out of 6 evaluable SCCHN patients had achieved partial response as their best overall response, noted October 23, 2023."
-SGEN,Cervical Cancer,Phase 3,2023-10-23 00:00:00,"Additional data presented at ESMO that the overall survival (OS) was statistically significantly prolonged with TIVDAK, demonstrating a 30% reduction in the risk of death compared with chemotherapy, noted October 22, 2023."
-MRNA,"Personalized cancer vaccine, high-risk melanoma",Phase 2,2023-10-23 00:00:00,"Phase 2 additional data presented at ESMO reported that local recurrence was more common in MRs; MNRs had more distant events. This trend was supported by stronger separation in DMFS vs RFS between MRs and MNRs, noted October 23, 2023."
-AZN,Non-small cell lung cancer (NSCLC),Phase 3,2023-10-23 00:00:00,"Phase 3 reduced the risk of disease progression or death by 25% in overall population and by 37% in patients with non-squamous tumors , noted October 23, 2023."
-MRK,Ovarian cancer,Phase 1,2023-10-23 00:00:00,"Phase 1 data presented at ESMO reported that the confirmed overall response rate in patients with measurable disease was 38% (13 of 34): 67% (including 1 CR) at 4.8 mg/kg, 33% (5/15) at 6.4 mg/kg, and 31% (4/13) at 8.0 mg/kg, with two patients with unconfirmed partial responses were still on treatment, noted October 23, 2023."
-BMY,Non-small cell lung cancer (NSCLC),Phase 3,2023-10-23 00:00:00,"Phase 3 data presented at ESMO reported that 3-y EFS and OS rates were 72% vs 47% and 85% vs 66%, respectively, noted October 23, 2023."
-BNTX,Solid tumors,Phase 1/2,2023-10-23 00:00:00,"Phase 1/2 additional data presented at ESMO demonstrated that the application of CARVac increases the persistence of the adoptively transferred autologous CAR-T cells, noted October 23, 2023."
-BGNE,Stage II-IIIA non-small cell lung cancer (NSCLC),Phase 3,2023-10-23 00:00:00,"Phase 3 data presented at ESMO reported that MPR & pCR rates were significantly improved with TIS + CT vs CT, noted October 23, 2023."
-AZN,"HR Positive, HER2 Negative Breast Cancer",Phase 3,2023-10-23 00:00:00,"Phase 3 data presented at ESMO showed reduction of the risk of disease progression or death by 37%, providing a 2-month median PFS benefit, and was well tolerated in post-endocrine therapy setting, noted October 23, 2023."
-NVS,Metastatic castration-resistant prostate cancer (mCRPC),Phase 3,2023-10-23 00:00:00,"Phase 3 trial met its primary endpoint with a clinically meaningful and statistically significant benefit in radiographic progression-free survival, noted October 23, 2023."
-AZN,Multiple HER2-expressing advanced solid tumors,Phase 2,2023-10-23 00:00:00,"Phase 2 data presented at ESMO 23 continued to demonstrate clinically meaningful and durable responses with a a median progression-free survival of 6.9 months and median overall survival of 13.4 months in the overall trial population, noted October 23, 2023."
-IBRX,BCG-Unresponsive Bladder Cancer Carcinoma,BLA Filing,2023-10-23 00:00:00,"BLA Resubmitted to the FDA, noted October 23, 2023."
-BOLT,"HER2-Expressing Solid Tumors, gastric cancer, including gastroesophageal junction cancer",Phase 2,2023-10-23 00:00:00,"Phase 2 updated safety data presented at ESMO supports the selection of 20 mg/kg q2w as the recommended Phase 2 dose (RP2D), noted October 23, 2023."
-STRO,Ovarian and Endometrial Cancer,Phase 1,2023-10-23 00:00:00,"Additional Phase 1 data reported that a confirmed partial response (PR) was seen in 29% of patients, and the Disease Control Rate (DCR) was 86%, noted October 23, 2023."
-REGN,Stage II to IV resectable cutaneous squamous cell carcinoma (CSCC),Phase 2,2023-10-23 00:00:00,"Phase 2 data from ESMO 23 reported a 89% event-free survival rate at one year, and no disease recurrence among patients who achieved a pCR (n=40), noted October 23, 2023."
-PDSB,Head and neck cancer,Phase 2,2023-10-23 00:00:00,"Phase 2 data presented at ESMO reported that the combination of PDS0101 and KEYTRUDA resulted in increased polyfunctionality reflected in T cells expressing 5 or more cytokines, noted October 23, 2023."
-ORIC,Tumors - EGFR/HER2 Exon 20 Inhibitor,Phase 1b,2023-10-23 00:00:00,"Phase 1b initial data presented at ESMO reported responses observed in 2 of 3 EGFR exon 20 patients previously treated with amivantamab (67% ORR), including a confirmed complete response, note October 23, 2023."
-GLTO,Non-small cell lung cancer (NSCLC),Phase 2a,2023-10-23 00:00:00,"Phase 2a data reported that the objective tumor responses (defined as partial responses per RECIST criteria 1.1) were observed in three of five patients (60%) who received GB1211 for at least three weeks, noted October 23, 2023"
-RHHBY,Non-small cell lung cancer (NSCLC),Phase 2a,2023-10-23 00:00:00,"Phase 2a data reported that the objective tumor responses (defined as partial responses per RECIST criteria 1.1) were observed in three of five patients (60%) who received GB1211 for at least three weeks, noted October 23, 2023"
-BMRN,Children under age 5 with Achondroplasia,Approved,2023-10-23 00:00:00,"Approved October 23, 2023."
-MRK,"Personalized cancer vaccine, high-risk melanoma",Phase 2,2023-10-23 00:00:00,"Phase 2 additional data presented at ESMO reported that local recurrence was more common in MRs; MNRs had more distant events. This trend was supported by stronger separation in DMFS vs RFS between MRs and MNRs, noted October 23, 2023."
-QNRX,Netherton Syndrome (NS),Phase 1,2023-10-24 00:00:00,"Phase 1 data from 6 subjects demonstrated well defined efficacy signals across a number of study endpoints, noted October 24, 2023."
-IMTX,Solid tumors,Phase 1b,2023-10-24 00:00:00,"FDA Granted RMAT on October 24, 2023."
-AXSM,Agitation in patients with Alzheimer’s disease (AD),Phase 3,2023-10-24 00:00:00,"Phase 3 results shared at the CTAD demonstrated rapid and sustained clinical response in patients with ADA during the open-label AXS-05 treatment. During the placebo-controlled randomized withdrawal phase, AXS-05 statistically significantly delayed the time to relapse of agitation symptoms as compared to placebo, noted October 24, 2023."
-MRNA,COVID-19,Phase 3,2023-10-24 00:00:00,"Phase 3 trial of mRNA-1083 in adults 50 years initiated, noted October 24, 2023."
-BMY,Progressive pulmonary fibrosis (PPF),Phase 2,2023-10-24 00:00:00,"Breakthrough Therapy Designation (BTD) granted by FDA on October 24, 2023."
-RNAZ,Metastatic solid tumors,Phase 1a,2023-10-24 00:00:00,"Phase 0 preliminary data showed that radioactivity consistent with accumulation of TTX-MC138 was detected by noninvasive imaging in the regions of the metastatic lesions previously identified by fluorodeoxyglucose (FDG)/positron emission tomography (PET) (FDG/PET), noted October 24, 2023."
-IMMP,Solid tumors,Phase 1,2023-10-24 00:00:00,"Phase 1 additional efficacy and tolerability data reported at ESMO showed strong 71.4% Overall Response Rate, 90.5% Disease Control Rate, 10.1-month median Progression Free Survival (PFS), and median Overall Survival (OS) that has not been reached, despite 81% of patients having low or negative PD-L1 expression, noted October 24, 2023."
-EFTR,relapsed/refractory Acute Myeloid Leukemia (AML),Phase 1,2023-10-24 00:00:00,"Phase 1 initiated, noted October 24, 2023."
-JNJ,Non- Small Cell Lung Cancer,Phase 3,2023-10-24 00:00:00,"Phase 3 data presented at ESMO reported that PFS was significantly improved with ami-chemo (HR, 0.48; 95% CI, 0.36–0.64) and ami-laz-chemo (HR, 0.44; 95% CI, 0.35–0.56) vs chemo (median PFS, 6.3 and 8.3 vs 4.2 mo), noted October 24, 2023."
-JNJ,GFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer,Phase 3,2023-10-24 00:00:00,"Phase 3 data presented at ESMO reported ami+laz showed a 30% reduction in the risk for disease progression or death vs osi, with median PFS of 23.7 mo, and an ORR of 86%, noted October 24, 2023."
-JNJ,High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC),Phase 2b,2023-10-24 00:00:00,"Phase 2b data presented at ESMO reported that centrally confirmed CR was achieved in 23/30 pts, noted October 24, 2023."
-INMB,Neuroinflammation caused by Alzheimer’s disease,Phase 2,2023-10-24 00:00:00,"Phase 2 presentation at CTAD reported that XPro was associated with dose-dependent improvement in neurology-related proteins, noted October 24, 2023."
-JNJ,Non-small cell lung cancer,Phase 3,2023-10-24 00:00:00,"Phase 3 data presented at ESMO reported that the median PFS was 11.4 months and the ORR was 73%, noted October 24, 2023."
-MGTX,Xerostomia,Phase 1,2023-10-24 00:00:00,"Phase 1 OLE data presented at ESGCT showed that dosing was safe and well-tolerated at all dose levels, with no treatment-related serious adverse events or dose limiting toxicity, noted October 24, 2023."
-FRLN,Gaucher disease,Phase 1/2,2023-10-25 00:00:00,"Phase 1/2 results shared at the ESGCT reported no infusion reactions and no serious adverse events, noted October 25, 2023."
-GSK,"Respiratory syncytial virus (RSV) disease, Vaccine",Phase 3,2023-10-25 00:00:00,"Phase 3 trial met its co-endpoint, eliciting an immune response, noted October 25, 2023."
-SAVA,Mild-to-Moderate Alzheimer's Disease,Phase 3,2023-10-25 00:00:00,"Phase 3 MRI data suggested that simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities, or ARIA. MRIs were all analyzed for ARIA by board-certified neuroradiologists, noted October 25, 2023."
-BIIB,Mild Alzheimer's disease,Phase 1b,2023-10-25 00:00:00,"Phase 1b data presented at CTAD showed favorable trends reported for the high-dose groups on multiple measures of cognition and function, noted October 25, 2023."
-ALNY,Alzheimer's Disease and Cerebral Amyloid Angiopathy,Phase 1,2023-10-25 00:00:00,"Phase 1 achieve sustained pharmacodynamic activity up to 10 months after administration, noted October 25, 2023."
-BBIO,Gastric Cancer / Gastroesophageal junction adenocarcinoma,Phase 2a,2023-10-25 00:00:00,"Phase 2a data presented at ESMO showed that infigratinib was generally well tolerated with a manageable safety profile, noted October 25, 2023."
-LIAN,Gastric Cancer / Gastroesophageal junction adenocarcinoma,Phase 2a,2023-10-25 00:00:00,"Phase 2a data presented at ESMO showed that infigratinib was generally well tolerated with a manageable safety profile, noted October 25, 2023."
-BIIB,Alzheimer’s disease,Phase 3,2023-10-25 00:00:00,"Phase 3 presentation at CTAD reported a 14% greater amyloid plaque removal than biweekly IV administration as suggested in a preliminary analysis using amyloid PET at 6 months of treatment, noted October 25, 2023."
-BIVI,Alzheimer’s disease,Phase 3,2023-10-25 00:00:00,"Phase 3 presented at CTAD showed statistically significant population changes from baseline were observed for all primary and secondary cognitive and functional assessments measured: ADAS-Cog12, ADCS-CGIC, MMSE, CDR, CDR-SB, ADCOMS, and ADL, noted October 25, 2023."
-BMY,Ulcerative colitis (UC),Phase 2,2023-10-26 00:00:00,"Phase 2 trial was unsuccessful, noted October 26, 2023."
-PFE,"Influenza and COVID-19, Omicron BA.4/BA.5-adapted bivalent",Phase 1/2,2023-10-26 00:00:00,"Phase 1/2 data demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains, noted October 26, 2023."
-ORTX,Mucopolysaccharidosis type I (MPS-I),Phase 1,2023-10-26 00:00:00,"PoC data presented at ESGCT resulted in improvement 62.5% of patients or stabilization 37.5% of patients of corneal clouding at the time of last follow-up ranging from 3.14-4.58 years compared to baseline measured prior to administration with OTL-203, noted October 26, 2023."
-BNTX,"Influenza and COVID-19, Omicron BA.4/BA.5-adapted bivalent",Phase 1/2,2023-10-26 00:00:00,"Phase 1/2 data demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains, noted October 26, 2023."
-BCRX,"Paroxysmal nocturnal hemoglobinuria (PNH), Healthy Volunteers",Phase 1,2023-10-26 00:00:00,"Phase 1 PoC trial with PNHl initiated, noted October 26, 2023."
-CPRX,Duchenne Muscular Dystrophy (DMD),Approved,2023-10-26 00:00:00,"Approved October 26, 2023."
-EWTX,Duchenne Muscular Dystrophy (DMD),Phase 2,2023-10-26 00:00:00,"Phase 2 cohort in boys initiated, October 26, 2023."
-ASND,Solid tumors,Phase 1/2,2023-10-26 00:00:00,"Phase 1/2 updated data presented at ESMO resulted in clinical responses demonstrated as monotherapy or in combination with checkpoint inhibitor, noted October 26, 2023."
-EWTX,Duchenne Muscular Dystrophy (DMD),Approved,2023-10-26 00:00:00,"Approved October 26, 2023."
-REGN,Genetic hearing loss,Phase 1/2,2023-10-26 00:00:00,"Phase 1/2 data reported that one patient experienced improvements in auditory responses through week 6 compared to baseline, noted October 26, 2023."
-EWTX,dystrophinopathies including Duchenne Muscular Dystrophy in children and adolescent boys,Phase 2,2023-10-26 00:00:00,"Phase 2 initiated, noted October 26, 2023."
-ABOS,Alzheimer’s disease (AD),Phase 1,2023-10-27 00:00:00,"Additional Phase 1 results shared at CTAD reported that statistically significant amyloid plaque reduction that was comparable to approved and in-review therapies at similar time points, was observed in higher dose cohorts, noted October 27, 2023"
-ALEC,Frontotemporal Dementia,Phase 3,2023-10-27 00:00:00,"Phase 3 target enrollment achieved, noted October 27, 2023."
-CGTX,Early Alzheimer's disease,Phase 2,2023-10-27 00:00:00,"Phase 2 data points to a role for the sigma-2 (σ-2) receptor in regulating key ""housekeeping"" processes such as autophagy that are impaired in Alzheimer's and other neurodegenerative diseases, noted October 27, 2023."
-RHHBY,Macular edema due to RVO,Approved,2023-10-27 00:00:00,"Approved October 27, 2023."
-CHRS,Nasopharyngeal carcinoma (NPC),Approved,2023-10-27 00:00:00,"FDA Approval on October 27, 202"
-VYNE,Vitiligo,Phase 1b,2023-10-30 00:00:00,"Phase 1b clinical proof-of-concept achieved with statistically significant dose dependent reduction in F-VASI score from baseline for the VYN201 1.0% and 2.0% cohorts compared to the 0.5% cohort, noted October 30, 2023."
-DCPH,Tenosynovial Giant Cell tumor,Phase 3,2023-10-30 00:00:00,"Phase 3 study met primary endpoint with objective response rate (ORR) at week 25 of 40% compared to 0% for placebo. The study also met all key secondary endpoints at Week 25 compared to placebo, noted October 30, 2023."
-RVPH,Schizophrenia,Phase 3,2023-10-30 00:00:00,"Phase 3 trial met primary endpoint, noted October 30, 2023."
-PHAT,H. pylori,Approved,2023-10-30 00:00:00,"Prior Approval Supplement (PAS) for the reformulation of vonoprazan tablets approved October 30, 2023."
-FDMT,Fabry Disease,Phase 1/2,2023-10-30 00:00:00,"Phase 1/2 FDA meeting to lift clinical hold and continue trial developments, noted October 30, 2023."
-CHRS,1L Metastatic Nasopharyngeal Carcinoma,Approved,2023-10-30 00:00:00,"Approved October 27, 2023."
-SLS,"Hematologic malignancies, acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and lymphoma",Phase 2a,2023-10-30 00:00:00,"FDA granted fast track designation, noted October 30, 2023."
-APTO,Acute myeloid leukemia (AML),Phase 1/2,2023-10-30 00:00:00,"Phase 1/2 data demonstrated 44% ORR with TUS/VEN in Difficult-to-Treat VEN Failure R/R AML Patients, noted October 30, 2023."
-CVM,Head and Neck cancer,Phase 3,2023-10-30 00:00:00,"Phase 3 data finalized target population data resulted in risk of death cut in half at five years versus the control, 28.6% absolute 5-year overall survival benefit versus control, 0.349 hazard ratio vs control , noted October 30, 2023."
-RHHBY,Duchenne muscular dystrophy,Phase 3,2023-10-30 00:00:00,"Phase 3 trial results showed that participants treated with ELEVIDYS (delandistrogene moxeparvovec-rokl) showed an increase on the North Star Ambulatory Assessment, a measure of motor function, compared to placebo-treated patients at 52 weeks, although the primary endpoint was not met, noted October 30, 2023."
-SRPT,Duchenne muscular dystrophy,Phase 3,2023-10-30 00:00:00,"Phase 3 trial results showed that participants treated with ELEVIDYS (delandistrogene moxeparvovec-rokl) showed an increase on the North Star Ambulatory Assessment, a measure of motor function, compared to placebo-treated patients at 52 weeks, although the primary endpoint was not met, noted October 30, 2023."
-LIAN,Demodex blepharitis,Phase 3,2023-10-30 00:00:00,"Phase 3 results demonstrated statistically significant mite eradication in patients treated compared to vehicle, noted October 30, 2023."
-ANVS,Alzheimer’s disease (AD),Phase 2/3,2023-10-30 00:00:00,"Phase 2/3 trial DSMB feedback resulted in no drug-related SAEs, each AE < 5% and a very low dropout rate of 4.7%, noted October 30, 2023."
-GOVX,COVID-19 in immunocompromised patients,Phase 2,2023-10-30 00:00:00,"Phase 2 site expansion commenced, noted Otober 30, 2023."
-CNTA,Hemophilia B,Phase 2b,2023-10-31 00:00:00,"Phase 2b initiated, noted October 31, 2023."
-GRTX,Pancreatic Cancer,Phase 2b,2023-10-31 00:00:00,"Phase 2b did not pass futility analysis, so trial halted to preserve cash, noted October 31, 2023."
-GRTX,Non-Small Cell Lung Cancer (NSCLC),Phase 1/2,2023-10-31 00:00:00,"Phase 1/2 halted after GRECO-2 failed futility analysis, so trial halted to preserve cash, noted October 31, 2023."
-CYBN,Major Depressive Disorder (MDD) and Alcohol use disorder (AUD),Phase 1/2,2023-10-31 00:00:00,"Phase 1/2a topline data reported that the reduction in major depressive disorder (""MDD"") symptoms, defined as change from baseline in MADRS total score, was superior in participants assigned to CYB003 compared to the participants who received placebo by 14.08 points, noted October 31, 2023."
-REGN,Non-small cell lung cancer (NSCLC),Phase 2,2023-10-31 00:00:00,"Phase 2 preliminary efficacy data reported a 100% Disease Control Rate (DCR), noted October 31, 2023."
-MAIA,Non-small cell lung cancer (NSCLC),Phase 2,2023-10-31 00:00:00,"Phase 2 preliminary efficacy data reported a 100% Disease Control Rate (DCR), noted October 31, 2023."
-AMGN,Chronic spontaneous urticaria,Phase 2b,2023-10-31 00:00:00,"Phase 2b trial did not meet its primary endpoint, noted October 31, 2023."
-INDP,Advanced/metastatic solid tumors,Phase 1,2023-10-31 00:00:00,"Phase 1 data abstract to be presented at SITC on November 4, 2023 noted that each of the first cohort participants experienced transient activation of biomarkers associated with innate and/or adaptive immune responses, and generally expected transient adverse events, noted October 31, 2024."
-AMGN,Moderate to severe genital psoriasis,Phase 3,2023-10-31 00:00:00,"Phase 3 data presented that treated patients across subgroups experienced greater improvement in genital psoriasis and genital itch at week 16 compared to placebo, noted October 31, 2023."
-EVAX,Metastatic Melanoma,Phase 2b,2023-10-31 00:00:00,"Phase 2b data presented at SITC reported that a pronounced and ongoing tumor reduction was observed in a patient with progressive disease, noted October 31, 2023."
-NVS,Hidradenitis Suppurativa (HS),Approved,2023-10-31 00:00:00,"Approved October 31, 2023."
-MRK,Metastatic Melanoma,Phase 2b,2023-10-31 00:00:00,"Phase 2b data presented at SITC reported that a pronounced and ongoing tumor reduction was observed in a patient with progressive disease, noted October 31, 2023."
-KTRA,Glioblastoma (GBM),Phase 2/3,2023-10-31 00:00:00,"Phase 2/3 data reported that it did not perform better than the current standards of care in glioblastoma, noted October 31, 2023."
-PFE,Glioblastoma (GBM),Phase 2/3,2023-10-31 00:00:00,"Phase 2/3 data reported that it did not perform better than the current standards of care in glioblastoma, noted October 31, 2023."
-BHVN,Glioblastoma (GBM),Phase 2/3,2023-10-31 00:00:00,"Phase 2/3 data reported that it did not perform better than the current standards of care in glioblastoma, noted October 31, 2023."
-KZIA,Glioblastoma (GBM),Phase 2/3,2023-10-31 00:00:00,"Phase 2/3 data reported that it did not perform better than the current standards of care in glioblastoma, noted October 31, 2023."
-AMGN,Metastatic castrate-resistant prostate cancer (mCRPC),Phase 1b,2023-10-31 00:00:00,"Phase 1b initial data reported that efficacy was greater at higher doses (doses ≥0.75 mg target dose) where PSA50 was 59% (n=44) and RECIST objective response rate was 41% (n=37). The safety profile was clinically manageable, with CRS that was generally low grade and primarily in cycle 1, noted October 31, 2023."
-MNPR,Soft tissue sarcoma,Phase 1b,2023-11-01 00:00:00,"t, as well, which may result in further tumor size reduction, noted August 8, 2023. Phase 1b data showed that 9 out of the 14 patients have had stable disease (SD, as defined by RECIST 1.1 criteria) after camsirubicin treatment., noted November 1, 2023."
-MRK,Biliary Tract Cancer,Approved,2023-11-01 00:00:00,"Approved November 1, 2023."
-MRK,Renal cell carcinoma (RCC),Phase 3,2023-11-01 00:00:00,"Phase 3 trial met its primary endpoint, noted November 1, 2023."
-TNXP,Major depressive disorder (MDD),Phase 2,2023-11-01 00:00:00,"Phase 2 topline data reported that the trial did not meet its primary endpoint, noted November 1, 2023."
-DARE,Female Sexual Arousal Disorder (FSAD),Phase 2b,2023-11-01 00:00:00,"Phase 2b exploratory data reported that trial achieved statistical significance and clinically meaningful improvement in Phase 2b co-primary endpoint assessing arousal sensation, and statistical significance in items from Phase 2b co-primary endpoint scale evaluating concern related to difficulties with sexual arousal in subset analyses, noted November 1, 2023."
-SLN,Cardiovascular diseases,Phase 1,2023-11-01 00:00:00,"Phase 1 data showed very significant and durable reductions in lipoprotein(a) of up to 99%. Lp(a) levels remained around 90% lower than baseline at study endpoint, noted November 1, 2023."
-CLSD,Neovascular age-related macular degeneration (wet AMD),Phase 2b,2023-11-01 00:00:00,"Phase 2b recruitment completed, noted November 1, 2023."
-FDMT,Cystic fibrosis,Phase 2,2023-11-01 00:00:00,"Phase 2 Dose Expansion interim data presented at the North American Cystic Fibrosis Conference showed that it was generally well tolerated with no inflammation in any lung biopsy across Cohorts 1 and 2 (1E15 & 2E15 vg; n=7) with up to 17 months follow-up November 1, 2023."
-PHAT,Erosive esophagitis / Gastroesophageal reflux disease (GERD),Approved,2023-11-01 00:00:00,"FDA Approved on November 1, 2023."
-RANI,Neuroendocrine tumors (NETs) and acromegaly,Phase 1,2023-11-01 00:00:00,"Program discontinued, noted November 1, 2023."
-RANI,Rheumatoid arthritis,Phase 1,2023-11-01 00:00:00,"Program paused, noted November 1, 2023."
-INVA,Uncomplicated gonorrhea,Phase 3,2023-11-01 00:00:00,"Phase 3 data met the primary endpoint when compared against the combination of injectable ceftriaxone and oral azithromycin, noted November 1, 2023."
-CCCC,Synovial sarcoma,Phase 1,2023-11-01 00:00:00,"Phase 1 deprioritized due to insufficient single agent efficacy, despite high levels of BRD9 degradation, noted November 1, 2023."
-KROS,Myelodysplastic syndromes (MDS),Phase 2,2023-11-02 00:00:00,"Phase 2 data from ASH abstract reported that the median treatment duration was 166 days (range 6 to 649). Most participants (89.8%) had at least 1 treatment-emergent adverse event (TEAE), and 32.2% had TEAEs considered treatment-related, noted November 2, 2023."
-JSPR,Acute myeloid leukemia/Myelodysplastic syndrome (AML/MDS),Phase 1,2023-11-02 00:00:00,"Phase 1 results from abstracts reported that 10 of 13 AML in CR and 14 of 16 MDS subjects had MRD at pre-HCT screening assessed by cytogenetics, flow cytometry, and/or next generation sequencing, noted November 2, 2023."
-IRON,Myelofibrosis (MF) patients with anemia,Phase 1/2,2023-11-02 00:00:00,"Phase 1b/2 data from abstracts reported dose-dependent reductions in serum hepcidin-25 and increases in serum iron levels, noted November 2, 2023."
-IRON,Erythropoietic Protoporphyria (EPP),Phase 2,2023-11-02 00:00:00,"Phase 2 data from abstract reported that treatment with bitopertin resulted in mean (SD) decreases in PPIX of -39% by Day 43, noted November 2, 2023."
-IPSC,Lymphoma or Indolent Lymphoma,Phase 1,2023-11-02 00:00:00,"Phase 1 data from ASH abstract reported that one patient achieved a complete response that is ongoing as of five months following their first CNTY-101 infusion, noted November 2, 2023."
-INAB,Allogeneic hematopoietic stem cell transplantation (HSCT),Phase 1,2023-11-02 00:00:00,"Phase 1 data from ASH abstract reported that treatment emergent AE's included transient WBC and ANC decreased (100% each), platelet count decreased and anemia (88.9% each) and maculopapular rash, hypomagnesemia and blood creatine increased (55.6% each), noted November 2, 2023."
-HARP,Multiple myeloma,Phase 1,2023-11-02 00:00:00,"Phase 1 data from ASH abstract reported that among the 12mg and 24mg cohorts, 55% (22/40) of efficacy-evaluable pts currently have had a confirmed response (PR or better) and among pts with a response, 73% (16/22) have had a confirmed response of VGPR or better, noted November 2, 2023."
-NTLA,Transthyretin amyloidosis (ATTR),Phase 1,2023-11-02 00:00:00,"Phase 1 updated data from over 60 patients showed consistent, deep and durable serum TTR reduction achieved with a single dose of NTLA-2001, including in 29 patients who have now reached 12 months or more of follow-up, noted November 2, 2023."
-OTLK,Wet age-related macular degeneration (wet AMD),BLA Filing,2023-11-02 00:00:00,"The FDA informed the company that an additional adequate and well-controlled clinical trial would be required for the approval of ONS-5010 for wet AMD. Resubmission of the ONS-5010 BLA as early year end 2024, noted November 2, 2023."
-REGN,Transthyretin amyloidosis (ATTR),Phase 1,2023-11-02 00:00:00,"Phase 1 updated data from over 60 patients showed consistent, deep and durable serum TTR reduction achieved with a single dose of NTLA-2001, including in 29 patients who have now reached 12 months or more of follow-up, noted November 2, 2023."
-ACXP,C. difficile Infection,Phase 2b,2023-11-02 00:00:00,"Phase 2a and 2b data reported an observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96%, noted November 2, 2023."
-MEIP,B-Cell Malignancies or Acute Myeloid Leukemia (AML),Phase 1,2023-11-02 00:00:00,"Phase 1 data from ASH abstract reported that at 200 mg, 5 of 10 AML pts (50%) had stable disease, noted November 2, 2023."
-MOLN,Acute myeloid leukemia (AML),Phase 1,2023-11-02 00:00:00,"Phase 1 data from ASH abstract reported that one of the two patients evaluable for MP0533 antitumor activity in the third treatment cohort achieved a response, noted November 2, 2023."
-EYEN,Mydriasis (office-based pupil dilation),Approved,2023-11-02 00:00:00,"FDA supplemental approval on November 1, 2023."
-ALPN,"Lupus nephritis, IgA nephropathy",Phase 1/2,2023-11-02 00:00:00,"Phase 1b/2a data presented at ASN reported that treatment reduced UPCR by greater than 50% in IgA nephropathy, noted November 2, 2023."
-NRIX,B-cell malignancies / graft-versus-host disease,Phase 1a,2023-11-02 00:00:00,"Phase 1a data from ASH abstract reported that of three evaluable patients with CLL receiving the lowest dose of 50 mg, early signs of clinical activity were observed including one confirmed partial response and 2 patients with stable disease, noted November 2, 2023."
-MTEM,Solid tumors,Phase 1,2023-11-02 00:00:00,"Phase 1 dosing initiated, noted November 2, 2023."
-OMER,Paroxysmal nocturnal hemoglobinuria (PNH),Phase 1b,2023-11-02 00:00:00,"Phase 1b data from ASH abstract reported that mean Hgb increased from baseline by 3.1 g/dL at 4 weeks, and by 9.5 g/dL at the latest timepoint of 24 weeks, noted November 2, 2023."
-NRIX,"B-cell malignancies, chronic lymphocytic leukemia (CLL)",Phase 1b,2023-11-02 00:00:00,"Phase 1b data from ASH abstract reported that 9 PRs/PR with rebound lymphocytosis; additionally, 11 patients had SD at the time of data cut-off and 4 had PD, noted November 2, 2023."
-SONN,Healthy volunteers,Phase 1,2023-11-02 00:00:00,"Phase 1 interim analysis presented at CTAD reported that in single doses up to 300 ng/kg and in patients with advanced cancer in repeated doses up to at least 540 ng/kg. Incorporation of a desensitizing first dose at 150-300 ng/kg and dosing every 3 weeks has been implemented to capitalize on the potential benefits of tachyphylaxis with rhIL-12, noted November 2, 2023."
-FHTX,Synovial sarcoma,Phase 1,2023-11-02 00:00:00,"Phase 1 preliminary results shared at the Connective Tissue Oncology Society Annual Meeting reported that FHD-609 treatment led to dose-dependent BRD9 degradation in tumor tissue, noted November 2, 2023."
-KRON,Solid tumors,Phase 1/2,2023-11-02 00:00:00,"Phase 2 initial data presented at Connective Tissue Oncology Society reported that treatment demonstrated on-mechanism, single agent anti-tumor activity and a manageable safety profile in heavily pre-treated patients with transcriptionally addicted solid tumors, noted November 2, 2023."
-OPK,Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) - Stage 5,Phase 2,2023-11-02 00:00:00,"Phase 2 data presented at ASH indicated that early, sustained and effective treatment of secondary hyperparathyroidism (SHPT) with RAYALDEE is associated with significantly slower progression CKD in pre-dialysis patients, noted November 2, 2023."
-MLYS,Hypertension,Phase 2,2023-11-02 00:00:00,"Phase 2 data to be presented ASN further supports obesity-associated dysregulated aldosterone as an endotype predictive of enhanced response, noted November 2, 2023."
-TCRX,Hematologic malignancies,Phase 1,2023-11-02 00:00:00,"Phase 1 data from abstract reported that the safety analysis found expected post-HCT adverse events similar in treatment and control arms. Incidence of graft-versus-host disease (GvHD) was similar in control (3 events) and treatment arms, noted November 2, 2023."
-LLY,Atopic Dermatitis,CRL,2023-11-02 00:00:00,"CRL received in the US, noted November 2, 2023."
-ELDN,Kidney transplant rejection,Phase 2,2023-11-02 00:00:00,"Phase 2 data from 11 participants demonstrates tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated, noted November 2, 2023."
-SDGR,B-cell lymphoma,Phase 1,2023-11-02 00:00:00,"Phase 1 data from ASH abstract reported that treatment showed excellent potency in the biochemical assay and strong anti-proliferative effects on ABC-DLBCL cells, noted November 2, 2023."
-PFE,Hemophilia A or B,Phase 3,2023-11-02 00:00:00,"Phase 3 data from ASH abstract reported that OD group reported 12 (36.4%) adverse events (AEs) during ATP vs 9 (24.3%) in OP whereas the RP group reported 62 (74.7%) AEs in ATP vs 20 (22.0%) in OP, noted November 2, 2023."
-GBT,Sickle cell disease (SCD),Phase 2/3,2023-11-02 00:00:00,"Phase 2/3 data from ASH abstract reported that safety data showed GBT021601 was well tolerated. For 27 patients with VOC at baseline, the baseline annualized VOC rate was 2.30, noted November 2, 2023."
-PFE,Sickle cell disease (SCD),Phase 2/3,2023-11-02 00:00:00,"Phase 2/3 data from ASH abstract reported that safety data showed GBT021601 was well tolerated. For 27 patients with VOC at baseline, the baseline annualized VOC rate was 2.30, noted November 2, 2023."
-PTGX,Polycythemia vera,Phase 2,2023-11-02 00:00:00,"Phase 2 data from abstract reported that treatment resulted in consistent maintenance of hematocrit below 45% and an overall decrease in erythrocyte counts, noted November 2, 2023."
-STTK,Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS),Phase 1,2023-11-02 00:00:00,"Phase 1 data from ASH abstract reported that in 4 evaluable pts with UnTx TP53m-MDS, the ORs were 1 complete remission (CR), 1 marrow CR, and 2 stable disease. 2 of them proceeded to allo-HCT, noted November 2, 2023."
-ORIC,Multiple myeloma,Phase 1b,2023-11-02 00:00:00,"Phase 1b data from ASH abstract reported that ORIC-533 was very well tolerated, with 5 patients experiencing a total of 10 treatment-related adverse events (TRAEs), noted November 2, 2023."
-MOLN,Solid Tumors,Phase 1,2023-11-03 00:00:00,"Phase 1 data presented at SITC continues to demonstrate tumor-localized CD40 activation, leading to elevated immune activity in the tumor microenvironment, noted November 3, 202"
-AZN,Chronic Kidney Disease (CKD),Phase 2b,2023-11-03 00:00:00,"Phase 2b showed statistically significant and clinically meaningful reductions in urinary albumin-to-creatinine ratio (UACR), noted November 3, 2023."
-TVTX,Focal segmental glomerulosclerosis (FSGS),Phase 3,2023-11-03 00:00:00,"Phase 3 presentations at ASN showed that sparsentan delivered a clinically meaningful benefit at 108 weeks with significant proteinuria reduction, higher rates of partial and complete remission, and lower rates of end-stage kidney disease, noted November 3, 2023."
-TVTX,IgA nephropathy (IgAN),Phase 3,2023-11-03 00:00:00,"Additional Phase 3 data presented at ASN showed one of the slowest rates of kidney function decline in IgAN trials, consistent treatment effects across baseline eGFR and proteinuria, and higher rates of complete remission compared to maximally tolerated dose of irbesartan through 110 weeks of treatment, noted November 3, 2023."
-IPHA,Mycosis Fungoides,Phase 2,2023-11-03 00:00:00,"Phase 2 data from ASH abstract reported that the global confirmed ORR was 37.5% including 2 CRs, with a median time to response of 2.8 months, noted November 3, 2023."
-HOWL,Solid Tumors,Phase 1b,2023-11-03 00:00:00,"Phase 1/1b preliminary data provided compelling early evidence of dose-dependent biomarker and antitumor activity in patients, including two patients with ongoing unconfirmed partial responses (uPR) in the highest dose tested to date, cohort 4 (12 mg), noted November 3, 2023."
-AUPH,Lupus Nephritis,Phase 3,2023-11-03 00:00:00,"Phase 3 data from ASN reported that treated patients in the overall AURORA 2 cohort maintained stable renal function over the last two years of the study, as measured by eGFR analysis and experienced numerically greater mean reductions in urine protein creatinine ratio (UPCR), compared to patients in the control arm, noted November 3, 2023."
-CADL,Pancreatic Cancer,Phase 2,2023-11-03 00:00:00,"Phase 2 initial overall survival and immunological biomarker data presented at SITC revealed notable improvements in patients with borderline resectable pancreatic ductal adenorcarcinoma (PDAC) after experimental treatment with CAN-2409, noted November 3, 2023."
-PSTV,Leptomeningeal metastases (LM),Phase 1/2,2023-11-03 00:00:00,"FDA granted Orphan Drug Designation (ODD), noted November 3, 2023."
-CUE,HPV16+ head and neck cancer,Phase 1,2023-11-03 00:00:00,"Phase 1 data shared at SITC showed an overall response rate (ORR) of 47% and disease control rate (DCR) of 65% in first line (1L) HNSCC patients treated with CUE-101 and pembrolizumab. ORR of 56% in patients with low expression of PD-L1 in the tumor, noted November 3, 2023."
-INKT,Solid Tumors,Phase 1,2023-11-03 00:00:00,"Phase 1 trial of agenT-797 alone or in combination showed durable clinical benefit, including: Clinical response in MSI-high 3L gastric cancer patient after failure on pembrolizumab and nivolumab/FOLFOX. Long-term disease stabilization (n=10), including in testicular cancer (SD 9 months) and anti-PD-1 relapsed/refractory non-small-cell lung cancer (SD > 10 months). Tolerable safety profile with no dose-limiting toxicities and no grade >3 neurotoxicity or cytokine release syndrome, noted November 3, 2023."
-RAPT,Advanced Cancer,Phase 1/2,2023-11-03 00:00:00,"Phase 1/2 update SITC showed a confirmed objective response rate (ORR) of 40% in PD-L1 positive (TPS ≥1%) patients with no prior checkpoint inhibitor therapy (CPI). Median progression-free survival (PFS) of 6.3 months in PD-L1 positive patients at time of data cut off, noted November 3, 2023"
-XAIR,Solid tumors,Phase 1,2023-11-03 00:00:00,"Phase 1 data presented at SITC demonstrated early clinical proof of concept, noted November 3, 2023."
-XLO,Solid Tumors,Phase 1/2,2023-11-03 00:00:00,"Phase 1/2 trial data presented at SITC showed initial evidence of dose-dependent disease control rate with 50% disease control rate at higher doses (≥2.8 mg/kg) and 31% disease control rate across all dose levels in a range of solid tumor types, including cold tumors, noted November 3, 2023."
-CGEM,Solid tumors,Phase 1,2023-11-03 00:00:00,"Phase 1 Initial clinical biomarker data demonstrated that CLN-619 increases MICA expression on the tumor cell surface, consistent with previously reported preclinical data and supporting the proposed mechanism of action, noted November 3, 2023."
-HOOK,HPV16+ Squamous cell head and neck cancers (HNSCC),Phase 1,2023-11-03 00:00:00,"Phase 1 biomarker results demonstrated a robust increase in tumor-specific CD8+ T cells in all evaluable patients with HPV16+ head and neck cancers, noted November 3, 2023. Randomized trial planned for 2024."
-IMMP,Non-small cell lung cancer; Head and neck cancer,Phase 2,2023-11-03 00:00:00,"Additional biomarker results shared at SITC showed statistically significant increases of Th1 biomarkers (IFN-gamma, CXCL-10), circulating immune cells (lymphocytes), and RNA levels of immune activating genes were observed and linked to improved clinical outcomes, noted November 3, 2023."
-SRRK,Solid Tumors,Phase 1,2023-11-03 00:00:00,"Phase 1 biomarker data presented at SITC showed promising anti-tumor activity in heavily pretreated clear cell renal cell carcinoma (ccRCC) patients. Objective response rate (ORR) of 21.4% and disease control rate of 57%, noted November 3, 2023."
-KA,Solid tumors,Phase 1/2,2023-11-03 00:00:00,"Phase 1/2 biomarker data to be presented at SITC, noted Noember 3 2023."
-FLGT,Various cancers,Phase 1/2,2023-11-03 00:00:00,"Phase 1/2 data reported that FID-007 may have anti-tumor activity in heavily pre-treated patients across various tumor types, and a subgroup analysis based on 7 patients for Head and Neck cancer and 4 patients for Ampullary/Pancreatic cancer showed 57% and 50% objective response rate, respectively, noted November 3, 2023."
-ELTX,Solid Tumors,Phase 1/2,2023-11-03 00:00:00,"Phase 1/2 data presented at SITC reported that 87% (20/23) had direct ex vivo mKRAS-specific T cell responses, and 100% (23/23) had in vitro stimulated responses, noted November 3, 2023."
-CUE,Wilms' Tumor (WT1)-expressing cancers,Phase 1,2023-11-03 00:00:00,"Phase 1 data presented at SITC demonstrated a 75%-80% DCR at the 4mg/kg and 2mg/kg doses respectively with two patients demonstrating tumor reductions of -30% and -29%, noted November 3, 2023."
-REGN,Various cancers,Phase 1,2023-11-04 00:00:00,"Phase 1 safety data reported that a total of 11 adverse events (including one serious adverse event not considered related to SNS-101) was reported in five patients, with no dose-limiting toxicities observed, noted November 4, 2023."
-SNSE,Various cancers,Phase 1,2023-11-04 00:00:00,"Phase 1 safety data reported that a total of 11 adverse events (including one serious adverse event not considered related to SNS-101) was reported in five patients, with no dose-limiting toxicities observed, noted November 4, 2023."
+ticker,disease,stage,date,catalyst,encoded_stage,label
+ARWR,Alpha-1 Liver Disease,Phase 2,2023-06-24 00:00:00,"Phase 2 data presented at EASL showed that at week 48, patients receiving 25, 100, or 200 mg fazirsiran achieved serum Z-AAT reductions of 74%, 89%, and 94%, respectively, versus an increase of 9% observed in patients receiving placebo, noted June 24, 2023.",10,LABEL_10
+AGIO,Sickle cell disease,Phase 2,2023-06-26 00:00:00,"Phase 2 portion met its primary endpoint of hemoglobin response for patients in both the 50 mg and 100 mg twice daily (BID) mitapivat arms, noted June 26, 2023",10,LABEL_10
+PHVS,Hereditary angioedema,Phase 1,2023-06-26 00:00:00,"Phase 1 clinical hold lifted by FDA on June 26, 2023.",6,LABEL_6
+FGEN,Idiopathic pulmonary fibrosis,Phase 3,2023-06-26 00:00:00,"Phase 3 study did not meet primary endpoints, noted June 26, 2023.",14,LABEL_14
+FGEN,Idiopathic pulmonary fibrosis (IPF),Phase 3,2023-06-26 00:00:00,"Phase 3 after ZEPHYRUS-1 results, company decided to discontinue this study, noted June 26, 2023.",14,LABEL_14
+BNTC,Oculopharyngeal muscular dystrophy (OPMD),Phase 1/2,2023-06-26 00:00:00,"Phase 1b/2a IND clearance on June 26, 2023.",7,LABEL_7
+AVTX,Non-Eosinophilic Asthma (NEA),Phase 2,2023-06-26 00:00:00,"Phase 2 did not meet the primary endpoint measured by reduction in asthma related events compared to placebo, noted June 26, 2023.",10,LABEL_10
+FUSN,Solid tumors,Phase 1,2023-06-26 00:00:00,"Phase 1 pre-administration data reported a favorable gain in tumor lesion uptake versus normal tissue, noted June 14, 2022.",6,LABEL_6
+CLVS,Ovarian Cancer - First-line maintenance treatment,PDUFA,2023-06-26 00:00:00,Company went bankrupt in 2022 not information disclosed about the PDUFA.,4,LABEL_4
+ACET,Non-Hodgkin’s lymphoma,Phase 1,2023-06-26 00:00:00,"Phase 1 safety and efficacy data demonstrated 71% overall response rate (ORR) and 63% complete response (CR) rate across all dose levels in patients with median 4 prior lines of therapy, a Six-month CR rate consistent with autologous CAR T cell therapy, noted June 26, 2023.",6,LABEL_6
+LLY,Obesity,Phase 2,2023-06-26 00:00:00,"Phase 2 24-week data met the primary endpoint for the efficacy estimand in participants living with obesity or overweight without diabetes, demonstrating a mean weight reduction up to 17.5%. In a secondary endpoint, retatrutide showed a mean weight reduction up to 24.2% at 48 weeks, noted June 26, 2023.",10,LABEL_10
+TERN,Obesity,Phase 1a,2023-06-26 00:00:00,"Preclinical data demonstrated the ability of TERN-601 to significantly improve glucose tolerance, suppress food intake and slow gastric emptying in transgenic mice, noted June 26, 2023",8,LABEL_8
+EWTX,Becker muscular dystrophy (BMD),Phase 1b,2023-06-26 00:00:00,"Phase 1b 12-month study supported the hypothesis that a reduction in contraction-induced muscle damage in muscular dystrophies, associated with administration, has the potential to preserve and improve muscle function while preventing disease progression in dystrophinopathies, noted June 26, 2023.",9,LABEL_9
+FUSN,Solid tumors,Phase 1,2023-06-26 00:00:00,"Phase 1 multi-dose safety and imaging data presented at SNMMI with Cold/Hot dosing regimen demonstrated potential to improve therapeutic index and safety profile, noted June 26, 2023.",6,LABEL_6
+ALDX,Chronic Cough,Phase 2,2023-06-27 00:00:00,"Phase 2 trial demonstrated statistically significant reduction in cough frequency following administration of ADX‑629 relative to placebo, noted June 27, 2023.",10,LABEL_10
+DRMA,Acne,Phase 2b,2023-06-27 00:00:00,"EoP2b FDA established key elements of the DMT310 Phase 3 clinical program and delineated a potential regulatory pathway for approval of DMT310, noted June 27, 2023.",13,LABEL_13
+NKTX,Acute myeloid leukemia / myelodysplastic syndromes,Phase 1,2023-06-27 00:00:00,"Additional Phase 1 data demonstrated that 4 of 6 patients achieved complete response (67% CR/CRi, 50% CR rate), and 2 CRs with MRD negativity 1 patient deepened response to MRD negative CRi with additional cycles, notedJune 27, 2023.",6,LABEL_6
+ETON,Methanol poisoning,CRL,2023-06-28 00:00:00,"CRL Announced on June 28, 2023.",2,LABEL_2
+PFE,Children - growth hormone deficiency,Approved,2023-06-28 00:00:00,"FDA Approved on June 28, 2023.",0,LABEL_0
+OPK,Children - growth hormone deficiency,Approved,2023-06-28 00:00:00,"FDA Approved on June 28, 2023.",0,LABEL_0
+GMAB,Follicular lymphoma (FL),Phase 1/2,2023-06-28 00:00:00,"Phase 1/2 FL cohort data reported an overall response rate (ORR) of 82% and that the median duration of response (DOR) was not reached, noted June 28, 2023.",7,LABEL_7
+ABBV,Follicular lymphoma (FL),Phase 1/2,2023-06-28 00:00:00,"Phase 1/2 FL cohort data reported an overall response rate (ORR) of 82% and that the median duration of response (DOR) was not reached, noted June 28, 2023.",7,LABEL_7
+KPTI,Myelofibrosis (MF) - previously treated,Phase 3,2023-06-28 00:00:00,"Phase 3 dosing commenced, noted June 28, 2023.",14,LABEL_14
+ALPMY,Severe vasomotor symptoms (VMS) due to menopause,Phase 3,2023-06-28 00:00:00,"Phase 3b data reported that the trial met its primary endpoint, noted June 28, 2023.",14,LABEL_14
+AVXL,Rett syndrome,Phase 2,2023-06-28 00:00:00,"Phase 2 long-term clinical study results demonstrated disease modifying effect of ANAVEX2-73 (blarcamesine) for adult patients with Rett syndrome, noted June 28, 2023.",10,LABEL_10
+RETA,Friedreich’s ataxia (FA),Approved,2023-06-28 00:00:00,"PAS approved June 28, 2023.",0,LABEL_0
+CGTX,Mild-to-Moderate Alzheimer's Disease,Phase 2,2023-06-28 00:00:00,"Phase 2 study met its primary endpoints for safety and tolerability and showed positive effects for CT1812-treated participants as measured via quantitative electroencephalogram (qEEG), noted June 28, 2023.",10,LABEL_10
+ALVO,Inflammatory diseases,CRL,2023-06-28 00:00:00,"Third CRL issued June 28, 2023. Resubmission planned.",2,LABEL_2
+TEVA,Inflammatory diseases,CRL,2023-06-28 00:00:00,"Third CRL issued June 28, 2023. Resubmission planned.",2,LABEL_2
+SLS,Malignant pleural mesothelioma (MPM),Phase 1,2023-06-28 00:00:00,"Phase 1 topline data reported that the median overall survival for patients who entered the study as Stage IV patients was 62.3 weeks, noted June 28, 2023.",6,LABEL_6
+CLRB,Various lymphoma,Phase 2,2023-06-28 00:00:00,"Phase 2 data from MM cohort reported an overall response rate (ORR) of 32%, a clinical benefit rate (CBR) of 75% and a disease control rate (DCR) of 85.7%, noted June 28, 2023.",10,LABEL_10
+BIIB,Friedreich’s ataxia (FA),Approved,2023-06-28 00:00:00,"PAS approved June 28, 2023.",0,LABEL_0
+PTCT,Huntington's disease,Phase 2,2023-06-28 00:00:00,"Phase 2 trial initiated March 30, 2022. Phase 2 trial data reported that treatment was well tolerated, with no treatment related serious adverse events and no adverse events leading to discontinuation, noted June 28, 2023.",10,LABEL_10
+EIGR,Chronic hepatitis delta virus (HDV),Phase 3,2023-06-29 00:00:00,"Phase 3 data presented at EASL showed that at week 48 the trial met its primary endpoint in both lonafarnib arms vs placebo, also 24-week post-treatment data demonstrated that both lonafarnib arms showed a statistically significant difference in composite response rate compared to placebo, noted June 24, 2023.",14,LABEL_14
+PTCT,Mitochondrial Epilepsy,Phase 2/3,2023-06-29 00:00:00,"Phase 2/3 data reported that trial did not meet the primary endpoint, noted June 29, 2023.",11,LABEL_11
+BMRN,Hemophilia A,Approved,2023-06-29 00:00:00,"Approved June 29, 2023.",0,LABEL_0
+BHC,Dry Eye Disease Associated With Meibomian Gland Dysfunction,Approved,2023-06-29 00:00:00,"Approved on May 18, 2023.",0,LABEL_0
+FBIO,Gout,Phase 1,2023-06-29 00:00:00,"Phase 1 study dosing commenced, noted May 31, 2022. Phase 1 data show edcomparable pharmacokinetic, pharmacodynamic and safety profile between U.S. and Japanese healthy subjects, noted Jue 29, 2023. Phase 1b clinical trial in gout patients in the U.S. and expect to begin pivotal clinical trials in 2024.",6,LABEL_6
+RNXT,Locally advanced pancreatic cancer (LAPC),Phase 3,2023-06-29 00:00:00,"Phase 3 interim data presented at ESMO GI demonstrated an eight-month median PFS benefit, 15 versus 7 months, in delaying the progression of cancer for patients receiving treatment with RenovoGem versus standard-of-care, noted June 29, 2023.",14,LABEL_14
+MNOV,Alcohol Use Disorder (AUD),Phase 2b,2023-06-29 00:00:00,"Phase 2b data reported that treatment was not superior to placebo, noted June 29, 2023.",13,LABEL_13
+ALDX,Retinitis Pigmentosa,Phase 2,2023-06-29 00:00:00,"Phase 2 top-line results presented on a webcast demonstrated statistically significant improvement in retinal function across a number of different physiological and psychophysical assessments, June 29, 2023.",10,LABEL_10
+BTAI,Agitation associated with Alzheimer’s Disease,Phase 3,2023-06-29 00:00:00,"Phase 3 topline data reported that only 60mcg dose met primary endpoint, with a 7.5 point reduction versus 5.4 point reduction in the placebo group, noted June 29, 2023.",14,LABEL_14
+PSTV,Glioma,Phase 1/2,2023-06-29 00:00:00,"Phase 1/2 data presented at the Society of Nuclear Medicine & Molecular Imaging's (SNMMI) Annual Meeting demonstrated efficacy signals in a prognostically unfavorable patient population. The median overall survival (OS) in all 21 patients was 11 months or a 38% increase in OS versus a median OS of approximately 8 months for standard of care in rGBM. Median OS in patients receiving >100 Gy of absorbed radiation dose was 76 weeks versus 22 weeks for those receiving <100 Gy (p=0.0002), noted June 29, 2023.",7,LABEL_7
+CANF,Psoriasis,Phase 3,2023-06-29 00:00:00,"Phase 3 top-line data reported that trial met primary endpoint, noted June 29, 2022. Additionally in their Phase 3 the FDA encouraged the Company to enroll adolescent patients due to the strong safety profile of the drug demonstrated over the development history and prior clinical studies, noted June 29, 2023",14,LABEL_14
+BLCO,Dry Eye Disease Associated With Meibomian Gland Dysfunction,Approved,2023-06-29 00:00:00,"Approved on May 18, 2023.",0,LABEL_0
+CYT,"Hematologic malignancies, solid tumors, triple negative breast cancer",Phase 1,2023-06-30 00:00:00,"Phase 1 development discontinued due to dissolution, noted June 30, 2023.",6,LABEL_6
+SRRK,Spinal muscular atrophy (SMA),Phase 2,2023-06-30 00:00:00,"Phase 2 36-month extension data presented at the Cure SMA Conference showed that continued treatment with apitegromab over the extended treatment period was associated with substantial and sustained improvement in motor function, noted June 30, 2023.",10,LABEL_10
+IPSEY,Primary biliary cholangitis (PBC),Phase 3,2023-06-30 00:00:00,"Phase 3 data reported that trial met primary endpoint, noted June 30, 2023.",14,LABEL_14
+GNFT,Primary biliary cholangitis (PBC),Phase 3,2023-06-30 00:00:00,"Phase 3 data reported that trial met primary endpoint, noted June 30, 2023.",14,LABEL_14
+KRYS,Cystic Fibrosis,Phase 1,2023-07-03 00:00:00,"Phase 1 dosing commenced, noted July 3, 2023",6,LABEL_6
+AMRX,Parkinson's disease,CRL,2023-07-03 00:00:00,"CRL issued by the FDA on July 3, 2023.",2,LABEL_2
+CCCC,Non-Small Cell Lung Cancer (NSCLC),Phase 1a,2023-07-05 00:00:00,"IND Cleared by FDA, July 5, 2023.",8,LABEL_8
+PTGX,Plaque psoriasis,Phase 2b,2023-07-05 00:00:00,"Phase 2b trial met all primary and secondary efficacy endpoints, noted July 5, 2023.",13,LABEL_13
+JNJ,Plaque psoriasis,Phase 2b,2023-07-05 00:00:00,"Phase 2b trial met all primary and secondary efficacy endpoints, noted July 5, 2023.",13,LABEL_13
+MRNA,Respiratory syncytial virus (RSV) vaccine,BLA Filing,2023-07-05 00:00:00,"BLA rolling submission, noted July 5, 2023.",1,LABEL_1
+ALLR,Metastatic breast cancer (mBC),Phase 2,2023-07-05 00:00:00,"Phase 2 intial data showed potential for improved clinical benefit in DRP-selected metastatic breast cancer patients, noted July 5, 2023.",10,LABEL_10
+BIIB,Mild cognitive impairment (MCI) due to Alzheimer's disease (AD),Approved,2023-07-06 00:00:00,"Traditional approval received July 6, 2023.",0,LABEL_0
+BDRX,Diffuse Midline Glioma (DMG),Phase 1,2023-07-06 00:00:00,"Phase 1 trial reported a median overall survival (OS) of 26.1 month, noted July 6, 2023.",6,LABEL_6
+VXRT,Norovirus vaccine,Phase 2,2023-07-06 00:00:00,"Phase 2 topline data reported a similar increase in serum antibody responses with no statistical difference between the medium and high dose arms, and the candidate was well tolerated, noted July 6, 2023.",10,LABEL_10
+CLDX,Eosinophilic esophagitis (EoE),Phase 2,2023-07-06 00:00:00,"Phase 2 dosing initiated, noted July 6, 2023.",10,LABEL_10
+CRIS,Acute Myeloid Leukemia / Myelodysplastic Syndromes (MDS),Phase 1/2,2023-07-06 00:00:00,"FDA removed partial hold, noted July 6, 2023",7,LABEL_7
+KZIA,Brain Metastases,Phase 1,2023-07-06 00:00:00,"FDA awarded Fast Track Designation, noted July 6, 20223.",6,LABEL_6
+GNLX,Malignant pleural effusion (MPE) due to non-small cell lung cancer (NSCLC) or breast cancer.,Phase 1,2023-07-10 00:00:00,"Phase 1 expansion data showed a median overall survival (OS) was 19.5 months. The median OS among patients who had malignant pleural mesothelioma (MPM) was 22 months.. There were no dose-limiting toxicities or dose de-escalations, and the maximally tolerated dose was not reached. Therefore, a recommended dose was not established, noted July 10, 2023.",6,LABEL_6
+TNGX,Solid Tumors,Phase 1/2,2023-07-10 00:00:00,"Phase 1/2 dosing initiated, noted July 10, 2023.",7,LABEL_7
+MDWD,Basal Cell Carcinoma (BCC),Phase 1/2,2023-07-10 00:00:00,"Phase 1/2 data reported that treatment was safe and well-tolerated with eleven out of fifteen patients achieved complete clearance of their BCCs, noted July 10, 2023.",7,LABEL_7
+EXAI,Advanced Solid Tumors,Phase 1/2,2023-07-10 00:00:00,"Phase 1/2 first patient enrolled, noted July 10, 2023.",7,LABEL_7
+VRDN,Active Thyroid Eye Disease (TED),Phase 1/2,2023-07-10 00:00:00,"Phase 1/2 preliminary data demonstrated clinically meaningful and rapid improvement in signs and symptoms of chronic TED at week 6 after receiving two infusions of VRDN-001 10 mg/kg or 3 mg/kg, noted July 10, 2023.",7,LABEL_7
+BDRX,Children with Newly Diagnosed Diffuse Midline Gliomas (DMGs),Phase 1,2023-07-10 00:00:00,"Phase 1 enrollment completed, noted July 10, 2023.",6,LABEL_6
+GOVX,Head and neck squamous cell carcinoma (HNSCC),Phase 1/2,2023-07-10 00:00:00,"Phase 1/2 study data presented at AHNS resulted on impairment of tumor growth (i.e., ""stable disease"" using RECIST 1.1 evaluation criteria) in targeted lesions was seen in 5 of 7 patients; tumor response assessment in one patient remains under study, noted July 10, 2023.",7,LABEL_7
+IBRX,Acute myeloid leukemia (AML),Phase 1,2023-07-10 00:00:00,"Phase 1 results presented at the AHNS indicated the potential for a new treatment approach for the disease in advanced cases that currently have extremely poor prognoses, noted July 10, 2023.",6,LABEL_6
+IOVA,anti-PD-1 therapy for advanced (unresectable or metastatic) Non-small Cell Lung Cancer (NSCLC),Phase 2,2023-07-10 00:00:00,"Phase 2 preliminary data in the trial showed that the median duration of response wasn't reached. Treatrdent-emergent adverse events were consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and interleukin-2, noted July 10, 2023.",10,LABEL_10
+TNXP,Pediatric obesity related binge eating disorder,Phase 2,2023-07-10 00:00:00,"Phase 2 trial initiated, noted July 10, 2022.",10,LABEL_10
+FBIO,Papulopustular Rosacea,Phase 3,2023-07-11 00:00:00,"Phase 3 topline data achieved the co-primary and all secondary endpoints and subjects completed the 16-week treatment with no significant safety issues, noted July 11, 2023.",14,LABEL_14
+ADCT,High-Risk Relapsed/Refractory Follicular Lymphoma,Phase 2,2023-07-11 00:00:00,"Phase 2 trial enrollment voluntarily paused after recent review of aggregate data of the 40 patients enrolled in the trial and consultation with the Data Monitoring Committee (DMC) which signaled potentially excessive respiratory-related events, noted July 11, 2023.",10,LABEL_10
+DERM,Papulopustular Rosacea,Phase 3,2023-07-11 00:00:00,"Phase 3 topline data achieved the co-primary and all secondary endpoints and subjects completed the 16-week treatment with no significant safety issues, noted July 11, 2023.",14,LABEL_14
+SYBX,Phenylketonuria (PKU),Phase 1,2023-07-11 00:00:00,"FDA Granted Fast Track Designation on July 11, 2023.",6,LABEL_6
+CLDX,Chronic spontaneous urticaria (CSU),Phase 2,2023-07-11 00:00:00,"Phase 2 data ahead of schedule, enrollment completed, noted July 11, 2023.",10,LABEL_10
+DERM,Papulopustular rosacea,Phase 3,2023-07-11 00:00:00,Phase 3 topline data achieved the co-primary and all secondary endpoints and subjects completed the 16-week treatment with no significant safety issues. NDA filing due in 2H 2023.,14,LABEL_14
+PULM,Acute migraine,Phase 1,2023-07-11 00:00:00,"IND submitted to FDA to initiate Phase 2 trial, noted July 11, 2023.",6,LABEL_6
+CGTX,Geographic Atrophy Secondary to Dry Age-related Macular Degeneration (AMD),Phase 1,2023-07-11 00:00:00,"Phase 2 trial dosing initiated, noted July 11, 2023.",6,LABEL_6
+ADIL,Alcohol use disorder,Phase 3,2023-07-11 00:00:00,"FDA reviewed the safety data from the ONWARD trial and did not express any concerns with the data, noted July 11, 2023.",14,LABEL_14
+CRBU,B-Cell Non-Hodgkin Lymphoma,Phase 1,2023-07-13 00:00:00,"Phase 1 update reported a 94% overall response rate (ORR), 69% complete response (CR) rate, and 44% CR rate at ≥6 months following a single dose of CB-010, with 24 months as the longer CR maintained to date, noted July 13, 2023.",6,LABEL_6
+FWBI,Exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP),Phase 2,2023-07-13 00:00:00,"Phase 2 topline Initial data from the study indicated the enhanced adrulipase formulation was safe and well tolerated and demonstrated an improvement over prior formulations of adrulipase. However, the preliminary data also indicate that it is likely the primary efficacy endpoint was not achieved, noted July13,. 2023.",10,LABEL_10
+CALT,Squamous Cell Carcinoma of the Head and Neck (SCCHN),Phase 2,2023-07-13 00:00:00,"Phase 2 biomarker data reported that 7 out of the 16 evaluable patients were progression-free with either stable disease or partial response, out of which 6 were in the setanaxib arm and 1 was in the placebo arm, noted July 13, 2023.",10,LABEL_10
+ZLAB,Gastric and gastro-esophageal junction cancer,Phase 3,2023-07-14 00:00:00,"Trial in China initiated, noted July 14, 2023.",14,LABEL_14
+AMGN,Gastric and gastro-esophageal junction cancer,Phase 3,2023-07-14 00:00:00,"Trial in China initiated, noted July 14, 2023.",14,LABEL_14
+GILD,Covid-19,Approved,2023-07-14 00:00:00,"Approved July 14, 2023.",0,LABEL_0
+HALO,Chronic inflammatory demyelinating polyneuropathy (CIDP),Phase 2,2023-07-17 00:00:00,"Phase 2 trial met primary endpoints, noted July 17, 2023.",10,LABEL_10
+ARGX,Chronic inflammatory demyelinating polyneuropathy,Phase 2,2023-07-17 00:00:00,Phase 2 top-line data met primary endpoint; VYVGART Hytrulo demonstrated 61% reduction in risk of relapse versus placebo,10,LABEL_10
+HALO,Chronic inflammatory demyelinating polyneuropathy (CIDP),Phase 2,2023-07-17 00:00:00,"Phase 2 trial met primary endpoints, noted July 17, 2023.",10,LABEL_10
+ARGX,Chronic inflammatory demyelinating polyneuropathy (CIDP),Phase 2,2023-07-17 00:00:00,"Phase 2 trial met primary endpoints, noted July 17, 2023.",10,LABEL_10
+ZLAB,Chronic inflammatory demyelinating polyneuropathy (CIDP),Phase 2,2023-07-17 00:00:00,"Phase 2 trial met primary endpoints, noted July 17, 2023.",10,LABEL_10
+VIRI,Long COVID-19,Phase 2,2023-07-17 00:00:00,"Phase 2 data reported clinically and statistically significant improvements in fatigue, pain, and symptoms of autonomic dysfunction, noted July 17, 2023.",10,LABEL_10
+BPTH,Solid tumors,Phase 1,2023-07-17 00:00:00,"Phase 1/1b first cohort completed, noted July 17, 2023",6,LABEL_6
+VAXX,Parkinson's disease,Phase 1,2023-07-17 00:00:00,"Additional Phase 1 data reported that antibodies derived from UB-312, slowed the seeding of alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) of patients with PD as demonstrated using multiple target engagement assays, noted July 17, 2023.",6,LABEL_6
+PRTA,Alzheimer’s disease,Phase 1,2023-07-17 00:00:00,"Phase 1 SAD data presented at AAIC met key pharmacokinetic (PK) and immunogenicity secondary endpoints, noted July 17, 2023",6,LABEL_6
+LLY,Alzheimer’s disease,Phase 3,2023-07-17 00:00:00,"Phase 3 data presented at AAIC reported a 60% slowing of decline compared to placebo with nearly half of participants at earlier stage of disease on donanemab had no clinical progression at 1 year, noted July 17, 2023.",14,LABEL_14
+AZN,Respiratory syncytial virus,Approved,2023-07-17 00:00:00,"FDA Approved on July 17, 2023.",0,LABEL_0
+KPTI,Myelofibrosis - naïve,Phase 2,2023-07-17 00:00:00,"FDA Granted Fast Track Designation on July 17, 2023.",10,LABEL_10
+CORT,Nonalcoholic steatohepatitis (NASH),Phase 1b,2023-07-17 00:00:00,"Phase 1b data demonstrated that miricorilant effectively reduced liver fat, improved liver health and key metabolic and lipid measures and is well-tolerate, noted July 17, 2023.",9,LABEL_9
+IMMX,Solid tumors,Phase 1/2,2023-07-17 00:00:00,"Phase 1b/2a additional data noted that tumor shrinkage was observed in 3 out of 4 (75%) patients; 1 out of 4 (25%) experienced tumor control as of the July 7, 2023 clinical data cutoff date. All patients had stage IV relapsed/refractory metastatic colorectal cancer and received 8 median lines of therapy prior to IMX-110 + tislelizumab, noted July 17, 2023.",7,LABEL_7
+BLRX,Pancreatic ductal adenocarcinoma (PDAC),Phase 2,2023-07-17 00:00:00,"Phase 2b trial initiated, noted July 17, 2023.",10,LABEL_10
+JANX,Metastatic castration-resistant prostate cancer (mCPRC),Phase 1,2023-07-17 00:00:00,"Phase 1 interim clinical data showed tumor-activated T cell engagement in patients with prostate cancer representing the first-in-human data for the TRACTr platform and providing confidence for continuing clinical development of JANX007 and advancing future programs from the platform, noted July 17, 2023.",6,LABEL_6
+ACIU,Neurodegenerative diseases (NDD),Phase 1,2023-07-18 00:00:00,"Updated biomarker data reported that ACI-15916shows significantly improved specific binding to pathological a-syn aggregates in brain sections from different a-synucleinopathy cases, noted July 18, 2023.",6,LABEL_6
+LGND,Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS),Phase 1b,2023-07-18 00:00:00,"Phase 1b expansion trial data reported that one patient remained on study with sustained complete response for 8 cycles, noted July 18, 2023.",9,LABEL_9
+APVO,Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS),Phase 1b,2023-07-18 00:00:00,"Phase 1b expansion trial data reported that one patient remained on study with sustained complete response for 8 cycles, noted July 18, 2023.",9,LABEL_9
+MRK,Cervical cancer,Phase 3,2023-07-19 00:00:00,"Phase 3 data reported that trial met the PFS primary endpoint, noted July 19, 2023.",14,LABEL_14
+SNPX,Multiple sclerosis (MS),Phase 1,2023-07-19 00:00:00,"IND submitted to FDA, noted July 19, 2023",6,LABEL_6
+PFE,Streptococcus Vaccine,Phase 2,2023-07-19 00:00:00,"Phase 2 results showed that the investigational vaccine, GBS6, was generally well-tolerated and generated robust maternal antibody responses that were efficiently transferred to infants, noted July 19, 2023.",10,LABEL_10
+NBTX,Non-small cell lung cancer (NSCLC),Phase 1/2,2023-07-19 00:00:00,"Phase 1/2 dosing initiated, noted July 19, 2023.",7,LABEL_7
+HRMY,Excessive daytime sleepiness associated with Prader-Willi Syndrome (PWS),Phase 2,2023-07-20 00:00:00,"EoP2 meeting completed, noted July 20, 2023",10,LABEL_10
+VIR,Influenza,Phase 2,2023-07-20 00:00:00,"Phase 2 trial did not meet its primary endpoint, noted July 20, 2023.",10,LABEL_10
+MDNA,Recurrent Glioblastoma (GBM),Phase 2b,2023-07-20 00:00:00,"Phase 2b trial published in the journal Neuro-Oncology, and when compared to a well-matched external control, bizaxofusp more than doubled the median survival in end-stage rGBM patients, noted July 20, 2023. Phase 3 trial planned.",13,LABEL_13
+FIXX,Phenylketonuria (PKU),Phase 1,2023-07-21 00:00:00,"Phase 1 initial data reported that participant 2 has experienced a meaningful plasma Phe reduction of 49% at 17, and participant 1 had a reduction in plasma phenylalanine (Phe) levels to below the ACMG PKU treatment guideline threshold of <360 μmol/L, noted July 27, 2023.",6,LABEL_6
+GILD,Higher risk-Myelodysplastic Syndrome (MDS),Phase 3,2023-07-21 00:00:00,"Phase 3 ENHANCE study been discontinued due to futility based on a planned analysis, noted July 21, 2023.",14,LABEL_14
+VRCA,Molluscum contagiosum,Approved,2023-07-21 00:00:00,"Approved July 21, 2023.",0,LABEL_0
+PHVS,Hereditary angioedema - on demand,Phase 2,2023-07-21 00:00:00,"Phase 2 data reported that trial met primary and all key secondary endpoints, noted July 21, 2023.",10,LABEL_10
+EBS,Anthrax Vaccine,Approved,2023-07-21 00:00:00,"Approved July 21, 2023.",0,LABEL_0
+SNDX,Chronic Graft versus host disease (cGvHD),Phase 2,2023-07-24 00:00:00,"Phase 2 trial results met its primary endpoint across all cohorts with an overall response rate (ORR) of 74% at a dose of 0.3 mg/kg administered every two weeks, noted July 24, 2023.",10,LABEL_10
+INCY,Chronic Graft versus host disease (cGvHD),Phase 2,2023-07-24 00:00:00,"Phase 2 trial results met its primary endpoint across all cohorts with an overall response rate (ORR) of 74% at a dose of 0.3 mg/kg administered every two weeks, noted July 24, 2023.",10,LABEL_10
+KOD,Diabetic macular edema (DME),Phase 3,2023-07-24 00:00:00,"Phase 3 trial did not meet the primary endpoint, noted July 24, 2023.",14,LABEL_14
+TNGX,Solid Tumors,Phase 1,2023-07-24 00:00:00,"IND cleared by FDA, noted April 3, 2023. Phase 1/2 dosing initiated, noted July 24, 2023.",6,LABEL_6
+LCTX,Non-small cell lung cancer (NSCLC),Phase 1,2023-07-24 00:00:00,"Phase 1 data reported that five of eight patients treated (62.5%) had a best response of immune-related stable disease, and three (37.5%) demonstrated immune-related progressive disease, noted July 24, 2023.",6,LABEL_6
+DYAI,COVID-19 booster vaccine,Phase 1,2023-07-24 00:00:00,"Phase 1 safety data reporter no Serious Adverse Events or Adverse Events of Special Interest have been reported to date, noted July 24, 2023",6,LABEL_6
+BMEA,Acute myeloid leukemia (AML) / acute lymphocytic leukemia (ALL) / Diffuse large B-cell lymphoma (DLBCL) / Multiple myeloma (MM),Phase 1,2023-07-24 00:00:00,"Phase 1 clinical update of AML cohort revealed 2 complete responses (CRs) out of 5 relapsed/refractory AML patients carrying menin-dependent mutations treated at Dose Level 4, noted July 24, 2023.",6,LABEL_6
+PXMD,Human African Trypanosomiasis (HAT),Phase 2b,2023-07-24 00:00:00,"Phase 2b trial met its primary endpoint, noted July 24, 2023.",13,LABEL_13
+LRMR,Friedreich’s ataxia (FA),Phase 2,2023-07-25 00:00:00,"FDA Phase 2 clearance for dose exploration trial and OLE trial, Initiation of open-label extension trial with 25 mg daily dosing expected in 1Q 2024, noted July 25, 2023. Phase 2 50mg cohort topline data expected 1H 2024. Phase 2 interim data expected 4Q 2024.",10,LABEL_10
+TARS,Demodex Blepharitis,Approved,2023-07-25 00:00:00,"FDA approved on July 25, 2023.",0,LABEL_0
+LIAN,Demodex Blepharitis,Approved,2023-07-25 00:00:00,"FDA approved on July 25, 2023.",0,LABEL_0
+STOK,Dravet Syndrome,Phase 1/2,2023-07-25 00:00:00,"Phase 1/2 data presented showed that patients treated with 2 or 3 initial doses experienced substantial and sustained reductions in convulsive seizure frequency; Median reductions at 3 months after last dose of 80% and 89% at 6 months after last dose, compared to baseline, noted July 25, 2023.",7,LABEL_7
+GOSS,Pulmonary arterial hypertension (PAH),Phase 2,2023-07-25 00:00:00,"Phase 2 OLE data reported that 9 of 11 patients continued to improve, with a mean improvement of 9 PVR dual responders of 39%, and 3 patients reached a PVR below 200 dyne*s/cm5n, noted July 25, 2023.",10,LABEL_10
+STOK,Dravet Syndrome,Phase 1/2,2023-07-25 00:00:00,"Phase 1/2a new data suggest clinical benefit for patients 2 to 18 years of age treated with multiple doses of STK-001. The observed reductions in convulsive seizure frequency as well as substantial improvements in cognition and behavior support the potential for disease modification in a highly refractory patient population, noted July 25, 2024",7,LABEL_7
+STOK,Dravet syndrome,Phase 1/2,2023-07-25 00:00:00,"Phase 1/2a OLE OLE data of STK-001 (30mg, 45mg) showed a Sustained reductions in convulsive seizure frequency and improvements in cognition and behavior, noted July 25, 2023.",7,LABEL_7
+KPTI,Endometrial cancer,Phase 3,2023-07-25 00:00:00,"Phase 3 updated exploratory subgroup analysis reported a median PFS of 27.4 months compared to 5.2 months for patients with TP53 wild-type endometrial cancer receiving placebo, noted July 25, 2023.",14,LABEL_14
+STOK,Dravet syndrome,Phase 1/2,2023-07-25 00:00:00,"Additional Phase 1/2s safety data showed that it has been generally well-tolerated among 74 patients treated with single and multiple doses of 10mg to 70mg, noted July 25, 2023.",7,LABEL_7
+ATHE,Multiple System Atrophy (MSA),Phase 2,2023-07-26 00:00:00,"Phase 2 trial recommended by DMC on July 26, 2023.",10,LABEL_10
+LPCN,Liver cirrhosis,Phase 2,2023-07-27 00:00:00,"Phase 2 trial met its primary endpoint, noted July 27, 2023.",10,LABEL_10
+LLY,Obesity or overweight with weight-related comorbidities,Phase 3,2023-07-27 00:00:00,"Phase 3 trial met both co-primary endpoints, noted July 27, 2023.",14,LABEL_14
+LLY,Obesity or overweight with weight-related comorbidities,Phase 3,2023-07-27 00:00:00,"Phase 3 trial met primary endpoint, noted July 27, 2023.",14,LABEL_14
+MRK,Pneumococcal conjugate vaccine,Phase 3,2023-07-27 00:00:00,"Phase 3 trial met primary endpoint, noted July 27, 2023.",14,LABEL_14
+LGND,Pneumococcal conjugate vaccine,Phase 3,2023-07-27 00:00:00,"Phase 3 trial met primary endpoint, noted July 27, 2023.",14,LABEL_14
+LGND,Pneumococcal Conjugate Vaccine,Phase 3,2023-07-27 00:00:00,"Phase 3 trial met primary endpoints, noted July 27, 2023.",14,LABEL_14
+EYPT,Wet age-related macular degeneration (AMD),Phase 2,2023-07-27 00:00:00,"Phase 2 trial continued to demonstrate that EYP-1901 is well tolerated with no reported drug-related ocular or systemic SAEs, noted July 27, 2023.",10,LABEL_10
+MRSN,"Ovarian Cancer, Non Small Cell Lung Cancer",Phase 1/2,2023-07-27 00:00:00,"Phase 1/2 trial did not meet its primary endpoint, noted July 27, 2023.",7,LABEL_7
+MRK,Pneumococcal Conjugate Vaccine,Phase 3,2023-07-27 00:00:00,"Phase 3 trial met primary endpoints, noted July 27, 2023.",14,LABEL_14
+URGN,Low grade non-muscle invasive bladder cancer (LG-NMIBC),Phase 3,2023-07-27 00:00:00,"Phase 3 trial met primary endpoint with 79.2% rate of complete response at 3-months following the initial treatment, noted July 27, 2023.",14,LABEL_14
+URGN,Non-Muscle-Invasive Bladder Cancer,Phase 3,2023-07-27 00:00:00,"Phase 3 trial met primary endpoint, noted July 27, 2023.",14,LABEL_14
+DTIL,Relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL),Phase 1/2,2023-07-27 00:00:00,"Phase 1/2 Type B End of Phase 1 meeting with the FDA provided clarity and direction to advance to Phase 2, noted July 27, 2023.",7,LABEL_7
+BHVN,Spinocerebellar Ataxia (SCA),Phase 3,2023-07-27 00:00:00,"The FDA informed Biohaven that it would not review the recently submitted NDA application for troriluzole given that the study's primary endpoint was not met and thus, would not permit a substantive review. The communication from the FDA indicated that the Company may request a Type A meeting within 30 days, noted July 27, 2023.",14,LABEL_14
+PFE,Spinocerebellar Ataxia (SCA),Phase 3,2023-07-27 00:00:00,"The FDA informed Biohaven that it would not review the recently submitted NDA application for troriluzole given that the study's primary endpoint was not met and thus, would not permit a substantive review. The communication from the FDA indicated that the Company may request a Type A meeting within 30 days, noted July 27, 2023.",14,LABEL_14
+MRK,Non-muscle invasive bladder cancer (NMIBC),Phase 1,2023-07-28 00:00:00,"Phase 1 dosing initiated, noted July 28, 2023.",6,LABEL_6
+IOBT,Non-muscle invasive bladder cancer (NMIBC),Phase 1,2023-07-28 00:00:00,"Phase 1 dosing initiated, noted July 28, 2023.",6,LABEL_6
+ABEO,Recessive dystrophic epidermolysis bullosa (RDEB),BLA Filing,2023-07-28 00:00:00,"BLA filing package completed, noted July 28, 2023. FDA pre-BLA meeting in August 2023, and expected BLA submission on 3Q, 2023.",1,LABEL_1
+FDMT,Wet age-related macular degeneration (AMD),Phase 1/2,2023-07-29 00:00:00,"Phase 1/2 additional dose response data demonstrated in favor of highest tested dose of 3E10 vg/eye, including 100% reduction in supplemental anti-VEGF injections (4 of 4 evaluable patients injection-free) and a clinically meaningful reduction in central subfield thickness (CST) at 36 weeks in patient population with high anti-VEGF need, noted July 29, 2023.",7,LABEL_7
+CTXR,CTCL non-Hodgkin lymphoma,CRL,2023-07-29 00:00:00,"CRL received on July 29, 2023.",2,LABEL_2
+ANNX,Geographic atrophy,Phase 2,2023-07-30 00:00:00,"Phase 2 results presented at ASRS demonstrated dose and time-dependent protection of visual function in GA across multiple measures, noted July 30, 2023.",10,LABEL_10
+CLSD,Wet AMD using suprachoroidal delivery,Phase 2,2023-07-30 00:00:00,"Phase 2 additional data reported meaningful reductions in Anti-VEGF injection burden with stable to improved CRT through month 6, noted July 30, 2023.",10,LABEL_10
+RGNX,Wet AMD using suprachoroidal delivery,Phase 2,2023-07-30 00:00:00,"Phase 2 additional data reported meaningful reductions in Anti-VEGF injection burden with stable to improved CRT through month 6, noted July 30, 2023.",10,LABEL_10
+GSK,Endometrial Cancer,Approved,2023-07-31 00:00:00,"FDA approved on July 31, 2023. Ahead of PDUFA on Sept. 23, 2023.",0,LABEL_0
+IONS,ATTR cardiomyopathy,Phase 3,2023-07-31 00:00:00,"Phase 3 trial initiation announced January 10, 2020. Phase 3 enrollment completed, noted July 31, 2023.",14,LABEL_14
+ANAB,Endometrial Cancer,Approved,2023-07-31 00:00:00,"FDA approved on July 31, 2023. Ahead of PDUFA on Sept. 23, 2023.",0,LABEL_0
+BPTH,Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS),Phase 2,2023-08-01 00:00:00,"Phase 2 interim analysis reported that in cohort 1, twelve of the fourteen evaluable patients (86%) achieved complete remission (CR/CRi) and two (14%) achieved partial remission (PR), and in cohort 2 eight of the fourteen evaluable patients (57%) achieved complete remission (CR/CRi), two (14%) achieved partial remission (PR) and three (22%) achieved stable disease, noted August 1, 2023.",10,LABEL_10
+CLSD,Diabetic retinopathy,Phase 2,2023-08-01 00:00:00,"Phase 2 additional data reported that 20% of patients achieved a >2-step improvement vs. 10% in control and 54% of patients achieved any DRSS improvement vs. 20% in control, noted August 1, 2023.",10,LABEL_10
+RGNX,Diabetic retinopathy,Phase 2,2023-08-01 00:00:00,"Phase 2 additional data reported that 20% of patients achieved a >2-step improvement vs. 10% in control and 54% of patients achieved any DRSS improvement vs. 20% in control, noted August 1, 2023.",10,LABEL_10
+QLGN,"Pancreatic cancer, Prostate cancer and other solid tumors",Phase 1a,2023-08-01 00:00:00,"IND cleared by FDA, noted August 1, 2023",8,LABEL_8
+TYRA,Achondroplasia,Phase 2,2023-08-01 00:00:00,"FDA Orphan drug designation (ODD) granted on August 1, 2023.",10,LABEL_10
+ALT,Non-alcoholic fatty liver disease (NAFLD),Phase 2b,2023-08-01 00:00:00,"Phase 2b IMPACT trial enrollment initiated, noted August 1, 2023.",13,LABEL_13
+ICPT,NASH patients with compensated cirrhosis,Phase 3,2023-08-02 00:00:00,"NASH Programs discontinued, noted August 2, 2023.",14,LABEL_14
+ARAV,Platinum Resistant Ovarian Cancer (PROC),Phase 3,2023-08-02 00:00:00,"Phase 3 topline data did not meet primary endpoint of progression-free survival, noted August 2, 2023.",14,LABEL_14
+GTHX,Urothelial carcinoma,Phase 2,2023-08-02 00:00:00,"Phase 2 PFS data reported that PFS was similar between patients receiving trilaciclib prior to gemcitabine/platinum + avelumab and patients receiving gemcitabine/platinum + avelumab alone (median PFS=6.0 months and 6.1 months), noted August 2, 2023.",10,LABEL_10
+MESO,Steroid-refractory acute graft versus host disease (aGVHD) in children,CRL,2023-08-03 00:00:00,"Additional CRL announced August 3, 2023.",2,LABEL_2
+ONCT,Metastatic castration-resistant prostate cancer (mCRPC),Phase 1/2,2023-08-03 00:00:00,"Phase 1/2 study received ""Study May Proceed"" letter by FDA, noted August 3, 2023.",7,LABEL_7
+LUMO,Ebola,Approved,2023-08-03 00:00:00,"Approval in children aged 12 months and older on August 3, 2023.",0,LABEL_0
+MRK,Ebola,Approved,2023-08-03 00:00:00,"Approval in children aged 12 months and older on August 3, 2023.",0,LABEL_0
+ALEC,Frontotemporal Dementia,Phase 2,2023-08-03 00:00:00,"Additional Phase 2 data considered to be uninformative regarding treatment effect, noted August 3, 2023.",10,LABEL_10
+AFMD,"EGFR-expressing tumors, Non-small cell lung cancer, and Squamous cell carcinoma of the head and neck",Phase 1,2023-08-03 00:00:00,"Phase 1 dose-escalation update reported that AFM24 showed meaningful clinical activity in heavily pretreated patients with EGFRmut NSCLC (ORR [13%], DCR [47%]) with significant tumor reductions, including two confirmed PRs and five patients exhibiting stable disease, noted August 3, 2023.",6,LABEL_6
+BIIB,Major depressive disorder (MDD),CRL,2023-08-04 00:00:00,"CRL issued August 4, 2023.",2,LABEL_2
+SAGE,Major depressive disorder (MDD),CRL,2023-08-04 00:00:00,"CRL issued August 4, 2023.",2,LABEL_2
+BIIB,Postpartum Depression,Approved,2023-08-04 00:00:00,"Approved August 4, 2023.",0,LABEL_0
+SAGE,Postpartum Depression,Approved,2023-08-04 00:00:00,"Approved August 4, 2023.",0,LABEL_0
+RCUS,Metastatic castrate-resistant prostate cancer (mCRPC),Phase 1/2,2023-08-07 00:00:00,"Phase 1/2 trial is not expected to demonstrate sufficient clinical benefit in castrate resistant prostate cancer to warrant further investment, noted August 7, 2023.",7,LABEL_7
+PRAX,Epilepsy,Phase 1,2023-08-07 00:00:00,"Phase 1 study demonstrated pharmacodynamic activity across all dose levels for study subjects who received PRAX-628 at first administration as compared with subjects who received a placebo, noted August 7, 2023. Based on these studies and the preclinical results, Praxis intends to advance PRAX-628 into a Phase 2 study in focal epilepsy in the 1H 2024.",6,LABEL_6
+VTGN,Social Anxiety Disorder (SAD),Phase 3,2023-08-07 00:00:00,"Phase 3 topline data met its primary endpoint, noted August 7, 2023.",14,LABEL_14
+PASG,GM1 gangliosidosis (GM1),Phase 1/2,2023-08-07 00:00:00,"Phase 1/2 initial safety data from cohorts 1-4 up to 28 months showed Dose 1 and 2 of PBGM01 were well tolerated and had a favorable safety and immunological profile, noted August 7, 2023.",7,LABEL_7
+SAGE,Major Depressive Disorder (MDD),Phase 3,2023-08-07 00:00:00,"Phase 3 additional data reported that there were no new safety signals identified, noted August 7, 2023.",14,LABEL_14
+OCS,Inflammation and pain following ocular surgery,Phase 3,2023-08-08 00:00:00,"Phase 3 trial met both primary endpoints, noted August 8, 2023.",14,LABEL_14
+DRUG,Dravet Syndrome,Phase 1/2,2023-08-08 00:00:00,"Additional Phase 1/2 cohort 4 data reported an increase in central delta power and robust reduction in central alpha and beta power in active group, as previously reported for Anti-Epileptic Drugs (AEDs) in healthy individuals, noted August 8, 2023.",7,LABEL_7
+NVO,Obesity,Phase 3,2023-08-08 00:00:00,"Phase 3 trial met its primary endpoint, with statistically significant and superior reduction in MACE of 20% for people treated with semaglutide 2.4 mg compared to placebo, noted August 8, 2023.",14,LABEL_14
+PBYI,Small Cell Lung Cancer (SCLC),Phase 1a,2023-08-08 00:00:00,"FDA IND Clearance on August 8, 2023.",8,LABEL_8
+MRTX,MTAP-deleted cancers,Phase 1,2023-08-08 00:00:00,"Phase 1 data reported a safety profile and early signs of clinical activity, noted August 8, 2023.",6,LABEL_6
+VIRX,Epstein-Barr Virus Associated Lymphoma,Phase 1/2,2023-08-08 00:00:00,"Phase 1b/2 data results showed complete responses achieved and ongoing durable responses observed out to approximately 36 months across multiple EBV+ lymphoma subtypes, including some of the most aggressive cancers, noted August 8, 2023.",7,LABEL_7
+TERN,Nonalcoholic steatohepatitis (NASH),Phase 2a,2023-08-08 00:00:00,"Phase 2a topline data reported that the trial met all primary and secondary endpoints, noted August 8, 2023.",12,LABEL_12
+ATAI,Healthy volunteers,Phase 1,2023-08-08 00:00:00,"Phase 1 was generally well-tolerated with no SAE reported. At the 60mg IV dose, rates of sedation and dissociation were consistent with prior studies of PCN-101 at this dose-level, noted August 8, 2023.",6,LABEL_6
+ICVX,Respiratory syncytial virus (RSV) vaccine,Phase 1b,2023-08-08 00:00:00,"Phase 1b 12 month extension trial in older adults, GMTs against RSV through day 365 persisted at ~45-70% of the GMTs at day 28 (for 75 and 250 µg unadjuvanted dosages), noted August 8, 2023.",9,LABEL_9
+PRAX,Essential tremor,Phase 2,2023-08-08 00:00:00,"Phase 2 patients dosed with ulixacaltamide up to 14 weeks showed maintained or improved efficacy results, as measured by mean changes in the modified Activities of Daily Living 11 (mADL111). Patients withdrawing from ulixacaltamide to placebo experienced worsening in mADL11, noted August 8, 2023.",10,LABEL_10
+GRTX,Severe Oral Mucositis (SOM),CRL,2023-08-09 00:00:00,"FDA issued a Complete Response Letter (CRL), noted August 9, 2023.",2,LABEL_2
+PALI,Reduction in adhesions following abdominal and pelvic surgery,Phase 2,2023-08-09 00:00:00,"Phase 2 study did not achieve primary efficacy endpoint of reducing adhesions in LB1148 treated patients compared to placebo treated patients post bowel resection surgery, noted August 9, 2023.",10,LABEL_10
+MRK,Solid tumors,Phase 1/2,2023-08-09 00:00:00,"Phase 1/2 sixth dose escalation cohort data and agent expansion data to showed durable anti-cancer activity observed during monotherapy dose escalation without dose-limiting toxicities. Late-stage pancreatic cancer patient achieved 80% tumor shrinkage with complete regression observed in two of three metastatic lesions in the liver in response to single-agent MDNA11, noted August 9, 2023.",7,LABEL_7
+MDNA,Solid tumors,Phase 1/2,2023-08-09 00:00:00,"Phase 1/2 sixth dose escalation cohort data and agent expansion data to showed durable anti-cancer activity observed during monotherapy dose escalation without dose-limiting toxicities. Late-stage pancreatic cancer patient achieved 80% tumor shrinkage with complete regression observed in two of three metastatic lesions in the liver in response to single-agent MDNA11, noted August 9, 2023.",7,LABEL_7
+ALXO,Myelodysplastic syndromes (MDS),Phase 1b,2023-08-10 00:00:00,"Phase 1b data reported that the evorpacept combination did not substantially improve upon the historical activity of azacitidine alone, noted August 10, 2023.",9,LABEL_9
+JNJ,Multiple myeloma,Approved,2023-08-10 00:00:00,"Approved August 10, 2023.",0,LABEL_0
+REGN,Wet age-related macular degeneration (AMD),Phase 2,2023-08-10 00:00:00,"Phase 2 two-year longer-term data demonstrated that the vast majority of aflibercept 8 mg patients with wAMD could maintain or further extend their dosing intervals. Among those who completed the two-year follow-up, noted August 10, 2023.",10,LABEL_10
+VRCA,Basal cell carcinoma,Phase 2,2023-08-10 00:00:00,"Phase 2 data presented at AAD Innovation Academy show consistency inclinical and histological clearance of treated BCC lesions was observed by Day 49 post-treatment with the 8 mg dose of VP-315, with 4 of 6 subjects (67%) showing complete tumor clearance, noted August 10, 2023.",10,LABEL_10
+XFOR,Severe Congenital Neutropenia (SCN),Phase 2,2023-08-10 00:00:00,"Phase 2 data reported that three participants receiving G-CSF and once-daily oral mavorixafor showing robust increases in ANC, maintenance of ANC levels in the normal range, and the ability to reduce G-CSF dose earlier than anticipated, noted August 10, 2023.",10,LABEL_10
+ANNX,Retinal vein occlusion (RVO),Phase 2,2023-08-11 00:00:00,"Phase 2 data reported a long duration of effect with a single dose of standard of care anti-VEGF treatment in two of five treated patients. These two patients also had some positive effects on visual acuity and the retina already during the four weeks before standard of care treatment was used, noted August 11, 2023.",10,LABEL_10
+JNJ,BRCA-positive mCRPC,Approved,2023-08-11 00:00:00,"Approved August 11, 2023.",0,LABEL_0
+DCTH,Liver-dominant ocular melanoma,Approved,2023-08-14 00:00:00,"FDA Approved on August 14, 2023.",0,LABEL_0
+TCRT,Solid tumors,Phase 1/2,2023-08-14 00:00:00,"Program wind down due to prioritization. Phase 1/2 interim data reported a 83% disease control rate, noted August 14, 2023.",7,LABEL_7
+DSGN,Friedreich ataxia (FA),Phase 1,2023-08-14 00:00:00,"Phase 1 ascending dose data reported that DT-216 was generally well-tolerated and achieved a statistically significant and dose-related increase in frataxin (FXN) mRNA levels in skeletal muscle biopsies, noted August 14, 2023.",6,LABEL_6
+PFE,Multiple Myeloma,Approved,2023-08-14 00:00:00,"FDA Approved on August 14, 2023.",0,LABEL_0
+ADPT,Multiple Myeloma,Approved,2023-08-14 00:00:00,"FDA Approved on August 14, 2023.",0,LABEL_0
+RVNC,Cervical Dystonia,Approved,2023-08-14 00:00:00,"Approved on August 14, 2023.",0,LABEL_0
+CNSP,Glioblastoma (GBM) (adult),Phase 2,2023-08-14 00:00:00,"Phase 2 interim update demonstrated its capability to be an innovative treatment in GBM that is safe and well tolerated, which has the potential to be a novel and effective therapy for this disease, noted August 14, 2023.",10,LABEL_10
+GLTO,Idiopathic pulmonary fibrosis (IPF),Phase 2b,2023-08-15 00:00:00,"Phase 2b trial did not meet its primary endpoint, noted August 15, 2023.",13,LABEL_13
+NVS,Wet macular degeneration,Phase 3,2023-08-15 00:00:00,"Phase 3 trial met its primary endpoint, noted August 15, 2023.",14,LABEL_14
+CMRX,H3 K27M-mutant Glioma,Phase 3,2023-08-16 00:00:00,"Phase 3 data from survival analyses published in Cancer Discovery reported that ONC201 frontline treatment, administered post-radiation therapy, demonstrated a statistically significant increase in mOS from diagnosis versus historical controls, noted August 16, 2023.",14,LABEL_14
+IPSEY,Fibrodysplasia ossificans progressiva (FOP),Approved,2023-08-16 00:00:00,"FDA Approved on August 16, 2023.",0,LABEL_0
+MBIO,B-cell Non-Hodgkin Lymphoma & Chronic Lymphocytic Leukemia (CLL),Phase 1/2,2023-08-16 00:00:00,"Initial Phase 1/2 data reported clinical responses from four of four indolent lymphoma patients, including complete response in follicular lymphoma patient previously treated with CD19 CAR-T cell therapy, noted August 16, 2023.",7,LABEL_7
+QSAM,Bone cancer,Phase 1,2023-08-16 00:00:00,"Initial Phase 1 data reported that treatment was well-tolerated with no serious adverse events, a 56% - 64% decrease in SUV in patient one, and that the first two patients experienced significant pain relief and improved mobility within a week after treatment, noted August 16, 2023.",6,LABEL_6
+FBIO,B-cell Non-Hodgkin Lymphoma & Chronic Lymphocytic Leukemia (CLL),Phase 1/2,2023-08-16 00:00:00,"Initial Phase 1/2 data reported clinical responses from four of four indolent lymphoma patients, including complete response in follicular lymphoma patient previously treated with CD19 CAR-T cell therapy, noted August 16, 2023.",7,LABEL_7
+MRK,Advanced renal cell carcinoma (RCC),Phase 3,2023-08-17 00:00:00,"Phase 3 trial met primary endpoint, noted August 18, 2023.",14,LABEL_14
+PCSA,Gastrointestinal Cancer,Phase 1b,2023-08-17 00:00:00,"Phase 1b interim analysis suggested Processa's novel chemotherapy treatment could improve safety and efficacy in more patients by individualizing the dosing regimen for each patient, noted August 17, 2023.",9,LABEL_9
+IMAB,Growth hormone deficiency,Phase 3,2023-08-17 00:00:00,"Phase 3 trial met its primary endpoint, noted August 17, 2023.",14,LABEL_14
+REGN,"Wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR)",Approved,2023-08-18 00:00:00,"Approved August 18, 2023.",0,LABEL_0
+NBIX,Huntington's disease,Approved,2023-08-18 00:00:00,"Approved August 18, 2023.",0,LABEL_0
+REGN,Chaple,Approved,2023-08-18 00:00:00,"Approved August 18, 2023.",0,LABEL_0
+SGEN,HER2+ Metastatic Breast Cancer (MBC),Phase 3,2023-08-19 00:00:00,"Phase 3 trial met primary endpoint, noted August 19, 2023",14,LABEL_14
+EXEL,Castration-Resistant Prostate Cancer,Phase 3,2023-08-21 00:00:00,"Phase 3 data reported that the trial met one of two primary endpoints, demonstrating a statistically significant improvement in progression-free survival (PFS) at the primary analysis, noted August 21, 2023.",14,LABEL_14
+IPSEY,Castration-Resistant Prostate Cancer,Phase 3,2023-08-21 00:00:00,"Phase 3 data reported that the trial met one of two primary endpoints, demonstrating a statistically significant improvement in progression-free survival (PFS) at the primary analysis, noted August 21, 2023.",14,LABEL_14
+GILD,Acute myeloid leukemia (AML),Phase 3,2023-08-21 00:00:00,"Partial hold by the FDA on enrollment, noted August 21, 2023.",14,LABEL_14
+GILD,Acute Myeloid Leukemia (AML),Phase 1/2,2023-08-21 00:00:00,"Partial hold on enrollment by FDA, noted August 21, 2023.",7,LABEL_7
+HCM,Primary immune thrombocytopenia (ITP),Phase 3,2023-08-21 00:00:00,"Phase 3 trial met is primary endpoint, noted August 21, 2023.",14,LABEL_14
+PFE,Respiratory Syncytial Virus (RSV) in infants,Approved,2023-08-21 00:00:00,"FDA approval on August 21, 2023.",0,LABEL_0
+RHHBY,1L Non-Small Cell Lung Cancer (NSCLC) PD-L1 high,Phase 3,2023-08-23 00:00:00,"Phase 3 data reported that median overall survival estimates of 22.9 months in the tiragolumab plus Tecentriq arm, and 16.7 months in the Tecentriq monotherapy arm, noted August 23, 2023.",14,LABEL_14
+AKBA,Anemia due to chronic kidney disease (CKD),NDA Filing,2023-08-24 00:00:00,"NDA to be resubmitted, noted August 25, 2023. Upon acceptance of the NDA, Akebia expects the FDA to set a PDUFA date of six months from the date of submission.",3,LABEL_3
+TSHA,Rett syndrome,Phase 1/2,2023-08-24 00:00:00,"FDA granted Fast Track Designation (FTD), noted August 24, 2023.",7,LABEL_7
+GILD,"COVID-19 in people with mild, moderate and severe hepatic impairment",Approved,2023-08-24 00:00:00,"Approved August 24, 2023.",0,LABEL_0
+NVO,"Heart failure with preserved ejection fraction (HFpEF) and obesity, Type 2 diabetes",Phase 3,2023-08-25 00:00:00,"Phase 3 data reported a mean change in the KCCQ-CSS of a 16.6-point increase at 52 weeks with semaglutide 2.4 mg vs 8.7 points with placebo, leading to an estimated treatment difference of 7.8 points, noted August 25, 2023.",14,LABEL_14
+NVS,Multiple sclerosis (MS),Approved,2023-08-25 00:00:00,"Approved August 25, 2023.",0,LABEL_0
+MRK,Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC),Phase 3,2023-08-25 00:00:00,"Phase 3 data reported that at the second analysis, the trial did not demonstrate an improvement in OS compared to KEYTRUDA plus placebo, noted August 25, 2023.",14,LABEL_14
+ESPR,Cardiovascular Diseases,Phase 3,2023-08-26 00:00:00,"Phase 3 total event data presented at ESC reported that bempedoic acid shows 20% risk reduction in MACE-4 and 17% risk reduction in MACE-3, noted August 26, 2023.",14,LABEL_14
+BBIO,Amyloid cardiomyopathy (ATTR-CM),Phase 3,2023-08-27 00:00:00,"Phase 3 data presented at ESC reported an 81% survival rate on acoramidis and over 30 months, patients survived more and were hospitalized less than has been seen in prior controlled studies, noted August 27, 2023.",14,LABEL_14
+ARWR,Cardiovascular disease / Elevated Lipoprotein,Phase 2,2023-08-28 00:00:00,"Phase 2 data reported at ESC noted that results from the off-treatment extension period show that patients previously dosed with ≥75 mg of olpasiran sustained a ~40-50% placebo-adjusted percent reduction in Lp(a) nearly a year after the last dose, noted August 28, 2023.",10,LABEL_10
+AMGN,Cardiovascular disease / Elevated Lipoprotein,Phase 2,2023-08-28 00:00:00,"Phase 2 data reported at ESC noted that results from the off-treatment extension period show that patients previously dosed with ≥75 mg of olpasiran sustained a ~40-50% placebo-adjusted percent reduction in Lp(a) nearly a year after the last dose, noted August 28, 2023.",10,LABEL_10
+TBPH,Neurogenic orthostatic hypotension (nOH),Phase 3,2023-08-28 00:00:00,"Additional subgroup data reported benefits of ampreloxetine ranged from 0.5 to 2.2 point improvements relative to placebo across all subgroup categories and were demonstrated on the OHSA and OHQ composite scores, noted August 28, 2023.",14,LABEL_14
+VALN,Chikungunya Vaccine for adolecents,Phase 3,2023-08-28 00:00:00,"Phase 3 trial data reported that VLA1553 was generally safe and well tolerated in adolescents aged 12 to 17 years, regardless of previous CHIKV infection, noted August 28, 2023.",14,LABEL_14
+ANIP,Severe vasomotor symptoms (hot flashes and night sweats) due to menopause,Approved,2023-08-28 00:00:00,"Approved August 28, 2023.",0,LABEL_0
+NVCR,Ovarian cancer,Phase 3,2023-08-28 00:00:00,"Phase 3 trial did not meet its primary endpoint in the final analysis, noted August 28, 2023.",14,LABEL_14
+NVS,"Atherosclerotic cardiovascular disease (ASCVD), increased risk of ASCVD or heterozygous familial hypercholesterolemia (HeFH)",Phase 3,2023-08-28 00:00:00,"Phase 3 data reported that eight in ten patients achieved target LDL-C threshold, noted August 28, 2023.",14,LABEL_14
+OCUP,Diabetic Retinopathy (DR) / Macular Edema (DME),Phase 2,2023-08-28 00:00:00,"Phase 2 data reported that APX3330 achieved statistical significance in preventing clinically meaningful progression of diabetic retinopathy, noted August 28, 2023.",10,LABEL_10
+BIVI,Parkinson's disease,Phase 2a,2023-08-28 00:00:00,"Phase 2a results reported that in comparison of Day 1 and Day 14 of treatment, PK parameters demonstrated that NE3107 administration did not affect the PK profile of levodopa, noted August 28, 2023.",12,LABEL_12
+BMY,"First-line, lower-risk Myelodysplastic syndromes (MDS)",Approved,2023-08-28 00:00:00,"Approved August 28, 2023.",0,LABEL_0
+MRK,"First-line, lower-risk Myelodysplastic syndromes (MDS)",Approved,2023-08-28 00:00:00,"Approved August 28, 2023.",0,LABEL_0
+BFRI,Actinic Keratosis on face & scalp,Phase 1,2023-08-28 00:00:00,"Phase 1 data reported that treatment was generally well tolerated and all TEAEs were transient, noted August 28, 2023.",6,LABEL_6
+LIAN,Obstructive hypertrophic cardiomyopathy (oHCM),Phase 3,2023-08-28 00:00:00,"Phase 3 data presented at ESC reported that treatment demonstrated improvement in Valsalva LVOT peak gradient, LVOT obstruction, clinical symptoms, health status, cardiac biomarkers, and cardiac structure in Chinese oHCM patients, noted August 28, 2023.",14,LABEL_14
+CLNN,Amyotrophic Lateral Sclerosis,Phase 2,2023-08-29 00:00:00,"Phase 2 OLE data reported a significant median survival benefit of 19.3 months using the rank-preserving structural failure time model (RPSFTM) and a significant 52% decreased risk of ALS clinical worsening events, noted August 29, 2023.",10,LABEL_10
+FGEN,Duchenne Muscular Dystrophy,Phase 3,2023-08-29 00:00:00,"Phase 3 topline data reported that the trial did not meet its primary endpoint, noted August 29, 2023.",14,LABEL_14
+NBIX,Tardive dyskinesia (TD),Phase 3,2023-08-29 00:00:00,"Phase 3 data reported that the mean AIMS total score at baseline was 14.6 and decreased over 48 weeks, with a mean change from baseline of -10.2 , noted August 29, 2023.",14,LABEL_14
+RGNX,"Batten Disease, CLN2",Phase 1,2023-08-30 00:00:00,"Phase 1 initial interim data reported that treatment was well tolerated with no serious adverse events. Key efficacy measures demonstrated sustained levels of TPP1 along with increased intervals between enzyme replacement therapy (ERT) infusions and an 86% reduction in seizure frequency through six month, noted August 30, 2023.",6,LABEL_6
+RGNX,Mucopolysaccharidosis Type I (MPS I),Phase 1/2,2023-08-30 00:00:00,"Phase 1/2 initial interim analysis reported that cognitive function was higher than the age equivalent scores in the available natural history, noted August 30, 2023.",7,LABEL_7
+DNLI,Hunter syndrome MPS II,Phase 1/2,2023-08-30 00:00:00,"Additional data from SSIEM reported that data demonstrate rapid and sustained normalization of CSF heparan sulfate to normal healthy levels and improvement in lysosomal function biomarkers, noted August 30, 2023.",7,LABEL_7
+ORTX,Metachromatic leukodystrophy (MLD),Phase 3,2023-08-31 00:00:00,"Announced long-term results from 39 patients that demonstrated that administration of one-time gene therapy resulted in statistically significant improvement in severe motor impairment-free survival with up to 12 years of follow-up (median 6.76 years), noted August 31, 2023.",14,LABEL_14
+ADCT,Diffuse Large B-Cell Lymphoma (DLBCL),Phase 3,2023-08-31 00:00:00,"Phase 3 updated data from safety lead-in portion of study reported that the overall response rate by central review was 16/20 (80%). A total of 10/20 (50%) and 6/20 (30%) patients attained complete and partial response, respectively, noted August 31, 2023.",14,LABEL_14
+RLYB,Paroxysmal nocturnal hemoglobinuria (PNH); Generalized Myasthenia Gravis (gMG),Phase 1,2023-09-03 00:00:00,"Phase 1 multiple ascending trial data reported maximum exposures of greater than 1 µM and 3 µM, respectively, and greater than 99% reductions in free C5 concentrations, noted September 3, 2023.",6,LABEL_6
+IGMS,Hepatocellular carcinoma (HCC),Phase 1/2,2023-09-05 00:00:00,"Phase 1b/2 interim data reported complete response was recorded in 1 patient, partial response in 2 patients, and stable disease in 2 patients, noted September 5, 2023.",7,LABEL_7
+VTRS,Children Living with HIV,Approved,2023-09-05 00:00:00,"Tentative approval announced September 5, 2023.",0,LABEL_0
+TNXP,fibromyalgia-type Long COVID,Phase 2,2023-09-05 00:00:00,"Phase 2 topline data did not achieve the pre-specified primary endpoint of improving Long COVID pain intensity scores at Week 14, noted September 5, 2023.",10,LABEL_10
+KRYS,Alpha-1 antitrypsin deficiency (AATD),Phase 1a,2023-09-05 00:00:00,"FDA granted Orphan Drug Designation, noted September 5, 2023.",8,LABEL_8
+PFE,Focal Epilepsy,Phase 1,2023-09-05 00:00:00,"Examination of EEG in healthy subjects administered single doses confirmed central nervous system (CNS) activity consistent with effects observed with other antiseizure medications, noted September 5, 2023.",6,LABEL_6
+BHVN,Focal Epilepsy,Phase 1,2023-09-05 00:00:00,"Examination of EEG in healthy subjects administered single doses confirmed central nervous system (CNS) activity consistent with effects observed with other antiseizure medications, noted September 5, 2023.",6,LABEL_6
+AUTL,Pediatric Acute lymphoblastic leukemia (ALL),Phase 1,2023-09-05 00:00:00,"Phase 1 data presented at the Blood journal showed that of 10 responding patients, 5 had emergence of MRD (2) or frank relapse (3) with CD19 and CD22 expressing disease associated with loss of CAR T-cell persistence. Importantly, there were no cases of relapse due to antigen-negative escape, with a median follow-up of 8.7 months. Overall survival was 75% at 6 and 12 months. Six and 12-month event free survival (EFS) were 75% and 60% respectively, noted September 5, 2023.",6,LABEL_6
+RXRX,Clostridium Difficile Infection,Phase 1,2023-09-05 00:00:00,"Phase 1 trial achieved its primary objectives of assessing the safety, tolerability and pharmacokinetic profile of REC-3964. REC-3964 has been well tolerated with no serious adverse events (SAEs) reported, noted September 5, 2023.",6,LABEL_6
+BCDA,Heart Failure,Phase 3,2023-09-05 00:00:00,"Phase 3 review determined that the study is unlikely to meet its primary three-tiered FS efficacy endpoint, as seen from the initial 102 randomized patient set assessed at 12-month follow-up, noted September 5, 2023.",14,LABEL_14
+VBIV,Hepatitis B,Phase 2,2023-09-06 00:00:00,"Additional Phase 2 data significantly increased HBsAg seroconversion rate is strongly associated with BRII-179 treatment and correlates with the increased rate of HBsAg loss3, noted September 6, 2023.",10,LABEL_10
+AZN,Neuromyelitis Optica Spectrum Disorder (NMOSD),CRL,2023-09-06 00:00:00,"CRL issued on September 6, 2023.",2,LABEL_2
+RHHBY,Paroxysmal nocturnal hemoglobinuria (PNH),BLA Filing,2023-09-06 00:00:00,"BLA accepted by FDA, noted Septemeber 6, 2023",1,LABEL_1
+VBIV,Hepatitis B,Phase 2,2023-09-06 00:00:00,"Phase 2a/2b top-line data showed increased HBsAg loss rate at the end of treatment and 12 weeks follow up, noted September 6, 2023.",10,LABEL_10
+VIR,Hepatitis B,Phase 2,2023-09-06 00:00:00,"Additional Phase 2 data significantly increased HBsAg seroconversion rate is strongly associated with BRII-179 treatment and correlates with the increased rate of HBsAg loss3, noted September 6, 2023.",10,LABEL_10
+TNGX,Solid Tumors,Phase 1a,2023-09-06 00:00:00,"IND cleared by FDA, noted September 6, 2023. Phase 1/2 clinical trial to commence 1H 2024.",8,LABEL_8
+HOTH,Atopic Dermatitis (AD),Phase 1b,2023-09-06 00:00:00,"Phase 1b final results reported that 78% of patients reported that their overall health had improved since starting BioLexa as compared to 22% stating that there was no change in their health, or their health was worse, noted September 6, 2023.",9,LABEL_9
+TRVN,Diabetic neuropathic pain (DNP),Phase 1,2023-09-06 00:00:00,"Phase 1 data demonstrated a statistically significant analgesic effect in the capsaicin-induced model, noted on September 6, 2023.",6,LABEL_6
+AMRX,Attention Deficit Hyperactivity Disorder (ADHD),Approved,2023-09-06 00:00:00,"ANDA approved September 6, 2023.",0,LABEL_0
+GLYC,Healthy volunteers,Phase 1a,2023-09-06 00:00:00,"Phase 1a first cohort dosing initiated, noted September 6, 2023.",8,LABEL_8
+VXRT,Norovirus vaccine,Phase 2,2023-09-06 00:00:00,"Phase 2 study met 5 of 6 primary endpoints,.Vaccination led to a statistically significant reduction in infection rate, a non-statistically significant reduction in norovirus acute gastroenteritis (AGE), and a substantial reduction in viral shedding, noted September 7, 2023.",10,LABEL_10
+AMRX,Acute symptomatic hypocalcemia in pediatric and adult patients,Approved,2023-09-06 00:00:00,"FDA ANDA Approved based on FDA's Competitive Generic Therapy (CGT) designation with 180-day exclusivity on September 6, 2023.",0,LABEL_0
+APLT,Galactosemia,NDA Filing,2023-09-06 00:00:00,"Company pre-NDA meeting with the FDA completed, noted September 6, 2023. NDA submission expected 4Q 2023.",3,LABEL_3
+PFE,Lyme disease,Phase 2,2023-09-07 00:00:00,"Phase 2 data showed that participants seroconverted after the booster dose, yielding seroconversion1 rates (SCRs) of 95.3% and 94.6% for all outer surface protein A (OspA) serotypes in all age groups, noted September 7, 2023.",10,LABEL_10
+VALN,Lyme disease,Phase 2,2023-09-07 00:00:00,"Phase 2 data showed that participants seroconverted after the booster dose, yielding seroconversion1 rates (SCRs) of 95.3% and 94.6% for all outer surface protein A (OspA) serotypes in all age groups, noted September 7, 2023.",10,LABEL_10
+CBAY,Primary biliary cholangitis (PBC),Phase 3,2023-09-07 00:00:00,"Phase 3 registration trial achieved the primary and all key secondary endpoints, noted on September 7, 2023.",14,LABEL_14
+ABBV,Alzheimer’s disease,Phase 2,2023-09-07 00:00:00,"Phase 2 enrollment to be completed, noted September 7, 2023.",10,LABEL_10
+ALNY,Hypertension,Phase 2,2023-09-07 00:00:00,"Phase 2 study met the primary endpoint, noted September 7, 2023.",10,LABEL_10
+DRRX,Alcoholic hepatitis (AH),Phase 2b,2023-09-07 00:00:00,"Phase 2b last patient dosed, noted September 7, 2023",13,LABEL_13
+INTS,Advanced Soft Tissue Sarcoma,Phase 2,2023-09-07 00:00:00,"Orphan Drug Designation granted by the FDA noted Septemeber 7, 2023.",10,LABEL_10
+ARQT,Atopic dermatitis,Phase 3,2023-09-07 00:00:00,"OLE data reported that 61.5% and 66.2% of participants who rolled over from the roflumilast cream arm in INTEGUMENT-1 or -2 demonstrated a 75% improvement from baseline in Eczema Area and Severity Index (EASI-75) after 28 weeks and 56 weeks, respectively, noted September 7, 2023.",14,LABEL_14
+VBIV,Recurrent glioblastoma multiforme (rGBM),Phase 2b,2023-09-07 00:00:00,"Phase 2b treatment in the primary GBM expected to commenced, noted September 7, 2023.",13,LABEL_13
+FDMT,Wet Age-Related Macular Degeneration (wet AMD),Phase 2,2023-09-07 00:00:00,"Phase 2 enrollment commenced, noted September 7, 2023.",10,LABEL_10
+ALEC,Alzheimer’s disease,Phase 2,2023-09-07 00:00:00,"Phase 2 enrollment to be completed, noted September 7, 2023.",10,LABEL_10
+FULC,Facioscapulohumeral muscular dystrophy (FSHD),Phase 3,2023-09-08 00:00:00,"Phase 3 enrollment completed, noted September 8, 2023",14,LABEL_14
+BCTX,"Early stage, newly diagnosed, high-risk triple negative breast cancer (TNBC)",Phase 2,2023-09-08 00:00:00,"Phase 2 trial enrollment completed with initial results of Median overall survival of 13.5 months in vs. 6.7-9.8 months for similar patients reported in the literature, noted September 8, 2023.",10,LABEL_10
+SNPX,Alzheimer's disease,Phase 2b,2023-09-09 00:00:00,"Phase 2b data presented at IBRO reported that nearly all pre-specified secondary endpoints were achieved with statistical significance in the server cohort, noted September 9, 2023.",13,LABEL_13
+RNA,Myotonic dystrophy type 1 (DM1),Phase 1/2,2023-09-09 00:00:00,"Phase 1/2 topline data analysis presented at the Myotonic Dystrophy Foundation Annual Conference reported directional improvements in myotonia (vHOT) as early as 6 weeks after dosing with a sustained effect at Month 6, noted September 9, 2023.",7,LABEL_7
+AZN,Non-small cell lung cancer (NSCLC),Phase 3,2023-09-09 00:00:00,"Phase 3 data presented at WCLC reported a reduced the risk of disease progression or death by 38% compared to TAGRISSO alone and a combination extended median PFS by 8.8 months, noted September 9, 2023.",14,LABEL_14
+CING,ADHD,Phase 3,2023-09-09 00:00:00,"Phase 3 trial full results reported improvements on the PERMP scores with a trend towards statistical significance for PERMP ratings over the 16-hour period, noted September 9, 2023.",14,LABEL_14
+AZN,Metastatic non-squamous non-small cell lung cancer (NSCLC),Phase 2,2023-09-09 00:00:00,"Phase 2 data presented at WCLC reported that objective response rates of 49% and 56% with 5.4 mg/kg and 6.4 mg/kg doses, respectively, in primary analysis, noted September 9, 2023.",10,LABEL_10
+MRTX,Non-Small Cell Lung Cancer / Colorectal Cancer,Phase 1b,2023-09-10 00:00:00,"Phase 1/1b two-year follow-up data presented at the World Conference on Lung Cancer reported a durable efficacy with a median overall survival (OS) of 14.1 months and a 2-year OS rate of 31% in patients with previously treated KRASG12C-mutated NSCLC, noted September 10, 2023.",9,LABEL_9
+PHGE,P. aeruginosa in patients with Cystic Fibrosis (CF),Phase 1/2,2023-09-10 00:00:00,"Phase 1b/2 Part 1 data presented at ERS reported that treatment was well-tolerated with no adverse events related to study drug, noted September 10, 2023.",7,LABEL_7
+GRCL,Relapsed/refractory multiple myeloma (RRMM),Phase 1,2023-09-10 00:00:00,"Phase 1 updated data at EHA demonstrated 100% minimal residual disease (MRD) negativity and 82.8% MRD negative stringent complete response (sCR) in a predominantly high-risk RRMM population, noted June 10, 2023.",6,LABEL_6
+IFRX,Chronic Autoimmune and Inflammatory Diseases,Phase 1,2023-09-11 00:00:00,"Phase 1 SAD results demonstrated an excellent safety and tolerability profile and a favorable pharmacokinetic (PK) and pharmacodynamic (PD) profile, confirming INF904´s best-in-class potential, noted September 11, 2023.",6,LABEL_6
+AZN,Non-small cell lung cancer (NSCLC) without actionable genomic alterations,Phase 1b,2023-09-11 00:00:00,"Phase 1b data reported an objective response rates of 77% and 50% and disease control rates of 92% and 93%, respectively, noted September 11, 2023.",9,LABEL_9
+BLRX,Stem-cell mobilization for autologous transplantation,Approved,2023-09-11 00:00:00,"FDA Approved on September 11, 2023.",0,LABEL_0
+BMY,Non-Small Cell Lung Cancer (NSCLC),Phase 3,2023-09-11 00:00:00,"Phase 3 data demonstrated consistent, durable benefits of Opdivo plus Yervoy vs. chemotherapy at six years, regardless of PD-L1 expression, noted September 11, 2023.",14,LABEL_14
+VERU,ER+/HER2- breast cancer,Phase 3,2023-09-11 00:00:00,"Phase 3 enrollment discontinued due to prioritization with Phase 3 data overall response rates of 12.5% are observed in the enobosarm group in a heavily pretreated population versus no responses in the standard of care active control arm. Overall response rate was 20% for enobosarm monotherapy versus 0% for standard of care active control in patients who had ≤3 lines of prior endocrine therapy in the metastatic setting, noted September 11, 2023. ARTEST clinical data further validates the evaluation of enobosarm in the Phase 3 ENABLAR-2 study.",14,LABEL_14
+CRNX,Acromegaly,Phase 3,2023-09-11 00:00:00,"Phase 3 topline data reported that trial met its primary endpoint, noted September 11, 2023.",14,LABEL_14
+GILD,Non-Small Cell Lung Cancer (NSCLC),Phase 2,2023-09-11 00:00:00,"Phase 2 trial data reported that in both cohorts, the ORR was 56%, and DCR was 82%. Median duration of response (DoR) was not reached at the time of data cut-off, and DoR rate at six months was 88% in both cohorts, noted September 11, 2023.",10,LABEL_10
+MRKR,Lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell treatment,Phase 1,2023-09-11 00:00:00,"Phase 1 clinical update showed that patients with Non-Hodgkin's Lymphoma who relapsed after anti-CD19 CAR T cell therapy tolerated initial dose level well and achieved complete response after MT-601 treatment, noted September 11, 2023.",6,LABEL_6
+EYPT,Non-proliferative diabetic retinopathy (NPDR),Phase 2,2023-09-11 00:00:00,"Phase 2 interim analysis of masked data showed that EYP-1901 is well tolerated with no reported drug-related ocular or systemic serious adverse events, noted September 11, 2023.",10,LABEL_10
+IDYA,"Solid tumors, ovarian cancer",Phase 1,2023-09-11 00:00:00,"Phase 1 data reported tumor shrinkage observed in multiple HRD solid tumor patients, including an endometrial cancer subject with a first imaging assessment of a partial response and an 87% reduction of the CA-125 tumor marker, noted September 11, 2023.",6,LABEL_6
+ARWR,Healthy volunteers and Asthma,Phase 1/2,2023-09-11 00:00:00,"Phase 1/2 preliminary clinical data achieved mean target gene knockdown of up to 90% with a maximum of 95% after a single inhaled administration, noted Septemeber 11, 2023.",7,LABEL_7
+MRK,Pulmonary arterial hypertension (PAH),Phase 3,2023-09-11 00:00:00,"Phase 3 interim results from OLE study represent longest safety and efficacy analysis of sotatercept to date; safety profile of sotatercept consistent with previous studies and efficacy improvements maintained after one year of therapy, noted September 11, 2023.",14,LABEL_14
+IVVD,COVID-19 Prevention,Phase 3,2023-09-11 00:00:00,"Phase 3 dosing initiated, noted September 11, 2023.",14,LABEL_14
+ITCI,Bipolar Depression and Major depressive disorder (MDD),Phase 3,2023-09-11 00:00:00,"Phase 3 data continues to demonstrate statical significance. Lumateperone 42mg also met the key secondary endpoint by demonstrating a statistically significant and clinically meaningful reduction in the Clinician's Global Impression scale or CGI compared to placebo at Week 6 in these three populations, noted September 11, 2023.",14,LABEL_14
+TAK,Psoriasis,Phase 2b,2023-09-11 00:00:00,"Additional Phase 2b data reported that the safety and tolerability profile of TAK-279 in the Phase 2b trial was consistent with previous TAK-279 clinical trials, noted September 11, 2023.",13,LABEL_13
+ABUS,Healthy volunteers,Phase 1,2023-09-11 00:00:00,"Phase 1 discontinued, noted September 11, 2023.",6,LABEL_6
+ABUS,Coronavirus,Phase 1,2023-09-11 00:00:00,"Phase 1 trial discontinued, noted September 11, 2023.",6,LABEL_6
+SLRN,Hidradenitis Suppurativa (HS),Phase 2/3,2023-09-11 00:00:00,"Phase 2b/3 data to did not meet statistical significance at week 16, noted Septemeber 11, 2023.",11,LABEL_11
+BNTX,COVID-19 Vaccine (Omicron Booster),Approved,2023-09-11 00:00:00,"FDA booster approved on September 11, 2023.",0,LABEL_0
+MRNA,Covid-19 Omicron Booster,Approved,2023-09-11 00:00:00,"FDA approved on September 11, 2023.",0,LABEL_0
+PFE,COVID-19 Vaccine (Omicron Booster),Approved,2023-09-11 00:00:00,"FDA booster approved on September 11, 2023.",0,LABEL_0
+AZN,Eosinophilic granulomatosis with polyangiitis (EGPA),Phase 3,2023-09-11 00:00:00,"Phase 3 met the primary endpoint, noted September 11, 2023.",14,LABEL_14
+AIM,Early-stage triple negative breast cancer,Phase 1,2023-09-11 00:00:00,"Phase 1 complete topline results confirmed treatment was well tolerated, with promising clinical activity of pathologic complete response (pCR) + microinvasive residual disease (ypTmic) at 66%, comparable to pembrolizumab/neoadjuvant chemotherapy (NAC), noted September 11, 2023.",6,LABEL_6
+VIGL,Adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP),Phase 1,2023-09-11 00:00:00,"Phase 2 data analysis demonstrated that VGL101 continued to have a favorable safety and tolerability profile and proof-of-target engagement in SAD/MAD cohorts up to 60 mg/kg with six-month interim data expected 4Q 2023, noted Septemeber 11, 2023.",6,LABEL_6
+GOVX,Covid-19,Phase 2,2023-09-11 00:00:00,"Phase 2 target enrollment met, noted September 11, 2023.",10,LABEL_10
+ABUS,"Hepatitis B, healthy volunteers",Phase 1,2023-09-11 00:00:00,"Phase 1 dosing commenced, noted September 11, 2023. Phase 1 preliminary data 1H 2024.",6,LABEL_6
+NBIX,Congenital Adrenal Hyperplasia (CAH) - adults,Phase 3,2023-09-12 00:00:00,"Phase 3 study met its primary endpoint at Week 24, Noted September 12, 2023",14,LABEL_14
+AZN,Non-Small Cell Lung Cancer,Phase 3,2023-09-12 00:00:00,"Phase 3 data presented at WCLC reported statistically significant and clinically meaningful improvement in event-free survival and pathologic complete response with this IMFINZI-based regimen versus neoadjuvant chemotherapy alone followed by surgery, noted September 12, 2023.",14,LABEL_14
+LYRA,Chronic rhinosinusitis,Phase 2,2023-09-12 00:00:00,"Phase 2 top-line results met its primary endpoint with no serious adverse events observed, September 12, 2023.",10,LABEL_10
+NXTC,PD-1 axis inhibitor refractory non-small cell lung cancer (NSCLC),Phase 2,2023-09-12 00:00:00,"Phase 2 data reported that 28% of patients (5/18) had durable clinical benefit with three of these being confirmed responses, noted September 12, 2023.",10,LABEL_10
+ANIP,Menopause symptoms,Approved,2023-09-12 00:00:00,"Approved September 12, 2023.",0,LABEL_0
+LSTA,Solid Tumors,Phase 2a,2023-09-12 00:00:00,"Phase 2a dosing initiated on head and neck squamous cell carcinoma cohort, noted Septemeber 12, 2023.",12,LABEL_12
+VTGN,Premenstrual dysphoric disorder (PMDD),Phase 2a,2023-09-12 00:00:00,"Phase 2a exploratory analysis demonstrated statistically and clinically significant improvement versus placebo, noted Septemeber 12, 2023.",12,LABEL_12
+EIGR,Hepatitis Delta Virus (HDV) infection,Phase 3,2023-09-12 00:00:00,"Phase 3 LIMT-2 trial discontinued due to DSMB recommendation, noted September 12, 2023.",14,LABEL_14
+IOVA,Solid Tumors,Phase 2,2023-09-12 00:00:00,"Phase 2 data presented at WCLC reported that the ORR was 42.1%, noted September 12, 2023.",10,LABEL_10
+NVCT,Non-small cell lung cancer (NSCLC),Phase 1a,2023-09-12 00:00:00,"Phase 1a dose escalation initiated, noted September 12, 2023.",8,LABEL_8
+MRNA,Seasonal influenza,Phase 3,2023-09-13 00:00:00,"Phase 3 trial met all co-primary endpoints, noted September 13, 2023.",14,LABEL_14
+MDGL,Non-alcoholic steatohepatitis (NASH) with liver fibrosis,PDUFA priority review,2023-09-13 00:00:00,https://www.biopharmcatalyst.com/company/MDGL/news/158576,5,LABEL_5
+OCGN,Retinitis Pigmentosa,Phase 1/2,2023-09-13 00:00:00,"Phase 1/2 clinical study update suggested continued positive trends in Best-Corrected Visual Acuity (BCVA) and Multi-Luminance Mobility Testing (MLMT), as well as positive trends in Low-Luminance Visual Acuity (LLVA) among treated eyes 83% (10/12) of subjects demonstrated stabilization or improvement in treated eye either on BCVA or LLVA or MLMT scores from baseline, noted September 13, 2023.",7,LABEL_7
+HOTH,"Aggressive systemic mastocytosis (ASM), mast cell leukemia (MCL), and systemic mastocytosis with associated hematological neoplasm (SM-AHN).",Phase 1a,2023-09-13 00:00:00,"Preclinical Results of Novel HT-KIT Therapeutic Performed at NC State University demonstrated that gastrointestinal Stromal Tumors Cells Rapidly Died Between 48 and 72 Hours After Exposure to HT-KIT. HT-KIT Shows Positive Results in AML, noted September 13, 2023.",8,LABEL_8
+AMGN,Alopecia areata,Phase 2,2023-09-13 00:00:00,"Phase 2 initiated in collaboration with Q32 Bio on September 13, 2023.",10,LABEL_10
+ANTX,Treatment-Refractory MAC Lung Disease,Phase 2/3,2023-09-13 00:00:00,"Phase 2/3 enrollment completed, noted September 13, 2023.",11,LABEL_11
+VINC,Hematologic malignancies,Phase 1,2023-09-14 00:00:00,"IND cleared August 22, 2023. Phase 1 study dosing commenced, noted on September 14, 2023.",6,LABEL_6
+BMY,Spinal Muscular Atrophy (SMA),Phase 3,2023-09-14 00:00:00,"Phase 3 trial to continue dosing, noted November 9, 2022. Phase 3 dosing completed, noted September 14, 2023.",14,LABEL_14
+PFE,Spinal Muscular Atrophy (SMA),Phase 3,2023-09-14 00:00:00,"Phase 3 trial to continue dosing, noted November 9, 2022. Phase 3 dosing completed, noted September 14, 2023.",14,LABEL_14
+SCLX,Acute lower back pain (LBP),Phase 2,2023-09-14 00:00:00,"Phase 2 data reported that none of the subjects in the active group and 3 (8.1%) subjects in placebo group had AEs of special interest, with a meaningful reduction of pain over the first week, noted September 14, 2023.",10,LABEL_10
+AVXL,Mild to moderate Alzheimer’s disease,Phase 2/3,2023-09-14 00:00:00,"Phase 2b/3 full data reported that the least-squares mean (LSM) change from baseline to 48 weeks between the blarcamesine and placebo groups were −1.783; for ADAS-Cog13, and −0.456 for CDR-SB in patients with early Alzheimer's disease, noted September 14, 2023.",11,LABEL_11
+SRNE,Acute lower back pain (LBP),Phase 2,2023-09-14 00:00:00,"Phase 2 data reported that none of the subjects in the active group and 3 (8.1%) subjects in placebo group had AEs of special interest, with a meaningful reduction of pain over the first week, noted September 14, 2023.",10,LABEL_10
+BHVN,Spinal Muscular Atrophy (SMA),Phase 3,2023-09-14 00:00:00,"Phase 3 trial to continue dosing, noted November 9, 2022. Phase 3 dosing completed, noted September 14, 2023.",14,LABEL_14
+GSK,Myelofibrosis,Approved,2023-09-15 00:00:00,"Approved September 15, 2023.",0,LABEL_0
+ELOX,Alport syndrome,Phase 2,2023-09-18 00:00:00,"Phase 2 additional independent confirmation reported that all three patients treated with ELX-02 showed a visual improvement in podocyte foot process effacement post-treatment in kidney biopsies demonstrating the disease modifying effect of ELX-02, noted September 18, 2023.",10,LABEL_10
+ACRS,Healthy volunteers,Phase 1,2023-09-18 00:00:00,"Phase 1 data reported that treatment was was generally well tolerated at all doses, noted September 18, 2023.",6,LABEL_6
+RDHL,H. pylori,Approved,2023-09-18 00:00:00,https://www.biopharmcatalyst.com/company/RDHL/news/159168,0,LABEL_0
+GILD,Large B-cell lymphoma (LBCL) after one prior line of therapy who were deemed ineligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT),Phase 2,2023-09-18 00:00:00,"Phase 2 trial met its primary endpoint, noted September 18, 2023.",10,LABEL_10
+KYMR,Cutaneous T-cell lymphoma (CTCL),Phase 1,2023-09-18 00:00:00,"FDA granted Fast Track Designation in ongoing Phase 1 trial, noted September 18, 2023.",6,LABEL_6
+SXTP,COVID-19 patients with mild-moderate symptoms and low risk of disease progression,Phase 1a,2023-09-18 00:00:00,"IND withdrawn, noted September 18, 2023",8,LABEL_8
+TCON,Sarcomas,Phase 3,2023-09-18 00:00:00,"Phase 2 pivotal trial satisfied more than the futility threshold of 3 responses out of 46 based on the results of the second and final mandated independent data monitoring committee (IDMC) efficacy review, and the trial will continue as planned, noted September 18, 2023.",14,LABEL_14
+KNTE,Solid Tumors,Phase 1,2023-09-18 00:00:00,https://www.biopharmcatalyst.com/company/KNTE/news/159347,6,LABEL_6
+AIMD,Oral warts in HIV-seropositive patients,Phase 3,2023-09-18 00:00:00,"Ainos plans to pursue a pre-IND meeting with the FDA in advance of planned Phase 3 clinical studies, noted September 18, 2023.",14,LABEL_14
+ABBV,Platysma prominence associated with platysma muscle activity (M21-310),Phase 3,2023-09-18 00:00:00,"Phase 3 trial met all primary and secondary endpoints, noted September 18, 2023.",14,LABEL_14
+SAVA,Alzheimer's disease,Phase 3,2023-09-18 00:00:00,"Phase 3 Data and Safety Monitoring Board (DSMB) recommended that both of Cassava Sciences' Phase 3 studies of simufilam continue as planned, without modification, noted September 18, 2023.",14,LABEL_14
+IGXT,Pain,PDUFA priority review,2023-09-19 00:00:00,"In response to the CRL, Xiromed submitted to the FDA an Amendment to the ANDA, requesting priority review, noted September 19, 2023. In an Amendment Acknowledgement received from the FDA by the company, the FDA granted priority review with a Generic Drug User Fee Act (GDUFA) date for review of the Amendment of March 8, 2024, unless the Agency determines that an inspection is required. Alternatively, if the FDA determines that an inspection is required, the GDUFA goal date is July 8, 2024.",5,LABEL_5
+ARQT,Atopic Dermatitis - ages of 2-5 years old,Phase 3,2023-09-19 00:00:00,"Phase 3 top-line data reported that the trial met all its primary and secondary endpoints, noted September 19, 2023.",14,LABEL_14
+RVMD,"Pancreatic cancer, non-small cell lung cancer (NSCLC), and colorectal cancer.",Phase 1,2023-09-19 00:00:00,"Phase 1 dosing initiated, noted Septemeber 19, 2023.",6,LABEL_6
+ALPMY,Geographic atrophy (GA) secondary to age-related macular degeneration (AMD),Phase 3,2023-09-19 00:00:00,"Phase 3 24 month data confirmed that trial met primary endpoint, noted September 19, 2023.",14,LABEL_14
+DYN,Myotonic Dystrophy Type 1 (DM1),Phase 1/2,2023-09-20 00:00:00,"Phase 1/2 initiated Septmember 6, 2022. Phase 1/2 Orphan Drug Designation was granted on September 20, 2023.",7,LABEL_7
+RLMD,Major Depressive Disorder (MDD),Phase 3,2023-09-20 00:00:00,"Phase 3 results showed that patients newly treated with REL-1017 for up to one year experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and associated functional impairment, noted Septemeber 20, 2023.",14,LABEL_14
+VIR,HIV T cell vaccine,Phase 1,2023-09-20 00:00:00,"Phase 1 dosing initiated, noted September 20, 2023.",6,LABEL_6
+RGLS,Autosomal Dominant Polycystic Kidney Disease (ADPKD),Phase 1,2023-09-20 00:00:00,"Phase 1b data showed that it was well tolerated by all 9 subjects receiving active drug with no safety findings. Increases in both PC1 and PC2 biomarkers were observed. Statistically significant increases in mean PC1 levels were observed at Day 85 and Day 86 (n=9) compared to baseline (36%-41%). Numeric increases in PC2 were observed during the treatment period, although not statistically significant, noted September 20, 2023.",6,LABEL_6
+SPRY,Allergic reactions (type I) including anaphylaxis,CRL,2023-09-20 00:00:00,"CRL announced September 20, 2023.",2,LABEL_2
+SEEL,Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder (ASIB in MDD),Phase 2,2023-09-20 00:00:00,"Phase 2 Part 2 cohort data readout demonstrated early and persistent clinically meaningful reductions in symptoms of depression and acute suicidality, noted September 20, 2023.",10,LABEL_10
+MESO,"Pediatric participants with acute graft versus host disease (aGVHD), following allogeneic hematopoietic stem cell transplant (HSCT)",Phase 3,2023-09-21 00:00:00,"Type A meeting noted the lack of a suitable potency assay for the RYONCIL product used during the Phase 3 trial, new potency assay data to be generated, noted September 21, 2023.",14,LABEL_14
+NAMS,Alzheimer's Disease,Phase 2a,2023-09-21 00:00:00,"Phase 2a data observed reductions of 11% and 12% in 24- and 27-hydroxycholesterol in cerebrospinal fluid (CSF), respectively, indicating potential improvement of cholesterol metabolism in the brain. Observed 8% increase in Aβ42/40 ratio, a key biomarker of AD risk, suggesting improvement in disease pathology, noted September 21, 2023.",12,LABEL_12
+JSPR,Fanconi Anemia (FA),Phase 1b,2023-09-21 00:00:00,"Phase 1b updated results showed that all three patients treated achieved full donor engraftment and full blood count recovery. Briquilimab was well tolerated without any complications, noted September 21, 2023.",9,LABEL_9
+ETNB,Nonalcoholic Steatohepatitis (NASH),Phase 2b,2023-09-21 00:00:00,"Phase 2b trial received Breakthrough Therapy Designation (BTD) granted by the FDA, noted September 21, 2023.",13,LABEL_13
+TRDA,Duchenne Muscular Dystrophy (DMD),Phase 1,2023-09-21 00:00:00,"Phase 1 trial initiated, noted September 21, 2023.",6,LABEL_6
+CBAY,Primary biliary cholangitis (PBC),Phase 3,2023-09-21 00:00:00,"Phase 3/4 study initiated, noted September 21, 2023.",14,LABEL_14
+LLY,Chronic kidney disease (CKD),Approved,2023-09-22 00:00:00,"FDA Approval on September 22, 2023.",0,LABEL_0
+MRK,Metastatic non-small cell lung cancer (NSCLC),Phase 3,2023-09-22 00:00:00,"Phase 3 data reported that there was not an improvement in OS for patients who received KEYTRUDA plus LENVIMA compared to docetaxel, noted September 22, 2023.",14,LABEL_14
+MRK,Nonsquamous non-small cell lung cancer (NSCLC),Phase 3,2023-09-22 00:00:00,"Phase 3 trial did not meet its dual primary endpoints of overall survival (OS) and progression free survival (PFS), noted September 22, 2023.",14,LABEL_14
+KTRA,Newly diagnosed MGMT-unmethylated Glioblastoma Multiform (GBM),Phase 2,2023-09-23 00:00:00,"Additional Phase 2 case study data to be presented at EANO reported that a patient was tumor-free and has survived more than four years as of the last follow-up in March 2023, and another patient had discontinued treatment and a new lesion was found, noted September 23, 2023.",10,LABEL_10
+ASND,Growth Hormone Deficiency - adults,Phase 3,2023-09-23 00:00:00,"Phase 3 resultspresented at ESPE 2023 showed that the majority of children and adolescents treated once weekly with TransCon hGH (lonapegsomatropin) met or exceeded average parental height SDS at time of treatment completion or last visit, noted September 23, 2023.",14,LABEL_14
+MORF,Ulcerative colitis,Phase 2a,2023-09-23 00:00:00,"Phase 2a trial achieved the primary endpoint and demonstrated clinically meaningful improvements across secondary and exploratory measures, noted September 22, 2023.",12,LABEL_12
+APLIF,Parasitic and anaerobic bacterial infections,Approved,2023-09-25 00:00:00,"Approved September 25, 2023.",0,LABEL_0
+CLNN,Amyotrophic Lateral Sclerosis (ALS),Phase 2/3,2023-09-25 00:00:00,"Phase 2/3 post hoc results showed significantly improved survival with a 49% decreased risk of death for the covariate risk-adjusted analyses compared to the largest U.S. clinical database of previous amyotrophic lateral sclerosis (ALS) trials (PRO-ACT), noted September 25, 2023.",11,LABEL_11
+NVS,Gastroenteropancreatic neuroendocrine tumors (GEP-NETs),Phase 3,2023-09-25 00:00:00,"Phase 3 trial met primary endpoint of improvement in progression-free survival (PFS) and key secondary endpoint of objective response rate (ORR), noted September 25, 2023.",14,LABEL_14
+CHRS,Cancer,CRL,2023-09-25 00:00:00,"CRL issued September 25, 2023.",2,LABEL_2
+LQDA,Interstitial lung disease (PH-ILD),PDUFA,2023-09-25 00:00:00,"FDA confirmed resubmission as Class II, PDUFA date assigned on January 24, 2024. Additionally, the FDA may not grant final approval of the PH-ILD indication until after the new clinical investigation exclusivity granted to Tyvaso expires on March 31, 2024, noted September 25, 2023.",4,LABEL_4
+BIOR,Ulcerative Colitis (UC),Phase 1a,2023-09-25 00:00:00,"IND submitted to FDA, noted September 25, 2023.",8,LABEL_8
+IMVT,Autoimmune diseases,Phase 1,2023-09-26 00:00:00,"Phase 1 data reported no dose-related changes in serum albumin or LDL-C, and the mean total IgG reduction from baseline in this MAD cohort was 63%, noted September 26, 2023.",6,LABEL_6
+TLSA,Secondary Progressive Multiple Sclerosis (SPMS),Phase 2a,2023-09-26 00:00:00,"Phase 2a trial in na-SPMS initiated, noted September 26, 2023.",12,LABEL_12
+SLNO,Prader-Willi syndrome (PWS),Phase 3,2023-09-26 00:00:00,"Phase 3 trial met its primary endpoint, noted September 26, 2023.",14,LABEL_14
+INZY,ENPP1 deficiency,Phase 2,2023-09-26 00:00:00,"Phase 2 interim data from cohort 1-3 reported an improvement in the Global Impression of Change (GIC) observed in all three dose cohorts in ABCC6 Deficiency (PXE) trial, noted September 26, 2023.",10,LABEL_10
+PLRX,Primary sclerosing cholangitis (PSC),Phase 2a,2023-09-26 00:00:00,"Phase 2a met its primary and secondary endpoints at the 12-week treatment period, noted September 26. 2023.",12,LABEL_12
+CADL,Non-small cell lung cancer (NSCLC),Phase 2,2023-09-26 00:00:00,"Phase 2 initial data suggests 12-month survival is consistent with an increased tail on the maturing survival curve, noted September 26, 2023.",10,LABEL_10
+IONS,Familial Chylomicronemia Syndrome (FCS),Phase 3,2023-09-26 00:00:00,"Phase 3 trial met its primary efficacy endpoint, noted September 26, 2023.",14,LABEL_14
+VERU,"COVID-19 / Severe Acute Respiratory Syndrome, SARS-CoV-2, Influenza A and B, Respiratory Syncytial Virus (RSV) and other viruses",Phase 3,2023-09-26 00:00:00,"Phase 3 new study authorized by FDA, with an FDA meeting in September 2023 resulted in agreement with FDA on New Phase 3 Clinical Trial for Sabizabulin for Broader Indication, noted September 26, 2023.",14,LABEL_14
+YS,Rabies,Phase 3,2023-09-26 00:00:00,"Phase 3 trial initiated, noted September 26, 2023.",14,LABEL_14
+LUMO,Pediatric Growth Hormone Deficiency (PGHD),Phase 2,2023-09-26 00:00:00,"Phase 2 interim data analysis reported that LUM-201 restored GH secretion to similar levels seen in normally growing children, noted September 26, 2023.",10,LABEL_10
+CRDF,Pancreatic ductal adenocarcinoma (PDAC),Phase 2,2023-09-26 00:00:00,"Phase 2 additional data reported an objective response rate (ORR) of 19% and median progression-free survival (mPFS) of 5.0 months, noted September 26, 2023.",10,LABEL_10
+CRDF,Small cell lung cancer (SCLC),Phase 2,2023-09-26 00:00:00,"Phase 2 safety data from the first six patients by the institutional review board confirmed the trial can continue to enroll as planned, noted September 26, 2023.",10,LABEL_10
+ADVM,Wet age-related macular degeneration (AMD),Phase 2,2023-09-26 00:00:00,"Phase 2 14-week data reported that has been generally well-tolerated, with 90% of subjects were still receiving corticosteroid prophylactic taper, noted September 26, 2023.",10,LABEL_10
+ENSC,Severe Pain Relief,Phase 3,2023-09-26 00:00:00,"Phase 3 data presented at the PAINWeek on September 7, 2023. Phase 3 completion of site initiation visit, noted September 26, 2023.",14,LABEL_14
+UBX,Wet age-related macular degeneration (AMD),Phase 2,2023-09-27 00:00:00,"Phase 2 patients on combination treatment with UBX1325 and aflibercept from weeks 24-48 maintained vision gains achieved at week 24 on aflibercept alone, with greater vision improvement in patients with more severe disease. 40% of UBX1325-treated patients did not require anti-VEGF treatment through 48 weeks and 64% achieved an anti-VEGF treatment-free interval of over 24 weeks, noted Septemeber 27, 2023.",10,LABEL_10
+CYBN,Major Depressive Disorder (MDD),Phase 1b,2023-09-27 00:00:00,"Phase 1b data reported that 100% of patients in the SSRI cohort responded to SPL026 (DMT) with 92% of patients in remission from depression, noted September 27, 2023.",9,LABEL_9
+VBIV,Covid-19,Phase 1,2023-09-27 00:00:00,"Phase 1 interim data reported a 25% reduction in GMT against Wuhan after 5 months vs. peak responses, noted September 27, 2023.",6,LABEL_6
+VTRS,Mydriasis (RM),Approved,2023-09-27 00:00:00,"FDA Approval on September 27, 2023.",0,LABEL_0
+GRCL,Diffuse large B-cell lymphoma (DLBCL),Phase 1,2023-09-27 00:00:00,"Additional Phase 1 data presented at IMS reported an 100% overall response rate (ORR) and a 100% MRD- sCR rate among 19 transplant-eligible, high-risk NDMM patients, noted September 27, 2023.",6,LABEL_6
+CALT,Alport Syndrome,Phase 2,2023-09-27 00:00:00,"Phase 2 to be intiated in 4Q 2023. FDA granted Orphan Drug Designation, noted September 27, 2023.",10,LABEL_10
+TAK,Ulcerative Colitis,Approved,2023-09-27 00:00:00,"FDA Approved on September 27, 2023.",0,LABEL_0
+BCLI,Amytrophic lateral sclerosis (ALS),PDUFA,2023-09-27 00:00:00,"Advisory Committee meeting voted 17-1 that NurOwn did not demonstrate substantial evidence of effectiveness for the treatment of mild to moderate ALS, noted September 27, 2023.",4,LABEL_4
+OCUP,Mydriasis (RM),Approved,2023-09-27 00:00:00,"FDA Approval on September 27, 2023.",0,LABEL_0
+BLRX,First-line pancreatic ductal adenocarcinoma (PDAC),Phase 2,2023-09-28 00:00:00,"Phase 2 trial data presented at the AACR Special pancreatic cancer conference reported that 6 patients (55%) experienced a partial response (PR) of which 4 (36%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion, noted September 28, 2023.",10,LABEL_10
+BNOX,Post-Traumatic Stress Disorder (PTSD),Phase 2b,2023-09-28 00:00:00,"Phase 2b topline data met its primary endpoint showing BNC210 treatment led to a statistically significant reduction in total PTSD symptom severity at 12 weeks. Statistically significant secondary endpoints showed improvements in depressive symptoms and sleep, noted September 28, 2023.",13,LABEL_13
+MRK,Pulmonary arterial hypertension (PAH),PDUFA,2023-09-28 00:00:00,"PDUFA date on March 26, 2024.",4,LABEL_4
+IMGN,Cancer - ovarian cancer and relapsed endometrial cancer,Phase 3,2023-09-28 00:00:00,"Additional Phase 3 data reported at ESGO noted that in patients with prior PARPi, ORR in the ELAHERE arm was 45%, including 7 CRs, compared to 17%, with no CRs, in the IC chemotherapy arm, noted September 28, 2023.",14,LABEL_14
+VSTM,KRAS mutant advanced solid tumors,Phase 1/2,2023-09-28 00:00:00,"Phase 1/2 data reported an overall response rate (ORR) of 42% (11 of 26) in evaluable patients with low grade serous ovarian cancer (LGSOC), noted September 28, 2023.",7,LABEL_7
+IMNN,Ovarian cancer,Phase 1/2,2023-09-28 00:00:00,"Phase 1/2 interim data reported efficacy trends in PFS, demonstrating a delay in disease progression in the treatment arm of approximately 33% compared with the control arm, with the hazard ratio nearing the required value. Preliminary OS data follows a similar trend, showing an approximate 9-month improvement in the treatment arm over the control arm, noted September 28, 2023.",7,LABEL_7
+FOLD,Pompe Disease,Approved,2023-09-28 00:00:00,"FDA Approved on September 28, 2023.",0,LABEL_0
+NBTX,Pancreatic cancer,Phase 1,2023-09-28 00:00:00,"Phase 1 data reported a 92.3% local disease control rate (12/13) and a median Overall Survival of 21 months, noted September 28, 2023.",6,LABEL_6
+BXRX,Hemophilia A,Phase 1/2,2023-09-28 00:00:00,"FDA granted Orphan Drug Designation, noted September 28, 2023.",7,LABEL_7
+BIIB,Rheumatoid arthritis (RA),Approved,2023-09-29 00:00:00,"FDA Biosimilar of ACTEMRA approved on September 29, 2023.",0,LABEL_0
+GPCR,Type 2 Diabetes,Phase 1b,2023-09-29 00:00:00,"Phase 1b results reported that GSBR-1290 demonstrated significant weight loss supporting once-daily (QD) dosing, noted September 29, 2023.",9,LABEL_9
+ABBV,Relapsed or refractory multiple myeloma,Phase 3,2023-09-29 00:00:00,"Phase 3 data reported that it showed improvement in median PFS of 9.9 months compared to 5.8 months with the combination of study comparator pomalidomide and dexamethasone; however, the results did not reach statistical significance, noted September 29, 2023.",14,LABEL_14
+RHHBY,Relapsed or refractory multiple myeloma,Phase 3,2023-09-29 00:00:00,"Phase 3 data reported that it showed improvement in median PFS of 9.9 months compared to 5.8 months with the combination of study comparator pomalidomide and dexamethasone; however, the results did not reach statistical significance, noted September 29, 2023.",14,LABEL_14
+MBRX,Acute Myeloid Leukia (AML),Phase 1b,2023-10-02 00:00:00,"Phase 1b portion of Phase 1B/2 study demonstrated preliminary CR/CRi rate of 33%, noted Octobeer 2, 2023.",9,LABEL_9
+LGND,ER+/HER2- breast cancer,Phase 3,2023-10-02 00:00:00,"Phase 3 result presented at NAMS 2023 showed that younger age, non-visceral disease, prior tamoxifen and a longer total duration of AI use may be associated with higher baseline vaginal and/or vulvar symptomatology, noted October. 2, 2023.",14,LABEL_14
+PRAX,Early-seizure-onset SCN2A developmental and epileptic encephalopathy (DEE),Phase 3,2023-10-02 00:00:00,"Phase 3 results from preliminary analysis of PRAX-222 Part 1 showed 44% median reduction in seizures after three doses for SCN2A-gain-of-function pediatric patients, noted October 2, 2023.",14,LABEL_14
+NVTA,Early-seizure-onset SCN2A developmental and epileptic encephalopathy (DEE),Phase 3,2023-10-02 00:00:00,"Phase 3 results from preliminary analysis of PRAX-222 Part 1 showed 44% median reduction in seizures after three doses for SCN2A-gain-of-function pediatric patients, noted October 2, 2023.",14,LABEL_14
+ATAI,Treatment Resistant Depression,Phase 1,2023-10-02 00:00:00,"Phase 1 completed, noted October 2, 2023.",6,LABEL_6
+TAK,NSCLC with EGFR exon 20 insertion mutations,Phase 3,2023-10-02 00:00:00,"Phase 3 trial withdrawn voluntarily after the confirmatory trial, which did not meet its primary endpoint, noted October 2, 2023.",14,LABEL_14
+ATAI,Treatment Resistant Depression,Phase 1,2023-10-02 00:00:00,"Phase 1 data reported that treatment was well-tolerated with a favorable safety profile, and dose-dependent increases in exposure were observed, noted October 02, 2023.",6,LABEL_6
+NVS,IgA nephropathy (IgAN),Phase 3,2023-10-02 00:00:00,"Phase 3 data reported that met its pre-specified interim analysis primary endpoint, noted October 2, 2023.",14,LABEL_14
+LLY,Moderate-to-severe atopic dermatitis (AD),CRL,2023-10-02 00:00:00,"CRL issued October 2, 2023.",2,LABEL_2
+SNDX,Relapsed/refractory (R/R) acute leukemias,Phase 2,2023-10-02 00:00:00,"Phase 2 trial met its primary endpoint at the protocol-defined interim analysis stage with a complete remission (CR) or a CR with partial hematological recovery (CRh) rate of 23% among the 57 efficacy evaluable patients in the pooled KMT2Ar acute leukemia cohort, noted October 2, 2023.",10,LABEL_10
+ZVRA,Idiopathic hypersomnia (IH),Phase 2,2023-10-02 00:00:00,"Phase 2 interim data reported that marked improvements in patient-reported assessments of key IH symptoms from the open-label titration phase, including excessive daytime sleepiness, sleep inertia, and brain fog, noted October 2, 2023.",10,LABEL_10
+APLS,Paroxysmal Nocturnal Hemoglobinuria (PNH),Approved,2023-10-02 00:00:00,"FDA Approved on October 2, 2023.",0,LABEL_0
+PDSB,Cervical cancer,Phase 2a,2023-10-02 00:00:00,"Additional Phase 2a data to be reported at the American Society for Radiation Oncology (ASTRO 2023) demonstrated that patients treated with PDS0101 had greater clearance of cfDNA as compared to those treated with SOC, noted October 2, 2023.",12,LABEL_12
+ASND,Hypoparathyroidism,Phase 3,2023-10-02 00:00:00,"Phase 3 clinical trial data presented at ATA, showed that 81% of adults with chronic post-surgical hypoparathyroidism treated with TransCon PTH (palopegteriparatide) achieved independence from conventional calcium and active vitamin D therapy while maintaining normal serum calcium levels during the 26-week blinded portion of the trial, compared to 6% taking placebo, noted October 2, 2023.",14,LABEL_14
+MIRM,Cerebrotendinous xanthomatosis (CTX),Phase 3,2023-10-02 00:00:00,"Phase 3 data met the primary endpoint of reduction in bile alcohols (urine 23S-pentol) was highly statistically significant, noted October 2, 2023.",14,LABEL_14
+ANIP,"Acute exacerbations of multiple sclerosis, rheumatoid arthritis, systemic lupus erythematous and ulcerative colitis",Approved,2023-10-02 00:00:00,"1-ml vial approved October 2, 2023.",0,LABEL_0
+GALT,Non-alcoholic steatohepatitis (NASH) with cirrhosis,Phase 2/3,2023-10-03 00:00:00,"4th DSMB concluded that NAVIGATE can continue as designed, without modifications, noted October 3, 2023.",11,LABEL_11
+ALXO,2nd line or greater gastric/gastroesophageal junction cancer,Phase 2,2023-10-03 00:00:00,"Phase 2 data reported a confirmed overall response rate for evorpacept combination treatment was 52% compared to 22% for control treatment, noted October 3, 2023.",10,LABEL_10
+ACRS,Atopic dermatitis,Phase 2b,2023-10-03 00:00:00,"Phase 2b trial enrollment completed, noted October 3, 2023",13,LABEL_13
+IRON,Polycythemia vera (PV),Phase 1,2023-10-03 00:00:00,"Phase 1 initiated, noted October 3, 2023.",6,LABEL_6
+PPBT,Squamous cell carcinoma of the head & neck (SCCHN),Phase 1/2,2023-10-03 00:00:00,"Phase 1/2 data showed that 2 out of 4 SCCHN patients at the highest dose cohort demonstrated a confirmed partial response, noted October 3, 2023.",7,LABEL_7
+IMMX,Multiple myeloma,Phase 1/2,2023-10-03 00:00:00,"Phase 1b/2a updated data reported a 100% (9/9) overall response rate and 67% (6/9) complete response rate (MRD 10-5) observed in heavily pre-treated patients, noted October 3, 2023.",7,LABEL_7
+VRTX,Type 1 Diabetes,Phase 1/2,2023-10-03 00:00:00,"Phase 1/2 long term data reported that two patients with at least 1 year of follow-up met the criteria for the primary endpoint of elimination of severe hypoglycemic events (SHEs) and HbA1c <7.0%, noted October 3, 2023.",7,LABEL_7
+RGNX,Duchenne Muscular Dystrophy (DMD),Phase 1/2,2023-10-03 00:00:00,"Phase 1/2 additional data shared at the World Muscle Society Congress reported that in the patient aged 4.4 years old, RGX-202 microdystrophin expression was measured to be 38.8% compared to control, and in the patient aged 10.6 years old, RGX-202 microdystrophin expression was measured to be 11.1% compared to control, noted October 3, 2023.",7,LABEL_7
+BDRX,Recurrent Glioblastoma (GBM),Phase 1,2023-10-03 00:00:00,"Phase 1 Cohort A enrollment completed, noted October 3, 2023.",6,LABEL_6
+IPSEY,Glabellar and lateral canthal lines,CRL,2023-10-03 00:00:00,"CRL received October 3, 2023.",2,LABEL_2
+NVAX,Covid-19,Approved,2023-10-03 00:00:00,"EUA approved October 3, 2023.",0,LABEL_0
+NBTX,Head and Neck Cancer,Phase 1,2023-10-04 00:00:00,"Phase 1 final data presented at ASTRO reported an overall response rate (ORR) of 81.8% (36/44) with a complete response rate (CRR) of 63.6% (28/44), noted October 4, 2023.",6,LABEL_6
+VCYT,Prostate cancer,Phase 3,2023-10-04 00:00:00,"Phase 3 trial validation of a genomic classifier presented at the ASTRO meeting noting that only the Decipher Prostate risk score was independently associated with metastasis-free survival (MFS; HR 1.12, 95% CI) and distant metastasis (DM; sHR 1.22, 95% CI), compared to standard risk factors including Gleason score, T-stage and prostate-specific antigen (PSA) level, noted October 4, 2023.",14,LABEL_14
+IKT,Multiple System Atrophy (MSA),Phase 2,2023-10-04 00:00:00,"Orphan Drug Designation granted by FDA on October 4, 2023.",10,LABEL_10
+MYMD,Sarcopenia and frailty,Phase 2,2023-10-04 00:00:00,"Phase 2 new data showed statistically significant results across Cohort 4 (1050mg), noted October 4, 2023.",10,LABEL_10
+VIRX,Epstein Barr Virus-associated cancers,Phase 2,2023-10-04 00:00:00,"Phase 2 trial demonstrated overall and complete response rates of 40%; follow-up from the Phase 1b/2 study demonstrated median duration of response extended to 17.3 months, noted October 4, 2023.",10,LABEL_10
+PRTC,Ulcerative colitis (UC),Phase 2,2023-10-04 00:00:00,"Phase 2 dosing was initiated and FDA granted fast track designation (FTD), noted October 4, 2023.",10,LABEL_10
+RHHBY,Babies with pre-symptomatic spinal muscular atrophy (SMA),Phase 3,2023-10-04 00:00:00,"Phase 3 OLE met its primary endpoint with 80% of babies sitting without support for at least 5 seconds after 1 year of Evrysdi, noted October 4, 2023.",14,LABEL_14
+GANX,Parkinson's Disease,Phase 1,2023-10-04 00:00:00,"Phase 1 trial dosing commenced, noted October 4, 2023.",6,LABEL_6
+AKRO,Nonalcoholic Steatohepatitis,Phase 2b,2023-10-04 00:00:00,"Phase 2b results published at the Lancet Gastroenterology & Hepatology showed that both EFX doses achieved statistical significance on primary and secondary histopathology endpoints after 24 weeks, noted October 4, 2023.",13,LABEL_13
+MRK,Localized muscle-invasive urothelial carcinoma (MIUC),Phase 3,2023-10-05 00:00:00,"Phase 3 trial met one of its dual primary endpoints of disease-free survival (DFS), noted October 5, 2023.",14,LABEL_14
+OKYO,Dry Eye Disease,Phase 2,2023-10-05 00:00:00,"Phase 2 data reported a dropout rate at 5.4% and that treatment was well tolerated, noted October 5, 2023.",10,LABEL_10
+NBIX,Congenital Adrenal Hyperplasia (CAH) - children,Phase 3,2023-10-05 00:00:00,"Phase 3 trial met primary endpoint, noted October 5, 2023.",14,LABEL_14
+LGVN,Alzheimer's Disease,Phase 2a,2023-10-05 00:00:00,"Phase 2a topline data reported that trial met primary endpoints of safety across all study groups, noted October 5, 2023.",12,LABEL_12
+MVIR,Advanced hepatocellular carcinoma (HCC),Phase 2a,2023-10-05 00:00:00,"Phase 2a data reported that 3 patients achieved Partial Response and 10 patients Stable Disease, providing 17% Overall Response Rate (ORR) and 72% Disease Control Rate (DCR), noted October 5, 2023.",12,LABEL_12
+AMGN,Non-small cell lung cancer (NSCLC),BLA Filing,2023-10-05 00:00:00,"FDA Oncologic Drugs Advisory Committee (ODAC) voted 2-10 against the question of if the primary endpoint, progression-free survival (PFS) per blinded independent central review (BICR), be reliably interpreted in CodeBreaK200, noted October 5, 2023.",1,LABEL_1
+LCTX,Geographic atrophy (GA),Phase 1/2,2023-10-05 00:00:00,"Phase 1/2 results presented at EURETINA Congress reported that 5 patients had an average of 4.4 letter BCVA gain by 3 months and 12.8 letter BCVA gain by 1 year compared to baseline, noted October 5, 2023.",7,LABEL_7
+PPBT,2L metastatic pancreatic cancer (PDAC),Phase 1/2,2023-10-06 00:00:00,"Phase 1 biomarker data demonstrated that CM24 treatment significantly reduced the level of NET marker in patients' serum, noted October 6, 2023.",7,LABEL_7
+ARQT,Plaque psoriasis in children,Approved,2023-10-06 00:00:00,"Approved for treatment of children aged 6 - 11 on October 6, 2023.",0,LABEL_0
+OCS,Diabetic macular edema (DME),Phase 3,2023-10-06 00:00:00,"Phase 3 data presented at EURETINA noted that 6 times a day dosing of OCS-01 was a highly effective Loading Dose, noted October 6, 2023.",14,LABEL_14
+VTYX,Ulcerative Colitis (UC),Phase 2,2023-10-09 00:00:00,"Phase 2 top-line data results showed that at 60 mg achieved the primary endpoint of clinical remission with a high rate of complete endoscopic remission, noted on October 9, 2023.",10,LABEL_10
+COYA,Alzheimer’s Disease (AD),Phase 2,2023-10-09 00:00:00,"Phase 2 enrollment completed, noted October 9, 2023.",10,LABEL_10
+IMUX,Progressive Multiple Sclerosis,Phase 2,2023-10-09 00:00:00,"Phase 2 24-Week data from first half of patients shows improvements in biomarker NfL, Consistent throughout the overall population as well as all subtypes, noted October 9, 2023.",10,LABEL_10
+BBIO,Limb Girdle Muscular Dystrophy Type 2i (LGMD2i),Phase 2,2023-10-09 00:00:00,"Phase 2 long-term data at Month 21 demonstrate a well-tolerated safety profile, and stabilization in 10 meter walk test (10MWT), 100-m timed test (100mTT), and the North Star Assessment (NSAD) scores, noted October 9, 2023.",10,LABEL_10
+TNYA,Heart Failure with Preserved Ejection Fraction,Phase 1,2023-10-09 00:00:00,"Phase 1 data presented at HFSA demonstrated safety and tolerability in healthy participants with dose-proportional pharmacokinetics and robust target engagement, noted October 9, 2023.",6,LABEL_6
+ALNY,Wild-type ATTR amyloidosis patients with cardiomyopathy,CRL,2023-10-09 00:00:00,"CRL issued by the FDA on October 9, 2023. As a result of the CRL, the Company will no longer pursue an expanded indication for patisiran in the US.",2,LABEL_2
+ANAB,Generalized pustular psoriasis,Phase 3,2023-10-09 00:00:00,"Phase 3 top-line data met its primary endpoint in the study population achieving rapid clearance of pustulation, erythema and scaling through Week 4 after a single dose of 750mg IV imsidolimab. Top-line data also demonstrate a favorable safety and tolerability profile, noted October 9, 2023.",14,LABEL_14
+RNA,Myotonic dystrophy type 1 (DM1),Phase 1/2,2023-10-09 00:00:00,"Phase 1/2 enrollment into open label extension trial commenced August 2, 2022. Phase 1/2 new data demonstrated improvement in additional functional measures augmenting previously reported positive data that demonstrated improvements in functional assessments of myotonia (video hand opening time, or vHOT), strength (Quantitative Muscle Testing total score, or QMT) and mobility (10-meter walk run test, or 10mWRT and the Timed Up and Go test, or TUG)., noted October 9, 2023.",7,LABEL_7
+AKRO,Nonalcoholic steatohepatitis (NASH),Phase 2b,2023-10-10 00:00:00,"Phase 2b top line data showed that a trend was observed for the primary endpoint of fibrosis improvement at 36 weeks, with 22% and 24% of the 28mg and 50mg EFX-treated groups, respectively, compared with 14% for placebo, noted October 10, 2023.",13,LABEL_13
+BTAI,Solid Tumors,Phase 2,2023-10-10 00:00:00,"Phase 2 trial showed a median OS of 13.6 months and a 12-month survival rate of 56.5%., noted October 10, 2023.",10,LABEL_10
+CAPR,Duchenne Muscular Dystrophy (DMD),Phase 2,2023-10-10 00:00:00,"Phase 2 data presented at the World Muscle Society reported that the mean PUL 2.0 decline after 24-months of treatment with CAP-1002 was 2.8 points versus a 7.7-point decline on average observed over 24-months in the placebo, noted October 10, 2023.",10,LABEL_10
+BFRI,Actinic keratosis (AK),Approved,2023-10-10 00:00:00,"Approved October 10, 2023.",0,LABEL_0
+INO,HPV 6 and HPV 11-associated Recurrent respiratory papillomatosis,Phase 1/2,2023-10-10 00:00:00,"Phase 1/2 received feedback from the FDA that data could support INOVIO's submission of a BLA for review under the FDA's accelerated approval program. The FDA also advised that the company's previously planned Phase 3 trial would not be required to support this submission, noted October 10, 2023.",7,LABEL_7
+ATHX,Ischemic stroke,Phase 3,2023-10-10 00:00:00,"Phase 3 trial was insufficiently powered to achieve the primary endpoint, noted October 10, 2023.",14,LABEL_14
+GRTS,COVID-19 vaccine,Phase 1,2023-10-11 00:00:00,"Data presented at IDweek reported that treatment was well tolerated in both HIV-negative participants and PLWH irrespective of SARS-CoV-2 serostatus at baseline, October 11, 2023.",6,LABEL_6
+GRTS,COVID-19 booster (60+),Phase 1,2023-10-11 00:00:00,"Additional Phase 1 data reported at IDweek noted that durable binding and high neutralizing antibodies were induced and sustained for up to at least 12 months, noted October 11, 2023.",6,LABEL_6
+INCY,Vitiligo,Phase 2,2023-10-11 00:00:00,"Phase 2 trial initiated March 2021. Phase 2b study results shared at EADV reported that the total body depigmentation improvement from baseline as measured by the Total Vitiligo Area Scoring Index (T-VASI) at Week 52 for povorcitinib 15-to-75 mg, 45 mg, 75 mg and placebo-to-75 mg were 40.7%, 42.7%, 41.3% and 18.1%, respectively, noted October 11, 2023.",10,LABEL_10
+GRTS,COVID-19 vaccine,Phase 1,2023-10-11 00:00:00,"Phase 1 data reported that all doses were well tolerated in both HIV-negative participants and PLWH irrespective of SARS-CoV-2 serostatus at baseline, noted October 11, 2023.",6,LABEL_6
+RHHBY,Multiple sclerosis (MS) or primary progressive MS,Phase 3,2023-10-11 00:00:00,"Phase 3 data reported that treatment was comparable to IV infusion in providing rapid and sustained depletion of B cells and near-complete suppression of MRI lesion activity in the brain over 24 weeks, noted October 11, 2023.",14,LABEL_14
+HALO,Multiple sclerosis (MS) or primary progressive MS,Phase 3,2023-10-11 00:00:00,"Phase 3 data reported that treatment was comparable to IV infusion in providing rapid and sustained depletion of B cells and near-complete suppression of MRI lesion activity in the brain over 24 weeks, noted October 11, 2023.",14,LABEL_14
+RIGL,COVID-19,Phase 2/3,2023-10-11 00:00:00,"Phase 2/3 trial enrollment ceased based on the recommendations of DSMB, noting that here was an extremely low likelihood of fostamatinib providing benefits related to the primary outcome, noted October 11, 2023.",11,LABEL_11
+TPST,Hepatocellular carcinoma (HCC),Phase 1/2,2023-10-11 00:00:00,"Phase 1b/2 trial had a confirmed objective response rate of 30% for the TPST-1120 triplet arm versus 13.3% for the atezolizumab + bevacizumab control arm; duration of response (""DoR"") has not yet been reached, noted October 11, 2023.",7,LABEL_7
+PDSB,Metastatic Prostate Cancer,Phase 1,2023-10-11 00:00:00,"First in human safety and immune data presented at Cytokines reported a decrease in PSA levels, and that all doses of the combination were well-tolerated with one patient experiencing Grade 4 neutropenia, noted October 11, 2023.",6,LABEL_6
+PFE,BRAFV600E-mutant metastatic non-small cell lung cancer (NSCLC),Approved,2023-10-12 00:00:00,"Approved October 12, 2023.",0,LABEL_0
+TEVA,Inflammatory conditions,CRL,2023-10-12 00:00:00,"CRL received October 12, 2023.",2,LABEL_2
+ALVO,Inflammatory conditions,CRL,2023-10-12 00:00:00,"CRL received October 12, 2023.",2,LABEL_2
+LLY,Crohn's disease,Phase 3,2023-10-12 00:00:00,"Phase 3 trial met the co-primary and all major secondary endpoints, noted October 12, 2023.",14,LABEL_14
+CYT,"Solid tumors, Ovarian cancer",Phase 1,2023-10-12 00:00:00,"Additional Phase 1 data reported that two patients had a confirmed partial response, one additional patient achieved an unconfirmed partial response, seven patients had stable disease and one patient had progressive disease, noted October 12, 2023.",6,LABEL_6
+PMVP,Solid tumors,Phase 1/2,2023-10-12 00:00:00,"Phase 1/2 updated results presented at AACR-NCI-EORTC reported that the overall response rate (ORR) was 38% (6/16 evaluable patients) at the Recommended Phase 2 Dose (RP2D) of 2000 mg daily and 34% (13/38) in the efficacious dose range, noted October 12, 2023.",7,LABEL_7
+MRK,Solid tumors,Phase 1/2,2023-10-12 00:00:00,"Phase 1/2 updated results presented at AACR-NCI-EORTC reported that the overall response rate (ORR) was 38% (6/16 evaluable patients) at the Recommended Phase 2 Dose (RP2D) of 2000 mg daily and 34% (13/38) in the efficacious dose range, noted October 12, 2023.",7,LABEL_7
+RLAY,Cholangiocarcinoma (CCA),Phase 1,2023-10-12 00:00:00,"Phase 1 data from non-CCA expansion cohort presented at AACR-NCI-EORTC reported a 35% overall response rate (ORR), and nine of 26 patients experienced a partial response (PR), noted October 12, 2023.",6,LABEL_6
+INCY,Hidradenitis suppurativa,Phase 2,2023-10-12 00:00:00,"Phase 2 secondary analysis presented at EADV reported that a large proportion of patients who received any dose of povorcitinib from Day 1 achieved T VASI50 (37.0% 45.2%) and F VASI75 (48.4% 58.6%) responses at Week 52, noted October 12, 2023.",10,LABEL_10
+ENTA,Respiratory Syncytial Virus (community-acquired),Phase 2b,2023-10-12 00:00:00,"Phase 2b data shared at IDWeek 2023 reported that EDP-938 has a high barrier to clinical resistance, a single resistant mutation was detected in 1 of 37 sequenced EDP-938-treated participants October 12, 2023.",13,LABEL_13
+ONTX,Recessive Dystrophic Epidermolysis Bullosa-Associated Squamous Cell Carcinoma,Phase 2,2023-10-12 00:00:00,"Phase 2 data shared at the EADV reported that two patients achieved complete cutaneous responses of 12 months or more, one patient experienced metastatic disease progression, and one patient remains on study, noted October 12, 2023.",10,LABEL_10
+RHHBY,Multiple sclerosis (MS),Phase 2,2023-10-13 00:00:00,"Phase 2 showed that fenebrutinib crosses the blood-brain barrier with the potential to act directly on the chronic inflammation related to multiple sclerosis (MS). More than 90% relative reduction in new/enlarging T2 lesions and new T1 gadolinium-enhancing (Gd+) lesions with fenebrutinib beginning at eight week, noted October 13, 2023.",10,LABEL_10
+NUVL,ALK non-small cell lung cancer (NSCLC),Phase 1,2023-10-13 00:00:00,"Phase 1 trial showed preliminary signs of activity observed in heavily pre-treated patients with ALK-positive NSCLC, including in subgroups of patients who have previously received a 2nd generation ALK TKI and lorlatinib, have brain metastases, or have single or compound ALK resistance mutations, noted October 13, 2023.",6,LABEL_6
+LLY,Atopic Dermatitis,Phase 1,2023-10-13 00:00:00,"Phase 1b data presented at EADV 2023 showed dose-dependent efficacy reported across all endpoints for REZPEG demonstrating a rapid onset of action and continuing benefit for 36 weeks after 12-week treatment period, noted October 13, 2023.",6,LABEL_6
+NKTR,Atopic Dermatitis,Phase 1,2023-10-13 00:00:00,"Phase 1b data presented at EADV 2023 showed dose-dependent efficacy reported across all endpoints for REZPEG demonstrating a rapid onset of action and continuing benefit for 36 weeks after 12-week treatment period, noted October 13, 2023.",6,LABEL_6
+PFE,Ulcerative colitis,Approved,2023-10-13 00:00:00,"FDA Approved on October 13, 2023.",0,LABEL_0
+TRVI,Prurigo Nodularis (PN),Phase 2/3,2023-10-13 00:00:00,"Phase 2/3 long-term data also supports the continued effectiveness of Haduvio in reducing itch over 52 weeks for the participants who remained in the study, noted October 13, 2023.",11,LABEL_11
+ANIX,Ovarian Cancer,Phase 1,2023-10-13 00:00:00,"Phase 1 completed treatment of the first patient cohort, noted October 13, 2023.",6,LABEL_6
+ASLN,Atopic dermatitis (AD),Phase 2b,2023-10-13 00:00:00,"Phase 2b topline new data from a posthoc analysis of patients with severe disease (baseline EASI score at least 21), representing 63% of ITT patients, show monthly dosing with 600 mg eblasakimab for 16 weeks led to a 74.5% reduction in EASI score and EASI-75 of 53.6%, noted October 13, 2023.",13,LABEL_13
+RPTX,Solid Tumors,Phase 1,2023-10-13 00:00:00,"Phase 1 initial data from Module 1 and 2 presented at plenary session at AACR-NCI-EORTC International Conference suggested treatment with lunresertib in combination with camonsertib could result in efficacy outcomes for patients in the gynecological cancer setting. In this area, we're still seeing unmet patient needs despite current therapies, noted October 13, 2023.",6,LABEL_6
+IMUX,Relapsing-remitting multiple sclerosis (RMS),Phase 2,2023-10-13 00:00:00,"Phase 2 data presented at ECTRIMS reported that VidoCa was associated with a Nfl reduction from baseline up to W6 of -3% for the pooled 30 and 45mg VidoCa group compared to +2.5% for placebo, and up to W24 of -19% and +7%, respectively, noted October 13, 2023.",10,LABEL_10
+NCNA,Colorectal Cancer,Phase 1/2,2023-10-13 00:00:00,"Phase 1b/2 achieved a longer progression-free survival as compared to their first-line treatment with 5-FU-based Therapy, noted October 13, 2023.",7,LABEL_7
+NCNA,2L Colorectal cancer,Phase 2,2023-10-13 00:00:00,"Phase 2 patients recruiting well with no new safety signals, noted October 13, 2023.",10,LABEL_10
+INZY,ABCC6 deficiency,Phase 1/2,2023-10-13 00:00:00,"Phase 1/2 interim clinical data presented at ASBMR reported that treatment was generally well-tolerated on October 13, 2023.",7,LABEL_7
+ACRV,"Platinum-resistant ovarian,(PROC) endometrial, and urothelial cancers.",Phase 2,2023-10-13 00:00:00,"Phase 2 preliminary data shared at AACR-NCI-EORTC reported that ACR-368 that enables identification of responders to ACR-368 treatment, noted October 13, 2023",10,LABEL_10
+RVMD,Solid Tumors,Phase 1,2023-10-13 00:00:00,"Phase 1 preliminary data shared at AACR-NCI-EORTC reported a median time to response of 1.3 months, and median time on treatment of 3.5 months in NSCLC, with a median time to response of 1.4 months, and median time on treatment of 2.4 months in CRC, noted October 13, 2023.",6,LABEL_6
+KOD,Retinal vein occlusion (RVO),Phase 3,2023-10-13 00:00:00,"Phase 3 one year primary data from the Retina Society meeting reported that Tarcocimab treated patients had a ~30% higher chance of not requiring any additional doses versus aflibercep, noted October 13, 2023.",14,LABEL_14
+KOD,Treatment-Naive Wet Age-Related Macular Degeneration (AMD),Phase 3,2023-10-13 00:00:00,"Phase 3 data presented at the Retina Society meeting reported a favorable safety profile with low rates of intraocular inflammation and no cases of intraocular inflammation with vasculitis or vascular occlusion, noted October 13, 2023.",14,LABEL_14
+KOD,Diabetic Macular Edema (DME),Phase 3,2023-10-13 00:00:00,"Phase 3 data presented at the Retina Society meeting reported that 1/2 of patients achieved 6-month dosing at the primary endpoint, noted October 13, 2023.",14,LABEL_14
+NVCT,Ovarian Clear Cell Carcinoma,Phase 1,2023-10-13 00:00:00,"Phase 1 data presented at AACR-NCI-EORTC reported that NXP800 induced phosphorylation of eIF2a via activation of the stress activated kinase GCN2, noted October 13, 2023.",6,LABEL_6
+INCY,Atopic dermatitis (AD) in children (age ≥2 to <12 years),Phase 3,2023-10-13 00:00:00,"Phase 3 8- week analysis data shared at EADV in children (age ≥2 to <12 years) with atopic dermatitis (AD) achieved significant efficacy, as defined by the Investigator's Global Assessment-treatment success (IGA-TS), following eight weeks of treatment, noted October 13, 2023.",14,LABEL_14
+BDTX,Glioblastoma multiforme (GBM) and NSCLC,Phase 1,2023-10-14 00:00:00,"Phase 1 clinical data presented at AACR-NCI-EORTC meeting reported that five of the 13 patients with either intrinsic driver, acquired resistance or complex mutations had a confirmed partial response (PR), noted October 14, 2023.",6,LABEL_6
+MREO,Osteogenesis Imperfecta,Phase 2,2023-10-14 00:00:00,"Additional Phase 2 data reported that the annualized fracture rate across all 24 patients in the Phase 2 portion of the study was reduced by 67%, noted October 14, 2023.",10,LABEL_10
+RARE,Osteogenesis Imperfecta,Phase 2,2023-10-14 00:00:00,"Additional Phase 2 data reported that the annualized fracture rate across all 24 patients in the Phase 2 portion of the study was reduced by 67%, noted October 14, 2023.",10,LABEL_10
+ENTX,Osteoporosis,Phase 2,2023-10-14 00:00:00,"Phase 2 data presented at ASBMR showed that an increase in plasma ionized calcium should result in decreased secretion and plasma concentrations of endogenous PTH(1-84), noted October 14, 2023",10,LABEL_10
+TRVN,Epilepsy and other CNS disorders,Phase 1,2023-10-16 00:00:00,"Full safety and tolerability data showed that TRV045 was well tolerated with results generally consistent with prior first-in-human study, noted October 16, 2023.",6,LABEL_6
+IMUX,"Celiac disease, healthy volunteers",Phase 1,2023-10-16 00:00:00,"Phase 1 data reported that treatment has been well tolerated, with no systematic clinically relevant findings relative to safety and tolerability, noted October 16, 2023.",6,LABEL_6
+CLSD,Wet age-related macular degeneration,Phase 1/2,2023-10-16 00:00:00,"Phase 1/2a results demonstrated the key benefits targeting the site of disease at the back of the eye, noted October 16, 2023.",7,LABEL_7
+IKT,Parkinson’s disease,Phase 2,2023-10-16 00:00:00,"Phase 2 update showed that at the end of study timepoint, participants administered the 200 mg dose had a combined Part 2 and Part 3 score that was lower by an average of -8.7 points. By contrast, the combined placebo score increased by an average of +1.7 points, a -10.4 point spread between actively treated versus placebo participants, noted October 16, 2023.",10,LABEL_10
+CFRX,Gram-negative infections,Phase 1a,2023-10-16 00:00:00,"IND safety review completed by FDA on October 16, 2023.",8,LABEL_8
+ABBV,Crohn's disease,Phase 3,2023-10-16 00:00:00,"Phase 3 data reported that the trial met all primary and secondary endpoints, noted October 16, 2023.",14,LABEL_14
+BNOX,Social Anxiety Disorder (SAD),Phase 3,2023-10-16 00:00:00,End of Phase 2 meeting minutes resulted in favorable outcome for the company which confirmed agreement with the FDA on its Phase 3 clinical trial expected to commence in 1Q 2024.,14,LABEL_14
+AMGN,KRAS mutant non-small cell lung cancer (NSCLC),Phase 1/2,2023-10-16 00:00:00,"Phase 1/2 initial data reported that the confirmed objective response rate (ORR) was 25% (3/12) across efficacy-evaluable patients and seen in both KRAS G12C inhibitor resistant (14.3%; 1/7) and naïve (40%; 2/5) patients, noted October 16, 2023.",7,LABEL_7
+VSTM,KRAS mutant non-small cell lung cancer (NSCLC),Phase 1/2,2023-10-16 00:00:00,"Phase 1/2 initial data reported that the confirmed objective response rate (ORR) was 25% (3/12) across efficacy-evaluable patients and seen in both KRAS G12C inhibitor resistant (14.3%; 1/7) and naïve (40%; 2/5) patients, noted October 16, 2023.",7,LABEL_7
+NCNA,Solid tumors,Phase 2,2023-10-16 00:00:00,"Phase 1/2 part 2 for both as a monotherapy in solid tumors and in combination with the anti-PD-1 therapy pembrolizumab in patients with metastatic cutaneous melanoma showed that treatment has been well tolerated both as a monotherapy and in combination with pembrolizumab. Encouraging signs of efficacy, including tumor volume reductions and prolonged time on treatment have been observed in both the monotherapy and combination cohorts, noted October 16, 2023.",10,LABEL_10
+SNY,Hematological malignancies,Phase 1/2,2023-10-16 00:00:00,"Phase 1/2 data from ESMO abstract reported that 3/8 patients achieved complete remission (CR), noted October 16, 2023.",7,LABEL_7
+BMY,Stage IIB or IIC melanoma,Approved,2023-10-16 00:00:00,"Approved October 13, 2023.",0,LABEL_0
+IPHA,Hematological malignancies,Phase 1/2,2023-10-16 00:00:00,"Phase 1/2 data from ESMO abstract reported that 3/8 patients achieved complete remission (CR), noted October 16, 2023.",7,LABEL_7
+MOR,Crohn's disease,Phase 3,2023-10-16 00:00:00,"Phase 3 data reported that in the combination 54% of patients reached a clinical remission, noted October 16, 2023.",14,LABEL_14
+IPHA,Squamous Cell Carcinoma of the Head and Neck (SCCHN),Phase 2,2023-10-16 00:00:00,"Phase 2 results reported that D+M 1 partial response (PR) was recorded and stable disease (SD) was observed in 11 pts (26%), noted October 16, 2023.",10,LABEL_10
+OMER,IgA nephropathy,Phase 3,2023-10-16 00:00:00,"Phase 3 9-month data did not meet its primary endpoint, as a result Omeros will not submit an application for approval of narsoplimab in this indication and will discontinue the ARTEMIS-IGAN clinical trial, noted October 16, 2023.",14,LABEL_14
+JNJ,Crohn's disease,Phase 3,2023-10-16 00:00:00,"Phase 3 data reported that in the combination 54% of patients reached a clinical remission, noted October 16, 2023.",14,LABEL_14
+MRK,"Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer (NSCLC)",Approved,2023-10-16 00:00:00,"Approved on October 16, 2023.",0,LABEL_0
+RARE,Osteogenesis Imperfecta,Phase 2b,2023-10-16 00:00:00,"Phase 2b data demonstrated that treatment with setrusumab (UX143) significantly reduced the incidence of fractures in patients with osteogenesis imperfecta (Gr) with at least six months of follow-up and continues to demonstrate ongoing and meaningful improvements in lumbar spine bone mineral density (BMD), noted October 16, 2023.",13,LABEL_13
+APRE,Solid tumors,Phase 1/2,2023-10-16 00:00:00,"Phase 1/2a data presented at AACR-NCI-EORTC reported that no dose-limiting toxicities have been reported to date with persistent tumor-reducing effect, noted October 16, 2023.",7,LABEL_7
+REGN,Stage II to IV Cutaneous Squamous Cell Carcinoma (CSCC),Phase 2,2023-10-16 00:00:00,"Phase 2 data from ESMO reported a median duration of follow-up was 18.7 months, and 1 of 10 pts with MPR experienced recurrence, noted October 16, 2023.",10,LABEL_10
+APRE,Solid tumors,Phase 1/2,2023-10-16 00:00:00,"Phase 1/2a dose expansion cohort being on track to be initiated in 2Q 2024, additionally, data presented at AACR-NCI-EORTC reported that no dose-limiting toxicities have been reported to date with persistent tumor-reducing effect, noted October 16, 2023.",7,LABEL_7
+PBYI,Rb-deficient head and neck squamous cell cancer,Phase 1/2,2023-10-16 00:00:00,"Phase 1/2 data reported that the median PFS was 1.4 months, and the median overall survival (OS) was 13.5 months, noted October 16, 2023.",7,LABEL_7
+ZLAB,Non-small cell lung cancer (NSCLC),Phase 3,2023-10-16 00:00:00,"Phase 3 data from ESMO abstract reported that quality of life data showed no statistically significant difference between patients who received TTFields therapy together with standard systemic therapies, noted October 16, 2023.",14,LABEL_14
+NVCR,Non-small cell lung cancer (NSCLC),Phase 3,2023-10-16 00:00:00,"Phase 3 data from ESMO abstract reported that quality of life data showed no statistically significant difference between patients who received TTFields therapy together with standard systemic therapies, noted October 16, 2023.",14,LABEL_14
+MLTX,Hidradenitis suppurativa,Phase 2,2023-10-16 00:00:00,"Phase 2 24-week topline data reported that 57% of patients continuously treated with 120mg achieved a HiSCR75 response and 38% achieved HiSCR90, noted October 16, 2023.",10,LABEL_10
+VECT,Short bowel syndrome - colon-in-continuity,Phase 2,2023-10-16 00:00:00,"Additional Phase 2 data reported that 33% of the patients achieving clinical response and PS volume reduction reached a statistically significant 40% at week 24 and the effect was maintained with a 52% volume reduction at week 52, noted October 16, 2023.",10,LABEL_10
+PRLD,Solid tumors and hematological malignancies,Phase 1,2023-10-16 00:00:00,"Phase 1 data reported that 8 (27.6%) patients had stable disease (SD) as the best response and the median PFS was 1.25 months, noted October 16, 2023.",6,LABEL_6
+EVLO,"Psoriasis, healthy volunteers",Phase 2,2023-10-17 00:00:00,"Phase 2 study did not achieve its primary endpoint, noted October 17, 2023.",10,LABEL_10
+GMDA,Follicular and diffuse large B cell lymphomas,Phase 1,2023-10-17 00:00:00,"Phase 1 data showed promising early evidence of anti-tumor activity in patients with relapsed/refractory B cell non-Hodgkin lymphoma, noted October 16, 2023.",6,LABEL_6
+GLUE,MYC-driven solid tumors,Phase 1/2,2023-10-17 00:00:00,"Phase 1/2 initial data study demonstrated favorable tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles in heavily pre-treated patients with lung and high-grade neuroendocrine cancers., noted October 17, 2023",7,LABEL_7
+BOLT,Solid Tumors,Phase 1/2,2023-10-17 00:00:00,"Phase 1/2 initiated, noted October 17, 2023.",7,LABEL_7
+ARDX,Serum phosphorus - chronic kidney disease (CKD) on dialysis,Approved,2023-10-17 00:00:00,"Approved October 17, 2023.",0,LABEL_0
+BMY,Non-metastatic non-small cell lung cancer,Phase 3,2023-10-17 00:00:00,"Phase 3 reported patients treated with neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo, the risk of disease recurrence, progression or death was reduced by 42%, noted October 17, 2023.",14,LABEL_14
+BMEA,Acute myeloid leukemia (AML),Phase 1,2023-10-17 00:00:00,"Phase 1 dosing initiated, noted October 17, 2023.",6,LABEL_6
+BMY,Urothelial carcinoma,Phase 3,2023-10-17 00:00:00,"Phase 3 data presented at ESMO reported that Opdivo in combination with cisplatin-based chemotherapy reduced the risk of death by 22%, demonstrating a median OS of 21.7 months vs. 18.9 months with chemotherapy alone, noted October 17, 2023.",14,LABEL_14
+VIGL,Healthy volunteers,Phase 1,2023-10-17 00:00:00,"Phase 1 trial dosing initiated, noted October 17, 2023.",6,LABEL_6
+VKTX,Obesity,Phase 1,2023-10-18 00:00:00,"Phase 1 data demonsted that 28 days of once-weekly treatment with VK2735 resulted in reductions in subjects' liver fat content and plasma lipid levels, both from baseline and as compared to placebo, noted October 18, 2023.",6,LABEL_6
+TAK,Complex Crohn's Perianal Fistulas (CPF),Phase 3,2023-10-18 00:00:00,"Phase 3 trial did not meet its primary endpoint, noted October 18, 2023.",14,LABEL_14
+RHHBY,Non-small cell lung cancer (NSCLC),Phase 3,2023-10-18 00:00:00,"Phase 3 data reported that treatment reduces the risk of disease recurrence or death by 76%, noted October 18, 2023.",14,LABEL_14
+PCVX,Invasive Pneumococcal Disease (IPD),Phase 1/2,2023-10-19 00:00:00,"IND cleared by FDA, noted October 19, 2023",7,LABEL_7
+MRK,HER2-positive gastric or Gastroesophageal junction (GEJ) adenocarcinoma,Phase 3,2023-10-20 00:00:00,"Phase 3 trial data presented at ESMO demonstrated a statistically significant PFS improvement in advanced HER2-positive gastric or GEJ adenocarcinoma in tumors expressing PD-L1 (Combined Positive Score [CPS] ≥1) compared to trastuzumab and chemotherapy alone October 20, 2023.",14,LABEL_14
+AZN,Anaemia of myelodysplastic syndromes (MDS),Phase 3,2023-10-20 00:00:00,"Phase 3 data presented at ESMO reported that treatment demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of pathologic complete response (pCR) versus neoadjuvant chemotherapy alone, noted October 20, 2023.",14,LABEL_14
+FGEN,Anaemia of myelodysplastic syndromes (MDS),Phase 3,2023-10-20 00:00:00,"Phase 3 data presented at ESMO reported that treatment demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of pathologic complete response (pCR) versus neoadjuvant chemotherapy alone, noted October 20, 2023.",14,LABEL_14
+MRK,"Resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC)",Phase 3,2023-10-20 00:00:00,"Phase 3 data presented at ESMO 23 demonstrated statistically significant improvement in overall survival versus neoadjuvant placebo plus chemotherapy, noted October 20, 2023.",14,LABEL_14
+PFE,"Meningococcal Vaccine, Adolescents",Approved,2023-10-20 00:00:00,"FDA approved on October 20, 2023.",0,LABEL_0
+MRK,"High-Risk, Early-Stage ER+/HER2- Breast Cancer",Phase 3,2023-10-20 00:00:00,"Phase 3 data presented at ESMO reported that treatment significantly improved pCR rate compared to neoadjuvant placebo plus chemotherapy (24.3% vs. 15.6%, respectively), noted October 20, 2023.",14,LABEL_14
+SNY,Chronic spontaneous urticaria (CSU),CRL,2023-10-20 00:00:00,"CRL issued by the FDA, noted October 20, 2023.",2,LABEL_2
+BHC,Acne vulgaris,Approved,2023-10-20 00:00:00,"Approved on October 20, 2023.",0,LABEL_0
+AMAM,PSMA Expressing Tumors,Phase 1,2023-10-20 00:00:00,"Phase 1 data presented at ESMO reported that 52% (12/23) of patients experienced a ≥50% PSA reduction, and ≥90% PSA reduction observed in 6% (1/16) and 36% (5/14) of patients at 1.4 mg/kg (Cohort 4) and 2.0 mg/kg (Cohort 6), respectively, noted October 20, 2023.",6,LABEL_6
+ZYME,Gastric/gastroesophageal junction adenocarcinoma (G/GEJC),Phase 1/2,2023-10-20 00:00:00,"Phase 1b/2 data presented at ESMO reported that the confirmed objective response rate by investigator (INV) was 75.8% and median progression-free survival was 16.7 months, noted October 20, 2023.",7,LABEL_7
+MRTX,Non-Small Cell Lung Cancer (NSCLC),Phase 2,2023-10-20 00:00:00,"Phase 2 data presented at ESMO 2023 reported that in patients with PD-L1 TPS ≥50%, adagrasib + pembrolizumab demonstrated a higher response rate (63%) than expected with pembrolizumab monotherapy (39–45%3,4), noted October 20, 2023.",10,LABEL_10
+BGNE,Gastric/gastroesophageal junction adenocarcinoma (G/GEJC),Phase 1/2,2023-10-20 00:00:00,"Phase 1b/2 data presented at ESMO reported that the confirmed objective response rate by investigator (INV) was 75.8% and median progression-free survival was 16.7 months, noted October 20, 2023.",7,LABEL_7
+REGN,Chronic spontaneous urticaria (CSU),CRL,2023-10-20 00:00:00,"CRL issued by the FDA, noted October 20, 2023.",2,LABEL_2
+AGEN,"Advanced Solid tumors, Colorectal cancer",Phase 1b,2023-10-21 00:00:00,"Phase 1b data presented at ESMO reported an overall response rate (ORR) of 24% was observed, compared to 2.8% reported with standard of care (SOC), and a 12-month overall survival (OS) of 74% and median OS (mOS) not yet reached, noted October 21, 2023.",9,LABEL_9
+BMY,Stage IIA to IIIB non-small cell lung cancer (NSCLC),Phase 3,2023-10-21 00:00:00,"Phase 3 data presented at ESMO reported that NIVO + chemo/NIVO improved pCR rates (25.3% vs 4.7%; odds ratio, 6.64 [95% CI, 3.40–12.97]) and MPR rates (35.4% vs 12.1%; odds ratio: 4.01 [2.48–6.49]) vs chemo/PBO, noted October 21, 2023.",14,LABEL_14
+KURA,Head and neck squamous cell carcinomas (HNSCC),Phase 2,2023-10-21 00:00:00,"Phase 2 data presented at ESMO reported that the Tipifarnib ORR was higher in 2L setting than 3L+ setting (29% vs. 15%), noted October 21, 2023.",10,LABEL_10
+BGNE,Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma,Phase 3,2023-10-21 00:00:00,"Phase 3 data presented at ESMO reported that OS in the TIS arm was significantly improved compared with the PBO arm in the ITT population (median OS: 15.0 mo vs 12.9 mo, respectively; HR=0.80 [95% CI: 0.70, 0.92]; 1-sided P=0.0011), noted October 21, 2023.",14,LABEL_14
+BGNE,Hepatocellular Carcinoma (HCC),Phase 2,2023-10-21 00:00:00,"Phase 2 poster presented at ESMO reported that NV-assessed ORR was 35.5% with O+T+B vs. 37.5% with T+B, noted October 21, 2023.",10,LABEL_10
+BGNE,Esophageal Squamous Cell Carcinoma (ESCC),Phase 2,2023-10-21 00:00:00,"Phase 2 data presented at ESMO reported that INV-assessed ORR was 30.6% with O+T vs. 20.6% with P+T; hazard ratio (HR) of INV-assessed PFS was 0.93, noted October 21, 2023.",10,LABEL_10
+PFE,"Claudin-18 isoform 2-positive (CLDN18.2+), HER2−, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma",Phase 3,2023-10-21 00:00:00,"Phase 3 data presented at ESMO reported that median PFS was 11.0 vs 8.9 mo and median OS was 18.2 vs 15.6 mo, noted October 21, 2023.",14,LABEL_14
+ALPMY,"Claudin-18 isoform 2-positive (CLDN18.2+), HER2−, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma",Phase 3,2023-10-21 00:00:00,"Phase 3 data presented at ESMO reported that median PFS was 11.0 vs 8.9 mo and median OS was 18.2 vs 15.6 mo, noted October 21, 2023.",14,LABEL_14
+LLY,Medullary thyroid cancer (MTC),Phase 3,2023-10-21 00:00:00,"Phase 3 data presented at ESMO reported that selpercatinib demonstrated superior PFS vs control in the ITT-pembro (HR: 0.465, 95% CI: 0.309, 0.699; p-value: 0.0002) and ITT populations (HR: 0.482, 95% CI: 0.331, 0.700; p-value: 0.0001), noted October 21, 2023.",14,LABEL_14
+ARVN,Castration-resistant prostate cancer (CRPC),Phase 1/2,2023-10-22 00:00:00,"Updated data from the ongoing Phase 1/2 trial presented at ESMO reported a median rPFS of 11.1 months in patients harboring AR 878/875 mutations and without co-occurring AR L702H mutations, and PSA50 rates of 54% in patients with tumors harboring AR 878/875 mutations and without co-occurring AR L702H, noted October 22, 2023.",7,LABEL_7
+OLMA,"HR+, HER2- Breast Cancer",Phase 1/2,2023-10-22 00:00:00,"Phase 1/2 monotherapy data presented at ESMO reported that the median PFS was 4.6 months with a CBR of 40%; in patients with ESR1 mutations at baseline, the median PFS was 5.6 months with a CBR of 52%, noted October 22, 2023.",7,LABEL_7
+BMY,Melanoma,Phase 2/3,2023-10-22 00:00:00,"Phase 2/3 data presented at ESMO reported that response to NIVO+RELA was associated with increased LAG-3+ CD4+ T cells at week 4, but on-treatment modulation of peripheral CD8+ T cells was not associated with NIVO+RELA efficacy, noted October 22, 2023.",11,LABEL_11
+RVMD,Advanced Solid Tumors,Phase 1b,2023-10-22 00:00:00,"Phase 1/1b data shared at ESMO reported that the objective response rate was 38 percent, with one patient achieving a complete response (CR) as a best response and 14 patients achieving a partial response, noted October 22, 2023.",9,LABEL_9
+FHTX,Metastatic Uveal Melanoma (mUM),Phase 1,2023-10-22 00:00:00,"Phase 1 clinical data presented at ESMO reported that 1 patient treated at the 7.5 mg QD continuous dose level experienced a DLT of Grade 3 keratitis, noted October 22, 2023.",6,LABEL_6
+RYZB,Gastroenteropancreatic neuroendocrine tumors,Phase 1b,2023-10-22 00:00:00,"Phase 1b data presented at ESMO reported that the confirmed ORR was 29.4%, with all five patients having a confirmed PR, noted October 22, 2023.",9,LABEL_9
+BGNE,Cervical Cancer (CC),Phase 2,2023-10-22 00:00:00,"Phase 2 data presented at ESMO reported that the ORR was 22.5%, with 13 complete responses; 76.8% had a durable response of ≥6 mo, noted October 22, 2023.",10,LABEL_10
+EPIX,Metastatic castration-resistant prostate cancer (mCRPC),Phase 1,2023-10-22 00:00:00,"Phase 1 updated data presented at ESMO reported a PSA50 of 88%, PSA90 of 69%, and PSA <0.2 ng/mL of 56%, noted October 22, 2023.",6,LABEL_6
+IOBT,Metastatic solid tumors,Phase 2,2023-10-23 00:00:00,"Additional Phase 2 data presented at ESMO reported that 10 out of 18 evaluable NSCLC patients (56%) had achieved a partial response as their best overall response and 3 out of 6 evaluable SCCHN patients had achieved partial response as their best overall response, noted October 23, 2023.",10,LABEL_10
+MRUS,Solid tumors - NRG1,Phase 1/2,2023-10-23 00:00:00,"Phase 1/2 data update presented at ESMO showed a 37% ORR and 14.9 months median DOR in 78 evaluable NRG1+ NSCLC patients and 42% ORR and 9.1 months median DOR in 33 evaluable NRG1+ PDAC patients. Sufficient clinical data expected in 1H 2024 to support potential BLA submissions, noted October 23, 2023.",7,LABEL_7
+HARP,Small cell lung cancer,Phase 1/2,2023-10-23 00:00:00,"Phase 1/2 data from ESMO reported a confirmed response rate 35% (11/31), across all tumor types and patient cohorts treated with 1 mg priming dose, and a 32% (6/19) confirmed response rate in patients with small cell lung cancer (SCLC), noted October 23, 2023.",7,LABEL_7
+ALPMY,Untreated locally advanced or metastatic urothelial cancer (la/mUC),Phase 3,2023-10-23 00:00:00,"Phase 3 data presented at ESMO reported a median OS of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months in the chemotherapy arm, significantly prolonged OS, reducing the risk of death by 53% compared to treatment with chemotherapy, noted October 23, 2023.",14,LABEL_14
+MRK,Untreated locally advanced or metastatic urothelial cancer (la/mUC),Phase 3,2023-10-23 00:00:00,"Phase 3 data presented at ESMO reported a median OS of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months in the chemotherapy arm, significantly prolonged OS, reducing the risk of death by 53% compared to treatment with chemotherapy, noted October 23, 2023.",14,LABEL_14
+SGEN,Untreated locally advanced or metastatic urothelial cancer (la/mUC),Phase 3,2023-10-23 00:00:00,"Phase 3 data presented at ESMO reported a median OS of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months in the chemotherapy arm, significantly prolonged OS, reducing the risk of death by 53% compared to treatment with chemotherapy, noted October 23, 2023.",14,LABEL_14
+GMAB,Cervical Cancer,Phase 3,2023-10-23 00:00:00,"Additional data presented at ESMO that the overall survival (OS) was statistically significantly prolonged with TIVDAK, demonstrating a 30% reduction in the risk of death compared with chemotherapy, noted October 22, 2023.",14,LABEL_14
+EXEL,Advanced Neuroendocrine Tumors,Phase 3,2023-10-23 00:00:00,"Phase 3 data from ESMO 23 reported that the trial met the primary objective for each cohort, demonstrating that cabozantinib provided dramatic improvements in median progression-free survival (PFS) for the patients in the pNET and epNET cohorts, noted October 23, 2023.",14,LABEL_14
+ADXS,Desmoid tumors,Phase 2/3,2023-10-23 00:00:00,"Phase 2 data presented at ESMO showed that 1.2 mg once daily treatment achieved Overall Response Rate of 83% in the evaluable population, AL102 1.2 mg once daily treatment resulted in 88% reduction in tumor volume and 85% reduction in T2W signal intensity, noted October 23, 2023.",11,LABEL_11
+AYLA,Desmoid tumors,Phase 2/3,2023-10-23 00:00:00,"Phase 2 data presented at ESMO showed that 1.2 mg once daily treatment achieved Overall Response Rate of 83% in the evaluable population, AL102 1.2 mg once daily treatment resulted in 88% reduction in tumor volume and 85% reduction in T2W signal intensity, noted October 23, 2023.",11,LABEL_11
+AZN,Untreated advanced or metastatic triple negative breast cancer (TNBC),Phase 1/2,2023-10-23 00:00:00,"Phase 1b/2 data reported a confirmed objective response rate (ORR) of 79% (95% confidence interval [CI]: 67-88) including six complete responses (CRs) and 43 partial responses (PRs), noted October 23, 2023.",7,LABEL_7
+TOVX,Head and Neck Squamous Cell Carcinoma,Phase 1,2023-10-23 00:00:00,"Phase 1 data shared at ESMO 23 showed enhanced patient survival, correlating with VCN-01 mediated increases in the CPS score, a key determinant of outcomes with anti-PD-(L)1 checkpoint inhibitor therapies, noted October 23, 2023.",6,LABEL_6
+AZN,Endometrial cancer (EC),Phase 3,2023-10-23 00:00:00,"Phase 3 results presented at ESMO reported statistically significant and clinically meaningful PFS benefit vs CP in the ITT population, with the interim OS data being immature (27.7%) yet with a trend towards benefit, noted October 21, 2023.",14,LABEL_14
+ARVN,Metastatic castration-resistant prostate cancer (mCRPC),Phase 1/2,2023-10-23 00:00:00,"Phase 1/2 data presented at ESMO reported a PSA50 of 41% in patients with tumors harboring any AR LBD mutation, and a PSA50 of 50% in patients with any tumor harboring an AR L702H mutation, noted October 23, 2023.",7,LABEL_7
+MRK,Metastatic solid tumors,Phase 2,2023-10-23 00:00:00,"Additional Phase 2 data presented at ESMO reported that 10 out of 18 evaluable NSCLC patients (56%) had achieved a partial response as their best overall response and 3 out of 6 evaluable SCCHN patients had achieved partial response as their best overall response, noted October 23, 2023.",10,LABEL_10
+SGEN,Cervical Cancer,Phase 3,2023-10-23 00:00:00,"Additional data presented at ESMO that the overall survival (OS) was statistically significantly prolonged with TIVDAK, demonstrating a 30% reduction in the risk of death compared with chemotherapy, noted October 22, 2023.",14,LABEL_14
+MRNA,"Personalized cancer vaccine, high-risk melanoma",Phase 2,2023-10-23 00:00:00,"Phase 2 additional data presented at ESMO reported that local recurrence was more common in MRs; MNRs had more distant events. This trend was supported by stronger separation in DMFS vs RFS between MRs and MNRs, noted October 23, 2023.",10,LABEL_10
+AZN,Non-small cell lung cancer (NSCLC),Phase 3,2023-10-23 00:00:00,"Phase 3 reduced the risk of disease progression or death by 25% in overall population and by 37% in patients with non-squamous tumors , noted October 23, 2023.",14,LABEL_14
+MRK,Ovarian cancer,Phase 1,2023-10-23 00:00:00,"Phase 1 data presented at ESMO reported that the confirmed overall response rate in patients with measurable disease was 38% (13 of 34): 67% (including 1 CR) at 4.8 mg/kg, 33% (5/15) at 6.4 mg/kg, and 31% (4/13) at 8.0 mg/kg, with two patients with unconfirmed partial responses were still on treatment, noted October 23, 2023.",6,LABEL_6
+BMY,Non-small cell lung cancer (NSCLC),Phase 3,2023-10-23 00:00:00,"Phase 3 data presented at ESMO reported that 3-y EFS and OS rates were 72% vs 47% and 85% vs 66%, respectively, noted October 23, 2023.",14,LABEL_14
+BNTX,Solid tumors,Phase 1/2,2023-10-23 00:00:00,"Phase 1/2 additional data presented at ESMO demonstrated that the application of CARVac increases the persistence of the adoptively transferred autologous CAR-T cells, noted October 23, 2023.",7,LABEL_7
+BGNE,Stage II-IIIA non-small cell lung cancer (NSCLC),Phase 3,2023-10-23 00:00:00,"Phase 3 data presented at ESMO reported that MPR & pCR rates were significantly improved with TIS + CT vs CT, noted October 23, 2023.",14,LABEL_14
+AZN,"HR Positive, HER2 Negative Breast Cancer",Phase 3,2023-10-23 00:00:00,"Phase 3 data presented at ESMO showed reduction of the risk of disease progression or death by 37%, providing a 2-month median PFS benefit, and was well tolerated in post-endocrine therapy setting, noted October 23, 2023.",14,LABEL_14
+NVS,Metastatic castration-resistant prostate cancer (mCRPC),Phase 3,2023-10-23 00:00:00,"Phase 3 trial met its primary endpoint with a clinically meaningful and statistically significant benefit in radiographic progression-free survival, noted October 23, 2023.",14,LABEL_14
+AZN,Multiple HER2-expressing advanced solid tumors,Phase 2,2023-10-23 00:00:00,"Phase 2 data presented at ESMO 23 continued to demonstrate clinically meaningful and durable responses with a a median progression-free survival of 6.9 months and median overall survival of 13.4 months in the overall trial population, noted October 23, 2023.",10,LABEL_10
+IBRX,BCG-Unresponsive Bladder Cancer Carcinoma,BLA Filing,2023-10-23 00:00:00,"BLA Resubmitted to the FDA, noted October 23, 2023.",1,LABEL_1
+BOLT,"HER2-Expressing Solid Tumors, gastric cancer, including gastroesophageal junction cancer",Phase 2,2023-10-23 00:00:00,"Phase 2 updated safety data presented at ESMO supports the selection of 20 mg/kg q2w as the recommended Phase 2 dose (RP2D), noted October 23, 2023.",10,LABEL_10
+STRO,Ovarian and Endometrial Cancer,Phase 1,2023-10-23 00:00:00,"Additional Phase 1 data reported that a confirmed partial response (PR) was seen in 29% of patients, and the Disease Control Rate (DCR) was 86%, noted October 23, 2023.",6,LABEL_6
+REGN,Stage II to IV resectable cutaneous squamous cell carcinoma (CSCC),Phase 2,2023-10-23 00:00:00,"Phase 2 data from ESMO 23 reported a 89% event-free survival rate at one year, and no disease recurrence among patients who achieved a pCR (n=40), noted October 23, 2023.",10,LABEL_10
+PDSB,Head and neck cancer,Phase 2,2023-10-23 00:00:00,"Phase 2 data presented at ESMO reported that the combination of PDS0101 and KEYTRUDA resulted in increased polyfunctionality reflected in T cells expressing 5 or more cytokines, noted October 23, 2023.",10,LABEL_10
+ORIC,Tumors - EGFR/HER2 Exon 20 Inhibitor,Phase 1b,2023-10-23 00:00:00,"Phase 1b initial data presented at ESMO reported responses observed in 2 of 3 EGFR exon 20 patients previously treated with amivantamab (67% ORR), including a confirmed complete response, note October 23, 2023.",9,LABEL_9
+GLTO,Non-small cell lung cancer (NSCLC),Phase 2a,2023-10-23 00:00:00,"Phase 2a data reported that the objective tumor responses (defined as partial responses per RECIST criteria 1.1) were observed in three of five patients (60%) who received GB1211 for at least three weeks, noted October 23, 2023",12,LABEL_12
+RHHBY,Non-small cell lung cancer (NSCLC),Phase 2a,2023-10-23 00:00:00,"Phase 2a data reported that the objective tumor responses (defined as partial responses per RECIST criteria 1.1) were observed in three of five patients (60%) who received GB1211 for at least three weeks, noted October 23, 2023",12,LABEL_12
+BMRN,Children under age 5 with Achondroplasia,Approved,2023-10-23 00:00:00,"Approved October 23, 2023.",0,LABEL_0
+MRK,"Personalized cancer vaccine, high-risk melanoma",Phase 2,2023-10-23 00:00:00,"Phase 2 additional data presented at ESMO reported that local recurrence was more common in MRs; MNRs had more distant events. This trend was supported by stronger separation in DMFS vs RFS between MRs and MNRs, noted October 23, 2023.",10,LABEL_10
+QNRX,Netherton Syndrome (NS),Phase 1,2023-10-24 00:00:00,"Phase 1 data from 6 subjects demonstrated well defined efficacy signals across a number of study endpoints, noted October 24, 2023.",6,LABEL_6
+IMTX,Solid tumors,Phase 1b,2023-10-24 00:00:00,"FDA Granted RMAT on October 24, 2023.",9,LABEL_9
+AXSM,Agitation in patients with Alzheimer’s disease (AD),Phase 3,2023-10-24 00:00:00,"Phase 3 results shared at the CTAD demonstrated rapid and sustained clinical response in patients with ADA during the open-label AXS-05 treatment. During the placebo-controlled randomized withdrawal phase, AXS-05 statistically significantly delayed the time to relapse of agitation symptoms as compared to placebo, noted October 24, 2023.",14,LABEL_14
+MRNA,COVID-19,Phase 3,2023-10-24 00:00:00,"Phase 3 trial of mRNA-1083 in adults 50 years initiated, noted October 24, 2023.",14,LABEL_14
+BMY,Progressive pulmonary fibrosis (PPF),Phase 2,2023-10-24 00:00:00,"Breakthrough Therapy Designation (BTD) granted by FDA on October 24, 2023.",10,LABEL_10
+RNAZ,Metastatic solid tumors,Phase 1a,2023-10-24 00:00:00,"Phase 0 preliminary data showed that radioactivity consistent with accumulation of TTX-MC138 was detected by noninvasive imaging in the regions of the metastatic lesions previously identified by fluorodeoxyglucose (FDG)/positron emission tomography (PET) (FDG/PET), noted October 24, 2023.",8,LABEL_8
+IMMP,Solid tumors,Phase 1,2023-10-24 00:00:00,"Phase 1 additional efficacy and tolerability data reported at ESMO showed strong 71.4% Overall Response Rate, 90.5% Disease Control Rate, 10.1-month median Progression Free Survival (PFS), and median Overall Survival (OS) that has not been reached, despite 81% of patients having low or negative PD-L1 expression, noted October 24, 2023.",6,LABEL_6
+EFTR,relapsed/refractory Acute Myeloid Leukemia (AML),Phase 1,2023-10-24 00:00:00,"Phase 1 initiated, noted October 24, 2023.",6,LABEL_6
+JNJ,Non- Small Cell Lung Cancer,Phase 3,2023-10-24 00:00:00,"Phase 3 data presented at ESMO reported that PFS was significantly improved with ami-chemo (HR, 0.48; 95% CI, 0.36–0.64) and ami-laz-chemo (HR, 0.44; 95% CI, 0.35–0.56) vs chemo (median PFS, 6.3 and 8.3 vs 4.2 mo), noted October 24, 2023.",14,LABEL_14
+JNJ,GFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer,Phase 3,2023-10-24 00:00:00,"Phase 3 data presented at ESMO reported ami+laz showed a 30% reduction in the risk for disease progression or death vs osi, with median PFS of 23.7 mo, and an ORR of 86%, noted October 24, 2023.",14,LABEL_14
+JNJ,High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC),Phase 2b,2023-10-24 00:00:00,"Phase 2b data presented at ESMO reported that centrally confirmed CR was achieved in 23/30 pts, noted October 24, 2023.",13,LABEL_13
+INMB,Neuroinflammation caused by Alzheimer’s disease,Phase 2,2023-10-24 00:00:00,"Phase 2 presentation at CTAD reported that XPro was associated with dose-dependent improvement in neurology-related proteins, noted October 24, 2023.",10,LABEL_10
+JNJ,Non-small cell lung cancer,Phase 3,2023-10-24 00:00:00,"Phase 3 data presented at ESMO reported that the median PFS was 11.4 months and the ORR was 73%, noted October 24, 2023.",14,LABEL_14
+MGTX,Xerostomia,Phase 1,2023-10-24 00:00:00,"Phase 1 OLE data presented at ESGCT showed that dosing was safe and well-tolerated at all dose levels, with no treatment-related serious adverse events or dose limiting toxicity, noted October 24, 2023.",6,LABEL_6
+FRLN,Gaucher disease,Phase 1/2,2023-10-25 00:00:00,"Phase 1/2 results shared at the ESGCT reported no infusion reactions and no serious adverse events, noted October 25, 2023.",7,LABEL_7
+GSK,"Respiratory syncytial virus (RSV) disease, Vaccine",Phase 3,2023-10-25 00:00:00,"Phase 3 trial met its co-endpoint, eliciting an immune response, noted October 25, 2023.",14,LABEL_14
+SAVA,Mild-to-Moderate Alzheimer's Disease,Phase 3,2023-10-25 00:00:00,"Phase 3 MRI data suggested that simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities, or ARIA. MRIs were all analyzed for ARIA by board-certified neuroradiologists, noted October 25, 2023.",14,LABEL_14
+BIIB,Mild Alzheimer's disease,Phase 1b,2023-10-25 00:00:00,"Phase 1b data presented at CTAD showed favorable trends reported for the high-dose groups on multiple measures of cognition and function, noted October 25, 2023.",9,LABEL_9
+ALNY,Alzheimer's Disease and Cerebral Amyloid Angiopathy,Phase 1,2023-10-25 00:00:00,"Phase 1 achieve sustained pharmacodynamic activity up to 10 months after administration, noted October 25, 2023.",6,LABEL_6
+BBIO,Gastric Cancer / Gastroesophageal junction adenocarcinoma,Phase 2a,2023-10-25 00:00:00,"Phase 2a data presented at ESMO showed that infigratinib was generally well tolerated with a manageable safety profile, noted October 25, 2023.",12,LABEL_12
+LIAN,Gastric Cancer / Gastroesophageal junction adenocarcinoma,Phase 2a,2023-10-25 00:00:00,"Phase 2a data presented at ESMO showed that infigratinib was generally well tolerated with a manageable safety profile, noted October 25, 2023.",12,LABEL_12
+BIIB,Alzheimer’s disease,Phase 3,2023-10-25 00:00:00,"Phase 3 presentation at CTAD reported a 14% greater amyloid plaque removal than biweekly IV administration as suggested in a preliminary analysis using amyloid PET at 6 months of treatment, noted October 25, 2023.",14,LABEL_14
+BIVI,Alzheimer’s disease,Phase 3,2023-10-25 00:00:00,"Phase 3 presented at CTAD showed statistically significant population changes from baseline were observed for all primary and secondary cognitive and functional assessments measured: ADAS-Cog12, ADCS-CGIC, MMSE, CDR, CDR-SB, ADCOMS, and ADL, noted October 25, 2023.",14,LABEL_14
+BMY,Ulcerative colitis (UC),Phase 2,2023-10-26 00:00:00,"Phase 2 trial was unsuccessful, noted October 26, 2023.",10,LABEL_10
+PFE,"Influenza and COVID-19, Omicron BA.4/BA.5-adapted bivalent",Phase 1/2,2023-10-26 00:00:00,"Phase 1/2 data demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains, noted October 26, 2023.",7,LABEL_7
+ORTX,Mucopolysaccharidosis type I (MPS-I),Phase 1,2023-10-26 00:00:00,"PoC data presented at ESGCT resulted in improvement 62.5% of patients or stabilization 37.5% of patients of corneal clouding at the time of last follow-up ranging from 3.14-4.58 years compared to baseline measured prior to administration with OTL-203, noted October 26, 2023.",6,LABEL_6
+BNTX,"Influenza and COVID-19, Omicron BA.4/BA.5-adapted bivalent",Phase 1/2,2023-10-26 00:00:00,"Phase 1/2 data demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains, noted October 26, 2023.",7,LABEL_7
+BCRX,"Paroxysmal nocturnal hemoglobinuria (PNH), Healthy Volunteers",Phase 1,2023-10-26 00:00:00,"Phase 1 PoC trial with PNHl initiated, noted October 26, 2023.",6,LABEL_6
+CPRX,Duchenne Muscular Dystrophy (DMD),Approved,2023-10-26 00:00:00,"Approved October 26, 2023.",0,LABEL_0
+EWTX,Duchenne Muscular Dystrophy (DMD),Phase 2,2023-10-26 00:00:00,"Phase 2 cohort in boys initiated, October 26, 2023.",10,LABEL_10
+ASND,Solid tumors,Phase 1/2,2023-10-26 00:00:00,"Phase 1/2 updated data presented at ESMO resulted in clinical responses demonstrated as monotherapy or in combination with checkpoint inhibitor, noted October 26, 2023.",7,LABEL_7
+EWTX,Duchenne Muscular Dystrophy (DMD),Approved,2023-10-26 00:00:00,"Approved October 26, 2023.",0,LABEL_0
+REGN,Genetic hearing loss,Phase 1/2,2023-10-26 00:00:00,"Phase 1/2 data reported that one patient experienced improvements in auditory responses through week 6 compared to baseline, noted October 26, 2023.",7,LABEL_7
+EWTX,dystrophinopathies including Duchenne Muscular Dystrophy in children and adolescent boys,Phase 2,2023-10-26 00:00:00,"Phase 2 initiated, noted October 26, 2023.",10,LABEL_10
+ABOS,Alzheimer’s disease (AD),Phase 1,2023-10-27 00:00:00,"Additional Phase 1 results shared at CTAD reported that statistically significant amyloid plaque reduction that was comparable to approved and in-review therapies at similar time points, was observed in higher dose cohorts, noted October 27, 2023",6,LABEL_6
+ALEC,Frontotemporal Dementia,Phase 3,2023-10-27 00:00:00,"Phase 3 target enrollment achieved, noted October 27, 2023.",14,LABEL_14
+CGTX,Early Alzheimer's disease,Phase 2,2023-10-27 00:00:00,"Phase 2 data points to a role for the sigma-2 (σ-2) receptor in regulating key ""housekeeping"" processes such as autophagy that are impaired in Alzheimer's and other neurodegenerative diseases, noted October 27, 2023.",10,LABEL_10
+RHHBY,Macular edema due to RVO,Approved,2023-10-27 00:00:00,"Approved October 27, 2023.",0,LABEL_0
+CHRS,Nasopharyngeal carcinoma (NPC),Approved,2023-10-27 00:00:00,"FDA Approval on October 27, 202",0,LABEL_0
+VYNE,Vitiligo,Phase 1b,2023-10-30 00:00:00,"Phase 1b clinical proof-of-concept achieved with statistically significant dose dependent reduction in F-VASI score from baseline for the VYN201 1.0% and 2.0% cohorts compared to the 0.5% cohort, noted October 30, 2023.",9,LABEL_9
+DCPH,Tenosynovial Giant Cell tumor,Phase 3,2023-10-30 00:00:00,"Phase 3 study met primary endpoint with objective response rate (ORR) at week 25 of 40% compared to 0% for placebo. The study also met all key secondary endpoints at Week 25 compared to placebo, noted October 30, 2023.",14,LABEL_14
+RVPH,Schizophrenia,Phase 3,2023-10-30 00:00:00,"Phase 3 trial met primary endpoint, noted October 30, 2023.",14,LABEL_14
+PHAT,H. pylori,Approved,2023-10-30 00:00:00,"Prior Approval Supplement (PAS) for the reformulation of vonoprazan tablets approved October 30, 2023.",0,LABEL_0
+FDMT,Fabry Disease,Phase 1/2,2023-10-30 00:00:00,"Phase 1/2 FDA meeting to lift clinical hold and continue trial developments, noted October 30, 2023.",7,LABEL_7
+CHRS,1L Metastatic Nasopharyngeal Carcinoma,Approved,2023-10-30 00:00:00,"Approved October 27, 2023.",0,LABEL_0
+SLS,"Hematologic malignancies, acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and lymphoma",Phase 2a,2023-10-30 00:00:00,"FDA granted fast track designation, noted October 30, 2023.",12,LABEL_12
+APTO,Acute myeloid leukemia (AML),Phase 1/2,2023-10-30 00:00:00,"Phase 1/2 data demonstrated 44% ORR with TUS/VEN in Difficult-to-Treat VEN Failure R/R AML Patients, noted October 30, 2023.",7,LABEL_7
+CVM,Head and Neck cancer,Phase 3,2023-10-30 00:00:00,"Phase 3 data finalized target population data resulted in risk of death cut in half at five years versus the control, 28.6% absolute 5-year overall survival benefit versus control, 0.349 hazard ratio vs control , noted October 30, 2023.",14,LABEL_14
+RHHBY,Duchenne muscular dystrophy,Phase 3,2023-10-30 00:00:00,"Phase 3 trial results showed that participants treated with ELEVIDYS (delandistrogene moxeparvovec-rokl) showed an increase on the North Star Ambulatory Assessment, a measure of motor function, compared to placebo-treated patients at 52 weeks, although the primary endpoint was not met, noted October 30, 2023.",14,LABEL_14
+SRPT,Duchenne muscular dystrophy,Phase 3,2023-10-30 00:00:00,"Phase 3 trial results showed that participants treated with ELEVIDYS (delandistrogene moxeparvovec-rokl) showed an increase on the North Star Ambulatory Assessment, a measure of motor function, compared to placebo-treated patients at 52 weeks, although the primary endpoint was not met, noted October 30, 2023.",14,LABEL_14
+LIAN,Demodex blepharitis,Phase 3,2023-10-30 00:00:00,"Phase 3 results demonstrated statistically significant mite eradication in patients treated compared to vehicle, noted October 30, 2023.",14,LABEL_14
+ANVS,Alzheimer’s disease (AD),Phase 2/3,2023-10-30 00:00:00,"Phase 2/3 trial DSMB feedback resulted in no drug-related SAEs, each AE < 5% and a very low dropout rate of 4.7%, noted October 30, 2023.",11,LABEL_11
+GOVX,COVID-19 in immunocompromised patients,Phase 2,2023-10-30 00:00:00,"Phase 2 site expansion commenced, noted Otober 30, 2023.",10,LABEL_10
+CNTA,Hemophilia B,Phase 2b,2023-10-31 00:00:00,"Phase 2b initiated, noted October 31, 2023.",13,LABEL_13
+GRTX,Pancreatic Cancer,Phase 2b,2023-10-31 00:00:00,"Phase 2b did not pass futility analysis, so trial halted to preserve cash, noted October 31, 2023.",13,LABEL_13
+GRTX,Non-Small Cell Lung Cancer (NSCLC),Phase 1/2,2023-10-31 00:00:00,"Phase 1/2 halted after GRECO-2 failed futility analysis, so trial halted to preserve cash, noted October 31, 2023.",7,LABEL_7
+CYBN,Major Depressive Disorder (MDD) and Alcohol use disorder (AUD),Phase 1/2,2023-10-31 00:00:00,"Phase 1/2a topline data reported that the reduction in major depressive disorder (""MDD"") symptoms, defined as change from baseline in MADRS total score, was superior in participants assigned to CYB003 compared to the participants who received placebo by 14.08 points, noted October 31, 2023.",7,LABEL_7
+REGN,Non-small cell lung cancer (NSCLC),Phase 2,2023-10-31 00:00:00,"Phase 2 preliminary efficacy data reported a 100% Disease Control Rate (DCR), noted October 31, 2023.",10,LABEL_10
+MAIA,Non-small cell lung cancer (NSCLC),Phase 2,2023-10-31 00:00:00,"Phase 2 preliminary efficacy data reported a 100% Disease Control Rate (DCR), noted October 31, 2023.",10,LABEL_10
+AMGN,Chronic spontaneous urticaria,Phase 2b,2023-10-31 00:00:00,"Phase 2b trial did not meet its primary endpoint, noted October 31, 2023.",13,LABEL_13
+INDP,Advanced/metastatic solid tumors,Phase 1,2023-10-31 00:00:00,"Phase 1 data abstract to be presented at SITC on November 4, 2023 noted that each of the first cohort participants experienced transient activation of biomarkers associated with innate and/or adaptive immune responses, and generally expected transient adverse events, noted October 31, 2024.",6,LABEL_6
+AMGN,Moderate to severe genital psoriasis,Phase 3,2023-10-31 00:00:00,"Phase 3 data presented that treated patients across subgroups experienced greater improvement in genital psoriasis and genital itch at week 16 compared to placebo, noted October 31, 2023.",14,LABEL_14
+EVAX,Metastatic Melanoma,Phase 2b,2023-10-31 00:00:00,"Phase 2b data presented at SITC reported that a pronounced and ongoing tumor reduction was observed in a patient with progressive disease, noted October 31, 2023.",13,LABEL_13
+NVS,Hidradenitis Suppurativa (HS),Approved,2023-10-31 00:00:00,"Approved October 31, 2023.",0,LABEL_0
+MRK,Metastatic Melanoma,Phase 2b,2023-10-31 00:00:00,"Phase 2b data presented at SITC reported that a pronounced and ongoing tumor reduction was observed in a patient with progressive disease, noted October 31, 2023.",13,LABEL_13
+KTRA,Glioblastoma (GBM),Phase 2/3,2023-10-31 00:00:00,"Phase 2/3 data reported that it did not perform better than the current standards of care in glioblastoma, noted October 31, 2023.",11,LABEL_11
+PFE,Glioblastoma (GBM),Phase 2/3,2023-10-31 00:00:00,"Phase 2/3 data reported that it did not perform better than the current standards of care in glioblastoma, noted October 31, 2023.",11,LABEL_11
+BHVN,Glioblastoma (GBM),Phase 2/3,2023-10-31 00:00:00,"Phase 2/3 data reported that it did not perform better than the current standards of care in glioblastoma, noted October 31, 2023.",11,LABEL_11
+KZIA,Glioblastoma (GBM),Phase 2/3,2023-10-31 00:00:00,"Phase 2/3 data reported that it did not perform better than the current standards of care in glioblastoma, noted October 31, 2023.",11,LABEL_11
+AMGN,Metastatic castrate-resistant prostate cancer (mCRPC),Phase 1b,2023-10-31 00:00:00,"Phase 1b initial data reported that efficacy was greater at higher doses (doses ≥0.75 mg target dose) where PSA50 was 59% (n=44) and RECIST objective response rate was 41% (n=37). The safety profile was clinically manageable, with CRS that was generally low grade and primarily in cycle 1, noted October 31, 2023.",9,LABEL_9
+MNPR,Soft tissue sarcoma,Phase 1b,2023-11-01 00:00:00,"t, as well, which may result in further tumor size reduction, noted August 8, 2023. Phase 1b data showed that 9 out of the 14 patients have had stable disease (SD, as defined by RECIST 1.1 criteria) after camsirubicin treatment., noted November 1, 2023.",9,LABEL_9
+MRK,Biliary Tract Cancer,Approved,2023-11-01 00:00:00,"Approved November 1, 2023.",0,LABEL_0
+MRK,Renal cell carcinoma (RCC),Phase 3,2023-11-01 00:00:00,"Phase 3 trial met its primary endpoint, noted November 1, 2023.",14,LABEL_14
+TNXP,Major depressive disorder (MDD),Phase 2,2023-11-01 00:00:00,"Phase 2 topline data reported that the trial did not meet its primary endpoint, noted November 1, 2023.",10,LABEL_10
+DARE,Female Sexual Arousal Disorder (FSAD),Phase 2b,2023-11-01 00:00:00,"Phase 2b exploratory data reported that trial achieved statistical significance and clinically meaningful improvement in Phase 2b co-primary endpoint assessing arousal sensation, and statistical significance in items from Phase 2b co-primary endpoint scale evaluating concern related to difficulties with sexual arousal in subset analyses, noted November 1, 2023.",13,LABEL_13
+SLN,Cardiovascular diseases,Phase 1,2023-11-01 00:00:00,"Phase 1 data showed very significant and durable reductions in lipoprotein(a) of up to 99%. Lp(a) levels remained around 90% lower than baseline at study endpoint, noted November 1, 2023.",6,LABEL_6
+CLSD,Neovascular age-related macular degeneration (wet AMD),Phase 2b,2023-11-01 00:00:00,"Phase 2b recruitment completed, noted November 1, 2023.",13,LABEL_13
+FDMT,Cystic fibrosis,Phase 2,2023-11-01 00:00:00,"Phase 2 Dose Expansion interim data presented at the North American Cystic Fibrosis Conference showed that it was generally well tolerated with no inflammation in any lung biopsy across Cohorts 1 and 2 (1E15 & 2E15 vg; n=7) with up to 17 months follow-up November 1, 2023.",10,LABEL_10
+PHAT,Erosive esophagitis / Gastroesophageal reflux disease (GERD),Approved,2023-11-01 00:00:00,"FDA Approved on November 1, 2023.",0,LABEL_0
+RANI,Neuroendocrine tumors (NETs) and acromegaly,Phase 1,2023-11-01 00:00:00,"Program discontinued, noted November 1, 2023.",6,LABEL_6
+RANI,Rheumatoid arthritis,Phase 1,2023-11-01 00:00:00,"Program paused, noted November 1, 2023.",6,LABEL_6
+INVA,Uncomplicated gonorrhea,Phase 3,2023-11-01 00:00:00,"Phase 3 data met the primary endpoint when compared against the combination of injectable ceftriaxone and oral azithromycin, noted November 1, 2023.",14,LABEL_14
+CCCC,Synovial sarcoma,Phase 1,2023-11-01 00:00:00,"Phase 1 deprioritized due to insufficient single agent efficacy, despite high levels of BRD9 degradation, noted November 1, 2023.",6,LABEL_6
+KROS,Myelodysplastic syndromes (MDS),Phase 2,2023-11-02 00:00:00,"Phase 2 data from ASH abstract reported that the median treatment duration was 166 days (range 6 to 649). Most participants (89.8%) had at least 1 treatment-emergent adverse event (TEAE), and 32.2% had TEAEs considered treatment-related, noted November 2, 2023.",10,LABEL_10
+JSPR,Acute myeloid leukemia/Myelodysplastic syndrome (AML/MDS),Phase 1,2023-11-02 00:00:00,"Phase 1 results from abstracts reported that 10 of 13 AML in CR and 14 of 16 MDS subjects had MRD at pre-HCT screening assessed by cytogenetics, flow cytometry, and/or next generation sequencing, noted November 2, 2023.",6,LABEL_6
+IRON,Myelofibrosis (MF) patients with anemia,Phase 1/2,2023-11-02 00:00:00,"Phase 1b/2 data from abstracts reported dose-dependent reductions in serum hepcidin-25 and increases in serum iron levels, noted November 2, 2023.",7,LABEL_7
+IRON,Erythropoietic Protoporphyria (EPP),Phase 2,2023-11-02 00:00:00,"Phase 2 data from abstract reported that treatment with bitopertin resulted in mean (SD) decreases in PPIX of -39% by Day 43, noted November 2, 2023.",10,LABEL_10
+IPSC,Lymphoma or Indolent Lymphoma,Phase 1,2023-11-02 00:00:00,"Phase 1 data from ASH abstract reported that one patient achieved a complete response that is ongoing as of five months following their first CNTY-101 infusion, noted November 2, 2023.",6,LABEL_6
+INAB,Allogeneic hematopoietic stem cell transplantation (HSCT),Phase 1,2023-11-02 00:00:00,"Phase 1 data from ASH abstract reported that treatment emergent AE's included transient WBC and ANC decreased (100% each), platelet count decreased and anemia (88.9% each) and maculopapular rash, hypomagnesemia and blood creatine increased (55.6% each), noted November 2, 2023.",6,LABEL_6
+HARP,Multiple myeloma,Phase 1,2023-11-02 00:00:00,"Phase 1 data from ASH abstract reported that among the 12mg and 24mg cohorts, 55% (22/40) of efficacy-evaluable pts currently have had a confirmed response (PR or better) and among pts with a response, 73% (16/22) have had a confirmed response of VGPR or better, noted November 2, 2023.",6,LABEL_6
+NTLA,Transthyretin amyloidosis (ATTR),Phase 1,2023-11-02 00:00:00,"Phase 1 updated data from over 60 patients showed consistent, deep and durable serum TTR reduction achieved with a single dose of NTLA-2001, including in 29 patients who have now reached 12 months or more of follow-up, noted November 2, 2023.",6,LABEL_6
+OTLK,Wet age-related macular degeneration (wet AMD),BLA Filing,2023-11-02 00:00:00,"The FDA informed the company that an additional adequate and well-controlled clinical trial would be required for the approval of ONS-5010 for wet AMD. Resubmission of the ONS-5010 BLA as early year end 2024, noted November 2, 2023.",1,LABEL_1
+REGN,Transthyretin amyloidosis (ATTR),Phase 1,2023-11-02 00:00:00,"Phase 1 updated data from over 60 patients showed consistent, deep and durable serum TTR reduction achieved with a single dose of NTLA-2001, including in 29 patients who have now reached 12 months or more of follow-up, noted November 2, 2023.",6,LABEL_6
+ACXP,C. difficile Infection,Phase 2b,2023-11-02 00:00:00,"Phase 2a and 2b data reported an observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96%, noted November 2, 2023.",13,LABEL_13
+MEIP,B-Cell Malignancies or Acute Myeloid Leukemia (AML),Phase 1,2023-11-02 00:00:00,"Phase 1 data from ASH abstract reported that at 200 mg, 5 of 10 AML pts (50%) had stable disease, noted November 2, 2023.",6,LABEL_6
+MOLN,Acute myeloid leukemia (AML),Phase 1,2023-11-02 00:00:00,"Phase 1 data from ASH abstract reported that one of the two patients evaluable for MP0533 antitumor activity in the third treatment cohort achieved a response, noted November 2, 2023.",6,LABEL_6
+EYEN,Mydriasis (office-based pupil dilation),Approved,2023-11-02 00:00:00,"FDA supplemental approval on November 1, 2023.",0,LABEL_0
+ALPN,"Lupus nephritis, IgA nephropathy",Phase 1/2,2023-11-02 00:00:00,"Phase 1b/2a data presented at ASN reported that treatment reduced UPCR by greater than 50% in IgA nephropathy, noted November 2, 2023.",7,LABEL_7
+NRIX,B-cell malignancies / graft-versus-host disease,Phase 1a,2023-11-02 00:00:00,"Phase 1a data from ASH abstract reported that of three evaluable patients with CLL receiving the lowest dose of 50 mg, early signs of clinical activity were observed including one confirmed partial response and 2 patients with stable disease, noted November 2, 2023.",8,LABEL_8
+MTEM,Solid tumors,Phase 1,2023-11-02 00:00:00,"Phase 1 dosing initiated, noted November 2, 2023.",6,LABEL_6
+OMER,Paroxysmal nocturnal hemoglobinuria (PNH),Phase 1b,2023-11-02 00:00:00,"Phase 1b data from ASH abstract reported that mean Hgb increased from baseline by 3.1 g/dL at 4 weeks, and by 9.5 g/dL at the latest timepoint of 24 weeks, noted November 2, 2023.",9,LABEL_9
+NRIX,"B-cell malignancies, chronic lymphocytic leukemia (CLL)",Phase 1b,2023-11-02 00:00:00,"Phase 1b data from ASH abstract reported that 9 PRs/PR with rebound lymphocytosis; additionally, 11 patients had SD at the time of data cut-off and 4 had PD, noted November 2, 2023.",9,LABEL_9
+SONN,Healthy volunteers,Phase 1,2023-11-02 00:00:00,"Phase 1 interim analysis presented at CTAD reported that in single doses up to 300 ng/kg and in patients with advanced cancer in repeated doses up to at least 540 ng/kg. Incorporation of a desensitizing first dose at 150-300 ng/kg and dosing every 3 weeks has been implemented to capitalize on the potential benefits of tachyphylaxis with rhIL-12, noted November 2, 2023.",6,LABEL_6
+FHTX,Synovial sarcoma,Phase 1,2023-11-02 00:00:00,"Phase 1 preliminary results shared at the Connective Tissue Oncology Society Annual Meeting reported that FHD-609 treatment led to dose-dependent BRD9 degradation in tumor tissue, noted November 2, 2023.",6,LABEL_6
+KRON,Solid tumors,Phase 1/2,2023-11-02 00:00:00,"Phase 2 initial data presented at Connective Tissue Oncology Society reported that treatment demonstrated on-mechanism, single agent anti-tumor activity and a manageable safety profile in heavily pre-treated patients with transcriptionally addicted solid tumors, noted November 2, 2023.",7,LABEL_7
+OPK,Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) - Stage 5,Phase 2,2023-11-02 00:00:00,"Phase 2 data presented at ASH indicated that early, sustained and effective treatment of secondary hyperparathyroidism (SHPT) with RAYALDEE is associated with significantly slower progression CKD in pre-dialysis patients, noted November 2, 2023.",10,LABEL_10
+MLYS,Hypertension,Phase 2,2023-11-02 00:00:00,"Phase 2 data to be presented ASN further supports obesity-associated dysregulated aldosterone as an endotype predictive of enhanced response, noted November 2, 2023.",10,LABEL_10
+TCRX,Hematologic malignancies,Phase 1,2023-11-02 00:00:00,"Phase 1 data from abstract reported that the safety analysis found expected post-HCT adverse events similar in treatment and control arms. Incidence of graft-versus-host disease (GvHD) was similar in control (3 events) and treatment arms, noted November 2, 2023.",6,LABEL_6
+LLY,Atopic Dermatitis,CRL,2023-11-02 00:00:00,"CRL received in the US, noted November 2, 2023.",2,LABEL_2
+ELDN,Kidney transplant rejection,Phase 2,2023-11-02 00:00:00,"Phase 2 data from 11 participants demonstrates tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated, noted November 2, 2023.",10,LABEL_10
+SDGR,B-cell lymphoma,Phase 1,2023-11-02 00:00:00,"Phase 1 data from ASH abstract reported that treatment showed excellent potency in the biochemical assay and strong anti-proliferative effects on ABC-DLBCL cells, noted November 2, 2023.",6,LABEL_6
+PFE,Hemophilia A or B,Phase 3,2023-11-02 00:00:00,"Phase 3 data from ASH abstract reported that OD group reported 12 (36.4%) adverse events (AEs) during ATP vs 9 (24.3%) in OP whereas the RP group reported 62 (74.7%) AEs in ATP vs 20 (22.0%) in OP, noted November 2, 2023.",14,LABEL_14
+GBT,Sickle cell disease (SCD),Phase 2/3,2023-11-02 00:00:00,"Phase 2/3 data from ASH abstract reported that safety data showed GBT021601 was well tolerated. For 27 patients with VOC at baseline, the baseline annualized VOC rate was 2.30, noted November 2, 2023.",11,LABEL_11
+PFE,Sickle cell disease (SCD),Phase 2/3,2023-11-02 00:00:00,"Phase 2/3 data from ASH abstract reported that safety data showed GBT021601 was well tolerated. For 27 patients with VOC at baseline, the baseline annualized VOC rate was 2.30, noted November 2, 2023.",11,LABEL_11
+PTGX,Polycythemia vera,Phase 2,2023-11-02 00:00:00,"Phase 2 data from abstract reported that treatment resulted in consistent maintenance of hematocrit below 45% and an overall decrease in erythrocyte counts, noted November 2, 2023.",10,LABEL_10
+STTK,Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS),Phase 1,2023-11-02 00:00:00,"Phase 1 data from ASH abstract reported that in 4 evaluable pts with UnTx TP53m-MDS, the ORs were 1 complete remission (CR), 1 marrow CR, and 2 stable disease. 2 of them proceeded to allo-HCT, noted November 2, 2023.",6,LABEL_6
+ORIC,Multiple myeloma,Phase 1b,2023-11-02 00:00:00,"Phase 1b data from ASH abstract reported that ORIC-533 was very well tolerated, with 5 patients experiencing a total of 10 treatment-related adverse events (TRAEs), noted November 2, 2023.",9,LABEL_9
+MOLN,Solid Tumors,Phase 1,2023-11-03 00:00:00,"Phase 1 data presented at SITC continues to demonstrate tumor-localized CD40 activation, leading to elevated immune activity in the tumor microenvironment, noted November 3, 202",6,LABEL_6
+AZN,Chronic Kidney Disease (CKD),Phase 2b,2023-11-03 00:00:00,"Phase 2b showed statistically significant and clinically meaningful reductions in urinary albumin-to-creatinine ratio (UACR), noted November 3, 2023.",13,LABEL_13
+TVTX,Focal segmental glomerulosclerosis (FSGS),Phase 3,2023-11-03 00:00:00,"Phase 3 presentations at ASN showed that sparsentan delivered a clinically meaningful benefit at 108 weeks with significant proteinuria reduction, higher rates of partial and complete remission, and lower rates of end-stage kidney disease, noted November 3, 2023.",14,LABEL_14
+TVTX,IgA nephropathy (IgAN),Phase 3,2023-11-03 00:00:00,"Additional Phase 3 data presented at ASN showed one of the slowest rates of kidney function decline in IgAN trials, consistent treatment effects across baseline eGFR and proteinuria, and higher rates of complete remission compared to maximally tolerated dose of irbesartan through 110 weeks of treatment, noted November 3, 2023.",14,LABEL_14
+IPHA,Mycosis Fungoides,Phase 2,2023-11-03 00:00:00,"Phase 2 data from ASH abstract reported that the global confirmed ORR was 37.5% including 2 CRs, with a median time to response of 2.8 months, noted November 3, 2023.",10,LABEL_10
+HOWL,Solid Tumors,Phase 1b,2023-11-03 00:00:00,"Phase 1/1b preliminary data provided compelling early evidence of dose-dependent biomarker and antitumor activity in patients, including two patients with ongoing unconfirmed partial responses (uPR) in the highest dose tested to date, cohort 4 (12 mg), noted November 3, 2023.",9,LABEL_9
+AUPH,Lupus Nephritis,Phase 3,2023-11-03 00:00:00,"Phase 3 data from ASN reported that treated patients in the overall AURORA 2 cohort maintained stable renal function over the last two years of the study, as measured by eGFR analysis and experienced numerically greater mean reductions in urine protein creatinine ratio (UPCR), compared to patients in the control arm, noted November 3, 2023.",14,LABEL_14
+CADL,Pancreatic Cancer,Phase 2,2023-11-03 00:00:00,"Phase 2 initial overall survival and immunological biomarker data presented at SITC revealed notable improvements in patients with borderline resectable pancreatic ductal adenorcarcinoma (PDAC) after experimental treatment with CAN-2409, noted November 3, 2023.",10,LABEL_10
+PSTV,Leptomeningeal metastases (LM),Phase 1/2,2023-11-03 00:00:00,"FDA granted Orphan Drug Designation (ODD), noted November 3, 2023.",7,LABEL_7
+CUE,HPV16+ head and neck cancer,Phase 1,2023-11-03 00:00:00,"Phase 1 data shared at SITC showed an overall response rate (ORR) of 47% and disease control rate (DCR) of 65% in first line (1L) HNSCC patients treated with CUE-101 and pembrolizumab. ORR of 56% in patients with low expression of PD-L1 in the tumor, noted November 3, 2023.",6,LABEL_6
+INKT,Solid Tumors,Phase 1,2023-11-03 00:00:00,"Phase 1 trial of agenT-797 alone or in combination showed durable clinical benefit, including: Clinical response in MSI-high 3L gastric cancer patient after failure on pembrolizumab and nivolumab/FOLFOX. Long-term disease stabilization (n=10), including in testicular cancer (SD 9 months) and anti-PD-1 relapsed/refractory non-small-cell lung cancer (SD > 10 months). Tolerable safety profile with no dose-limiting toxicities and no grade >3 neurotoxicity or cytokine release syndrome, noted November 3, 2023.",6,LABEL_6
+RAPT,Advanced Cancer,Phase 1/2,2023-11-03 00:00:00,"Phase 1/2 update SITC showed a confirmed objective response rate (ORR) of 40% in PD-L1 positive (TPS ≥1%) patients with no prior checkpoint inhibitor therapy (CPI). Median progression-free survival (PFS) of 6.3 months in PD-L1 positive patients at time of data cut off, noted November 3, 2023",7,LABEL_7
+XAIR,Solid tumors,Phase 1,2023-11-03 00:00:00,"Phase 1 data presented at SITC demonstrated early clinical proof of concept, noted November 3, 2023.",6,LABEL_6
+XLO,Solid Tumors,Phase 1/2,2023-11-03 00:00:00,"Phase 1/2 trial data presented at SITC showed initial evidence of dose-dependent disease control rate with 50% disease control rate at higher doses (≥2.8 mg/kg) and 31% disease control rate across all dose levels in a range of solid tumor types, including cold tumors, noted November 3, 2023.",7,LABEL_7
+CGEM,Solid tumors,Phase 1,2023-11-03 00:00:00,"Phase 1 Initial clinical biomarker data demonstrated that CLN-619 increases MICA expression on the tumor cell surface, consistent with previously reported preclinical data and supporting the proposed mechanism of action, noted November 3, 2023.",6,LABEL_6
+HOOK,HPV16+ Squamous cell head and neck cancers (HNSCC),Phase 1,2023-11-03 00:00:00,"Phase 1 biomarker results demonstrated a robust increase in tumor-specific CD8+ T cells in all evaluable patients with HPV16+ head and neck cancers, noted November 3, 2023. Randomized trial planned for 2024.",6,LABEL_6
+IMMP,Non-small cell lung cancer; Head and neck cancer,Phase 2,2023-11-03 00:00:00,"Additional biomarker results shared at SITC showed statistically significant increases of Th1 biomarkers (IFN-gamma, CXCL-10), circulating immune cells (lymphocytes), and RNA levels of immune activating genes were observed and linked to improved clinical outcomes, noted November 3, 2023.",10,LABEL_10
+SRRK,Solid Tumors,Phase 1,2023-11-03 00:00:00,"Phase 1 biomarker data presented at SITC showed promising anti-tumor activity in heavily pretreated clear cell renal cell carcinoma (ccRCC) patients. Objective response rate (ORR) of 21.4% and disease control rate of 57%, noted November 3, 2023.",6,LABEL_6
+KA,Solid tumors,Phase 1/2,2023-11-03 00:00:00,"Phase 1/2 biomarker data to be presented at SITC, noted Noember 3 2023.",7,LABEL_7
+FLGT,Various cancers,Phase 1/2,2023-11-03 00:00:00,"Phase 1/2 data reported that FID-007 may have anti-tumor activity in heavily pre-treated patients across various tumor types, and a subgroup analysis based on 7 patients for Head and Neck cancer and 4 patients for Ampullary/Pancreatic cancer showed 57% and 50% objective response rate, respectively, noted November 3, 2023.",7,LABEL_7
+ELTX,Solid Tumors,Phase 1/2,2023-11-03 00:00:00,"Phase 1/2 data presented at SITC reported that 87% (20/23) had direct ex vivo mKRAS-specific T cell responses, and 100% (23/23) had in vitro stimulated responses, noted November 3, 2023.",7,LABEL_7
+CUE,Wilms' Tumor (WT1)-expressing cancers,Phase 1,2023-11-03 00:00:00,"Phase 1 data presented at SITC demonstrated a 75%-80% DCR at the 4mg/kg and 2mg/kg doses respectively with two patients demonstrating tumor reductions of -30% and -29%, noted November 3, 2023.",6,LABEL_6
+REGN,Various cancers,Phase 1,2023-11-04 00:00:00,"Phase 1 safety data reported that a total of 11 adverse events (including one serious adverse event not considered related to SNS-101) was reported in five patients, with no dose-limiting toxicities observed, noted November 4, 2023.",6,LABEL_6
+SNSE,Various cancers,Phase 1,2023-11-04 00:00:00,"Phase 1 safety data reported that a total of 11 adverse events (including one serious adverse event not considered related to SNS-101) was reported in five patients, with no dose-limiting toxicities observed, noted November 4, 2023.",6,LABEL_6