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BioPharma

Dataset card Data Studio Files
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DAWN
Low-grade Glioma
Phase 2
6/5/23
Additional Phase 2 presented at ASCO reported an ORR of 67% and clinical benefit rate (CBR) of 93% in 69 heavily pretreated RANO-HGG evaluable patients, noted June 5, 2023.
6
ATAI
Opioid Use Disorder
Phase 1
12/23/22
Additional results from part 2 showed that a single dose was generally well tolerated and was observed to produce analgesic effects on CPT comparable to those seen in Part 1 of this trial, noted December 23, 2022.
6
ABBV
Augmentation of the chin region
Approved
6/15/20
FDA Approval announced June 15, 2020.
6
FGEN
Idiopathic pulmonary fibrosis (IPF)
Phase 3
6/26/23
Phase 3 after ZEPHYRUS-1 results, company decided to discontinue this study, noted June 26, 2023.
4
ENTA
Respiratory Syncytial Virus RSV-A and RSV-B
Phase 1
6/20/23
Phase 1 data demonstrated favorable safety, tolerability, and PK supportive of once-daily dosing, with good exposure multiples, thereby supporting further clinical advancement of EDP-323, noted June 20, 2023.
6
MRK
Ulcerative colitis
Phase 2
3/1/23
Phase 2 trial met all ranked secondary endpoints, noted March 1, 2023.
5
NVS
Psoriatic arthritis
Phase 3
11/1/19
Phase 3 data did not meet primary endpoint - October 31, 2019.
4
SGEN
Urothelial cancer
Approved
4/3/23
FDA Approved on April 3, 2023.
6
PFE
Postherpetic neuralgia (PHN)
Approved
10/12/17
Approval announced October 12, 2017.
6
RHHBY
Influenza
Approved
10/18/19
FDA Approval announced October 18, 2019.
6
XAIR
Solid tumors
Phase 1
11/3/23
Phase 1 data presented at SITC demonstrated early clinical proof of concept, noted November 3, 2023.
6
AZN
Non-small Cell Lung Carcinoma
Approved
12/21/20
FDA approval announced December 21, 2020.
6
FBIO
B-cell Non-Hodgkin Lymphoma & Chronic Lymphocytic Leukemia (CLL)
Phase 1/2
8/16/23
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.
6
AZN
Metastatic Breast Cancer
Phase 1/2
12/9/22
Phase 1/2 presentation reported that treatment significantly reduced risk of death by 36%, noted December 9, 2022.
6
BGNE
Hepatocellular carcinoma (HCC)
Phase 3
6/5/23
Phase 3 additional data presented at ASCO reported that treatment demonstrated numerically longer median overall survival (OS) versus sorafenib in the biomarker subgroups of ALBI grade 1 (19.9 months vs. 16.9 months), PLR ≤141 (19.4 months vs. 14.5 months), and NLR ≤3 (20.9 months vs. 15.2 months, noted June 5, 2023.
6
PFE
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Approved
2/12/21
FDA approval announced February 12, 2021.
6
SIOX
Parkinson's disease
Phase 1/2
10/6/20
Two evaluable patients in Cohort 2 demonstrated a 21-point mean improvement in the UPDRS Part III “OFF” score, representing a 40% improvement from the baseline average score of 52 in these patients. Two other patients not evaluated.
6
HLVX
GI.1/GII.4 virus-like particle (VLP) vaccine
Phase 2
7/20/22
Phase 2 data reported that Pan-Ig and HBGA blocking antibody responses persisted to year 5 and no adverse events reported were determined to be related to treatment, noted July 20, 2022.
6
BMY
Mesothelioma
Approved
10/2/20
FDA approval announced October 2, 2020.
6
MRK
COVID-19
Phase 3
2/21/23
Phase 3 trial did not meet statistical significance, noted February 21, 2023.
6
ARCT
COVID-19 vaccine
Phase 1/2
12/28/20
Phase 1/2 data released December 28, 2020.
5
BIIB
Biosimilar (ranibizumab)
Approved
9/20/21
Approved September 20, 2021.
6
CHRS
NSCLC neoadjuvant setting
Phase 3
6/3/23
Phase 3 Interim event-free survival (EFS) analysis presented at ASCO reported that MPR and pCR rates per BIPR were higher in the toripalimab arm, 48.5% vs 8.4% and 24.8% vs 1.0%, respectively, noted June 3, 2023.
6
CHRS
Non-small cell lung cancer (NSCLC)
Phase 3
6/6/23
Phase 3 final overall survival and biomarker analyses presented at ASCO reported a significant improvement in OS was observed for the toripalimab arm over the placebo arm: median OS 23.8 vs 17.0 months, noted June 6, 2023.
6
PIRS
Asthma
Phase 2a
6/21/23
Phase 2a AstraZeneca communicated to Pieris its decision to discontinue and cease dosing in the ongoing clinical studies, the decision was based on lung findings from a non-clinical 13-week GLP toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development, noted June 21, 2023.
4
CALT
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Phase 2
7/13/23
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.
6
NXTC
PD-1 axis inhibitor refractory non-small cell lung cancer (NSCLC)
Phase 2
9/12/23
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.
5
ZLDPF
Obesity
Phase 1b
6/24/23
Phase 1b trial data showed that after one week of treatment, mean body weight reductions reached 2.6%, 3.6% and 4.2% from baseline following a single dose of 0.7 mg, 1.4 mg or 2.4 mg ZP8396, respectively. Reductions in body weight were dose-dependent, consistent and well-sustained during the additional five weeks of observation without further doses of ZP8396. Placebo-treated participants demonstrated a mean body weight increase of 0.6% after one week that continued to increase in most participants during the follow-up period, noted June 24, 2023.
6
VCNX
Non-small cell lung cancer (NSCLC)
Phase 1/2
4/27/20
Phase 1/2 updated data presented April 27, 2020 at AACR noted 81% of immunotherapy-naïve patients (17/21) experienced disease control - partial response (5/21 patients) or stable disease (12/21 patients)
6
SUPN
Migraine
Approved
4/5/17
Tentative approval August 19 2016, subject to the pediatric exclusivity which expires March 28, 2017. Final approval announced April 6, 2017.
6
NVS
Hidradenitis Suppurativa (HS)
Approved
10/31/23
Approved October 31, 2023.
6
AZN
Ovarian cancer
Phase 3
3/12/20
Phase 3 trial did not meet primary endpoint.
4
INBX
Chondrosarcoma and mesothelioma
Phase 1
4/26/23
Clinical hold lifted, noted April 26, 2023. Phase 1 combination cohorts are expected to begin reading out by year end 2023 and data from the registration-enabling trial in unresectable or metastatic conventional chondrosarcoma is expected during the 2H 2024.
5
AGIO
IDH1 mutant cholangiocarcinoma - cancer
Phase 3
9/30/19
Data presented at ESMO 2019 PFS HR HR=0.37.
5
PCVX
Invasive Pneumococcal Disease (IPD)
Phase 1/2
10/19/23
IND cleared by FDA, noted October 19, 2023
5
PRTC
Solid tumors
Phase 1/2
12/12/22
Phase 1/2 data reported no dose limiting toxicities, noted December 12, 2022.
5
NKTR
Gram-Negative Pneumonia (INHALE 1)
Phase 3
11/24/17
Phase 3 data released November 24, 2017. Endpoints not met.
4
OTIC
Ear Tube Placement Surgery
Approved
12/11/15
Approved December 11, 2015.
6
REGN
Multiple myeloma
Phase 2
12/12/22
Phase 2 data reported a 64% response rate, with 45% of responders achieving a very good partial response or better, noted December 12, 2022.
6
AGIO
IDH1m Relapsed/Refractory AML - cancer
Approved
7/20/18
FDA Approval announced July 20, 2018.
6
RCUS
Metastatic castrate-resistant prostate cancer (mCRPC)
Phase 1/2
8/7/23
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.
6
TAK
Renal Cell Carcinoma (RCC)
Phase 3
9/8/22
Phase 3 data presented at ESMO reported that the median PFS was not reached for the triple combination and was 11.3 months for the combination of nivolumab and ipilimumab. Objective response rates in the PFS intent-to-treat population was 43% and 36%, respectively, noted September 8, 2022.
6
PFE
Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Approved
6/20/23
FDA Approved on June 20, 2023
6
ANIX
Ovarian Cancer
Phase 1
10/13/23
Phase 1 completed treatment of the first patient cohort, noted October 13, 2023.
6
GSK
Malaria
Approved
7/23/18
FDA Approval announced July 23, 2018.
6
VBIV
COVID-19 vaccine
Phase 1/2
6/29/21
Phase 1/2 initial data released June 29, 2021 - well-tolerated with no safety signals observed and induced neutralization titers in 100% of participants.
6
EBS
Anthrax Vaccine
Approved
7/21/23
Approved July 21, 2023.
6
NVS
Metastatic castration-resistant prostate cancer (mCRPC)
Approved
3/23/22
Approved March 23, 2022.
6
PRVB
Ulcerative Colitis
Phase 1b
5/8/19
Phase 1b top-line data May 8, 2019 noted primary safety and tolerability endpoint met but secondary efficacy endpoints were not met.
5
PFE
COVID-19 vaccine
Approved
6/17/22
EUA approval for children 4 years - 6 months, noted June 17, 2022.
6
ARQT
Chronic Hand Eczema
Phase 2
5/4/21
Phase 1/2b trial did not meet primary endpoint.
4
GILD
COVID-19 Coronavirus
Approved
1/21/22
Approval extended to non-hospitalized and pediatric patients January 21, 2022.
6
OGEN
Oral mucositis (OM)
Phase 2
4/15/20
Phase 2 data released April 15, 2020 did not meet primary endpoint.
4
VALN
Chikungunya Vaccine for adolecents
Phase 3
8/28/23
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.
6
BIIB
Alzheimer’s disease
Phase 3
10/25/23
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.
6
ENSC
Nasal Opioid Abuse
Phase 1
10/31/22
HAP data reported that PF614 powder produced significantly lower peak "drug liking" when compared with intranasal crushed IR oxycodone, noted October 31, 2022.
5
TPTX
Solid tumors
Phase 1
10/7/21
Phase 1 updated data noted a confirmed responses for a cORR of 36% out of the 11 MET TKI-naïve NSCLC patients, cORR of 33% for the nine MET TKI-naïve GC/GEJ patients, and among the 12 patients with advanced other solid tumors, one patient with MET amplified colorectal cancer achieved a confirmed response, noted October 7, 2021.
6
MNKD
Type 1/2 diabetes
Approved
6/27/14
Approved June 27, 2014.
6
BLU
Chronic cough
Phase 1
4/5/23
Phase 1 bioavailability equivalence data reported that treatment was well tolerated and demonstrated equivalent bioavailability to twice-daily Immediate Release formulation, noted April 5, 2023.
6
ABEO
Recessive dystrophic epidermolysis bullosa (RDEB)
BLA Filing
7/28/23
BLA filing package completed, noted July 28, 2023. FDA pre-BLA meeting in August 2023, and expected BLA submission on 3Q, 2023.
6
CFRX
Serious infections caused by Staph aureus including MRSA
Phase 3
7/13/22
Phase 3 DSMB interim futility recommended the trial be stopped, noted July 13, 2022.
4
ICVX
Respiratory syncytial virus (RSV) vaccine
Phase 1b
8/8/23
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.
5
RARE
Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD)
Approved
6/30/20
FDA Approval announced June 30, 2020.
6
LLY
HR+ / HER2- breast cancer
Approved
10/13/21
Approved October 13, 2021.
6
BCRX
Reduce or eliminate attacks in HAE patients
Approved
12/3/20
FDA approval announced December 3, 2020
6
OVID
Dravet Syndrome / Lennox-Gastaut Syndrome
Phase 3
4/27/23
Phase 3 data reported that 78% of patients tolerated the highest dose level well with sustained reduction in frequency of drop seizures, noted April 27, 2023.
6
LYRA
Chronic rhinosinusitis / Chronic Sinusitis
Phase 2
9/10/22
Additional Phase 2 results data presented at ARS demonstrated that significantly more patients at baseline improved to mild/no symptoms at week 24 after treatment compared to control, noted September 10, 2022.
6
BLPH
Pulmonary hypertension associated with Fibrotic Interstitial Lung Disease
Phase 3
6/5/23
Phase 3 enrollment completed, noted January 18, 2023. Phase 3 study did not meet the primary endpoint with iNO45 performing worse than placebo by 5.49 minutes per day, noted June 5, 2023.
6
ONCT
Chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL)
Phase 1/2
12/12/22
Phase 1/2 data reported that the ORR of 89% and CR rate of 43% for patients with MCL treated with zilovertamab plus ibrutinib compare favorably to the historical ORR of 66% and CR rate of 20% for ibrutinib monotherapy, noted December 12, 2022,
6
MRK
Metastatic Castration-Resistant Prostate Cancer
Phase 3
3/15/22
Phase 3 trial stopped following the recommendation of an independent Data Monitoring Committee (DMC), noted March 15, 2022.
4
RHHBY
Urothelial carcinoma
Phase 3
8/5/19
Phase 3 PFS co-primary endpoint met - August 5, 2019.
6
KPTI
Myelodysplastic syndrome (MDS), hypomethylating agents (HMA) refractory
Phase 2
5/3/23
Phase 2 data reported that treatment demonstrated a 27% overall response rate (ORR) in the intent-to-treat (ITT) population and a 31% ORR in the efficacy evaluable population, noted May 3, 2023.
6
KDNY
Primary Hyperoxaluria, Healthy Volunteers
Phase 1
6/17/23
Phase 1 healthy volunteer data at ERA 2023 showed that dosing was generally well tolerated in HVs who received single doses up to 500 mg and multiple doses (14 days) up to 60 mg, noted June 17, 2023
6
LLY
Pancreatic ductal adenocarcinoma (PDAC)
Phase 3
10/16/19
Phase 3 top-line data did not meet primary endpoint - October 16, 2019.
4
MNKKQ
Jaundice
CRL
8/22/18
CRL issued August 22, 2018.
5
BNTC
Oculopharyngeal muscular dystrophy (OPMD)
Phase 1/2
6/26/23
Phase 1b/2a IND clearance on June 26, 2023.
5
PFE
Pneumonia and influenza for >65 yrs
Phase 3
9/29/21
Phase 3 top-line results showed responses to the combination were noninferior to those elicited by the vaccines when administered one month apart. The safety profile of the combination was similar as compared to when each vaccine was administered separately, noted September 29, 2021.
5
IRON
Dry Age-related Macular Degeneration / Geographic Atrophy
Phase 2a
11/12/21
Additional data released November 12, 2021. Through 510 intravitreal administrations of GEM 103, no ocular serious adverse events related to study drug reported, no ocular adverse events leading to study discontinuation, and no anti-GEM103 antibodies detected in plasma. 17 patients (27.4%) experienced mild to moderate ocular adverse events in the study eye including two intraocular inflammation adverse events. Inflammation was mild or moderate and the patients recovered without recurrence and no study drug interruption. The moderate case was unrelated to GEM103 and the patient had a history of autoimmune disease. No increased risk observed for Choroidal Neovascularization (CNV). Two adverse events of neovascular AMD in the study eye occurred; in both cases, there were no definitive evidence of CNV by independent reading center's analysis of the retinal imaging. These events were determined to be unrelated to GEM103 and there was no impact on vision.
6
LNTH
Left Ventricular Ejection Fraction
Phase 3
2/3/20
Phase 3 trial did not meet primary endpoint - February 3, 2020.
4
GSK
Severe eosinophilic asthma - pediatric
Approved
6/6/19
FDA Approval announced June 6, 2019.
6
FGEN
Pancreatic cancer
Phase 2
1/17/17
Phase 2 abstract released January 17, 2017.
5
IONS
Familial chylomicronemia syndrome (FCS)
CRL
8/27/18
CRL issued August 27, 2018.
5
VERA
IgA Nephropathy
Phase 2b
6/17/23
Phase 2b 36-week presented at ERA 2023 showed that atacicept 150 mg resulted in a delta of 43% versus placebo in mean proteinuria reduction in per-protocol analysis and demonstrated statistically significant stabilization of eGFR versus placebo in this high-risk population. Phase 3 initiated on June, noted June 17, 2023.
6
DMAC
Chronic Kidney Disease
Phase 2
11/4/21
Phase 2 data presented November 4, 2021 reported statistically significant reductions (over 30% decrease) in albuminuria and early signals of potential disease modification with the APRIL and IgA1 biomarkers decreasing 35% and 22%, respectively.
6
HCM
Follicular Lymphoma and Marginal Zone Lymphoma
Phase 2
6/9/23
Phase 2 data from ICML presentation noted that median duration of response (DoR) and progression free survival (PFS) at median follow-up duration of 22.1 months was not reached, noted June 9, 2023.
6
AMPH
Opioid overdose
Approved
3/7/23
Approved March 8, 2023.
6
MAIA
Non-small cell lung cancer (NSCLC)
Phase 2
10/31/23
Phase 2 preliminary efficacy data reported a 100% Disease Control Rate (DCR), noted October 31, 2023.
5
TTNP
Opioid dependence
Approved
5/26/16
CRL issued April 30, 2013. Approved May 26, 2016.
6
BPTS
COVID-19
Phase 2/3
5/25/23
Phase 2/3 data reported that at 28 days the adjusted difference in the proportion of patients with hospital discharge of 11% showed a trend towards a statistically significant difference in BIO101 group versus placebo in ITT population, noted May 25, 2023.
6
KZIA
Glioblastoma (GBM)
Phase 2/3
10/31/23
Phase 2/3 data reported that it did not perform better than the current standards of care in glioblastoma, noted October 31, 2023.
5
ANNX
Huntington’s disease (HD)
Phase 2
6/7/22
Phase 2 data reported that treatment led to complete and durable target engagement, disease progression was stabilized in the overall HD patient population for the entire nine months, and three trial discontinuations were due to treatment, noted June 7, 2022.
6
INO
Glioblastoma (GBM)
Phase 1/2
11/5/19
Phase 1/2 interim PFS data noted 80% (16/20) of MGMT gene promoter methylated patients and 75% (24/32) of unmethylated patients were progression-free at six months.
6
CMMB
Liver Fibrosis
Phase 2a
1/3/23
Phase 2 top-line data reported that trial met its primary endpoints, noted January 3, 2023.
5
ALNY
Primary hyperoxaluria type 1 (PH1)
Phase 3
11/5/21
Phase 3 full results reported a 33 percent and 42 percent mean reduction in POx and predialysis POx from baseline to Month 6. Reduction in POx was evident by Month 1 and persisted through the end of the month 6, noted November 5, 2021.
6
CORT
Cushing's Syndrome
Approved
2/17/12
Approved February 17, 2012.
6
CORT
Long-standing antipsychotic-induced weight gain (APIWG)
Phase 2
12/8/22
Phase 2 data reported that AIWG did not reverse, noted December 8, 2022.
5
AEZS
Adult Growth Deficiency
Approved
12/20/17
Approval announced December 20, 2017.
6
KNSA
Giant cell arteritis (GCA)
Phase 2
10/6/20
Phase 2 trial met endpoints - October 6, 2020.
6
MTNB
Severe hypertriglyceridemia
Phase 2
2/1/21
Phase 2 data released February 1, 2021. Primary endpoint not met.
4
ASND
Growth hormone deficiency in children
Approved
8/25/21
FDA approval announced August 25, 2021.
6