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IPHA
Non-small cell lung cancer (NSCLC)
Phase 2
9/17/21
Phase 2 trial met primary endpoint of confirmed ORR of 30%, and for durvalumab plus monalizumab 36%. The 10-month PFS rate was 64.8% for the durvalumab plus oleclumab combination and 72.7% for durvalumab plus monalizumab, versus 39.2% with durvalumab alone, September 17, 2021.
6
AMGN
Acute lymphoblastic leukemia (ALL) - pediatric
Phase 3
9/24/19
Phase 3 enrolment terminated due to treatment benefit over chemo. Primary endpoint of event-free survival met.
6
ABBV
Alzheimer’s disease
Phase 2
9/7/23
Phase 2 enrollment to be completed, noted September 7, 2023.
5
GILD
Urothelial Cancer
Approved
4/13/21
FDA approval announced April 13, 2021.
6
CGEM
Non-Small Cell Lung Cancer
Phase 1/2
12/16/21
Updated Phase 1/2a reported that 14 patients achieved a confirmed PR for a 39% confirmed response rate and one additional patient had a PR that was pending confirmation at the time of the data cut-off. The median duration of response was >15 months and the median progression free survival was 12 months in the initial cohort of Phase 1 patients, noted December 16, 2021.
6
ABBV
Age-related macular degeneration (AMD)
CRL
6/26/20
CRL issued June 26, 2020.
5
NVS
Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis
Approved
3/21/23
Approved March 21, 2023.
6
REGN
Homozygous familial hypercholesterolemia (HoFH) in children
Approved
3/22/23
Approved March 22, 2023.
6
INCY
Non-Small-Cell Lung Cancer (NSCLC)
Phase 2
5/19/21
Phase 2 data in ASCO abstract noted ORR of 65.6% for the treatment-naive expansion Cohort 7.
6
LLY
Cancer pain
Phase 3
7/28/21
Phase 3 trial met primary endpoint - July 2021.
6
MRNA
Ovarian cancer
Phase 2
8/5/21
Development has been discontinued - noted August 5, 2021.
4
ANNX
Geographic atrophy
Phase 2
7/30/23
Phase 2 results presented at ASRS demonstrated dose and time-dependent protection of visual function in GA across multiple measures, noted July 30, 2023.
6
SWTX
Desmoid tumors
Phase 3
9/10/22
Phase 3 data presented at ESMO resulted in rapid, sustained and statistically significant Improvements in primary and all Key secondary efficacy endpoints, noted September 10, 2022.
6
BPTH
Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
Phase 2
8/1/23
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.
6
PCRX
Postoperative Pain Management
Phase 3
9/21/21
Phase 3 study found the PK profile was comparable across age groups and generally consistent with the profile in adult patients. No safety concerns were identified at a dose of 4 mg/kg, noted September 21, 2021.
6
TNGX
Solid Tumors
Phase 1a
9/6/23
IND cleared by FDA, noted September 6, 2023. Phase 1/2 clinical trial to commence 1H 2024.
5
ETON
Lennox-Gastaut syndrome, epilepsy
CRL
5/27/22
CRL announced May 27, 2022.
5
GILD
Adult patients with r/r ALL - cancer
Approved
10/1/21
Approved October 1, 2021.
6
CALC
Wet age-related macular degeneration
Phase 2b
11/15/21
Additional Phase 2b data reported that the anatomical control was similar to aflibercept over 18 months with BCVA maintained in extension study, noted November 15, 2021.
5
BPMC
Advanced Systemic mastocytosis (SM)
Approved
6/16/21
FDA approval announced June 16, 2021.
6
VYNE
Vitiligo
Phase 1b
10/30/23
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.
6
KTRA
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
AKRO
Nonalcoholic steatohepatitis (NASH)
Phase 2b
10/10/23
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.
6
ALEC
Alzheimer’s disease
Phase 1
11/10/21
Phase 1 data demonstrated target engagement of CD33 in both blood and central nervous system (CNS) compartments at well tolerated doses in healthy volunteers, noted November 10, 2021.
6
AERI
Open Angle Glaucoma
Phase 3
9/24/20
Phase 3 top-line data released September 24, 2020. Non-inferiority to Ganfort achieved.
6
GILD
Nonalcoholic steatohepatitis (NASH)
Phase 2
12/16/19
Phase 2 trial did not meet primary endpoint - December 16, 2019.
4
CGTX
Alzheimer's Disease
Phase 1/2
3/28/23
Additional biomarker data revealed 28 biomarkers that were significantly altered as a result of treatment with CT1812, 11 of which are priority biomarkers of Alzheimer's biology, noted March 28, 2023.
6
ALLO
Non-Hodgkin lymphoma (NHL)
Phase 1
6/15/23
Phase 1 data update presented at ICML and ASCO 23 reported that 7 of 12 (58%) patients achieved a CR and five (42%) maintained a CR through Month 6. Of the five patients who were in CR at 6 months, four (80%) remained in CR, noted June 15, 2023.
6
AGEN
Cervical cancer
BLA Filing
10/22/21
BLA voluntarily withdrawn October 22, 2021.
4
CLSD
Uveal melanoma including choroidal melanoma
Phase 2
2/16/23
Phase 2 safety and efficacy data presented with an average of nine months of follow-up for patients treated with three cycles of therapy showed response to the therapy with 89-100% tumor control, noted February 16, 2023.
6
IGXT
Acute migraine
Approved
4/17/23
Approved April 17, 2023.
6
AQST
Allergic reactions (anaphylaxis)
Phase 2
2/24/23
Phase 2 pharmacokinetic and pharmacodynamic data due presented at AAAAI reported rapid absorption following sublingual administration with the fastest observed median Tmax (12 min forAQST-109, 23 min for EpiPen, and 45 min for IM injection), noted February 24, 2023.
6
AVEO
Hepatocellular carcinoma (HCC)
Phase 1/2
1/20/22
Phase 1b/2 data reported a 27.8% partial response (PR) rate and disease control rate (PR + stable disease) of 67.8%, with a median PFS of 7.3 months and a 1-year OS of 76%, noted January 20, 2022.
5
NKTX
Acute myeloid leukemia / myelodysplastic syndromes
Phase 1
6/27/23
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
MRK
Ebola
Approved
8/3/23
Approval in children aged 12 months and older on August 3, 2023.
6
JAGX
Cancer related diarrhea (CRD)
Phase 2
12/10/21
Phase 2 results reported that CID occurred significantly less (23%) in the crofelemer group during cycle 1 and crofelemer patients were 1.8 times more likely than control patients to have their diarrhea resolved, noted December 10, 2021.
6
ACRS
Rheumatoid arthritis (RA)
Phase 2a
1/19/21
Phase 2a 12-week data released January 19, 2021 - generally well tolerated.
6
EOLS
Aesthetics
Phase 2
1/28/23
Phase 2 interim data presented at the 2023 IMCAS World Congress on indicated that the "extra-strength" formulation at 40U (units) achieved a duration profile of 6 months or 26 weeks, noted January 28, 2023.
6
SELB
Tophaceous gout
Phase 2
9/30/20
Phase 2 top-line data released September 30, 2020. Numerically higher response rate on the primary endpoint during months 3 and 6 combined, but did not meet the primary endpoint of statistical superiority.
4
INDV
Bulimia Nervosa
Phase 2
2/21/19
Phase 2 data released February 21, 2019. Endpoints not met.
4
BLRX
Pancreatic ductal adenocarcinoma (PDAC)
Phase 2
7/17/23
Phase 2b trial initiated, noted July 17, 2023.
5
AZN
COVID-19
Phase 3
11/18/21
Phase 3 separate treatment trial showed an 88% reduced risk of severe COVID-19 or death when treated within three days of symptom onset.
6
ATAI
Generalized Anxiety Disorder (GAD)
Phase 1
4/28/23
Pharmacodynamic data indicated potential for anxiolytic activity without the significant sedative side effects associated with benzodiazepines, noted April 28, 2023.
5
ORIC
Tumors - EGFR/HER2 Exon 20 Inhibitor
Phase 1b
10/23/23
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.
6
ANIP
Menopause symptoms
Approved
9/12/23
Approved September 12, 2023.
6
LGND
Chronic obstructive pulmonary disease (COPD)
Phase 3
12/20/22
ENHANCE-1 Phase 3 topline data met its primary and key secondary endpoints, noted December 20, 2022.
5
GMAB
Non-Hodgkin Lymphoma (NHL)
Phase 1/2
12/14/21
Phase 1/2 data reported that 25% of patients reported Grade 4 Neutropenia, with a 73% CMR and a 27% PMR, noted December 14, 2021.
5
PFE
HIV for adolescents 12 years and older
Approved
3/29/22
Approved March 29, 2022.
6
HRTX
Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)
Approved
8/10/16
CRL Mar 28 2013. Approved August 10, 2016.
6
VTRS
Multiple sclerosis - Tecfidera generic
Approved
8/17/20
FDA approved August 17, 2020.
6
OPK
Obesity and diabetes
Phase 2b
3/21/19
Phase 2b top-line data March 21, 2019 met primary endpoint.
6
ONCT
Metastatic castration-resistant prostate cancer (mCRPC)
Phase 1/2
8/3/23
Phase 1/2 study received "Study May Proceed" letter by FDA, noted August 3, 2023.
5
PFE
Pneumococcal Disease
Approved
4/27/23
Approved on April 27, 2023.
6
CTMX
Solid tumors
Phase 2
3/30/20
Phase 2 trial has been terminated.
4
CYT
Solid tumors, Ovarian cancer
Phase 1
10/12/23
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
SNY
Non-small cell lung cancer (NSCLC)
Phase 3
9/19/21
Phase 3 data presented at ESMO September 19, 2021 showed trial met primary and all secondary endpoints, with an objective response rate of 43%.
6
AGEN
Solid tumors, melanoma
Phase 1
6/3/23
Phase 1 data at ASCO reported an overall response rate (ORR) was 11% (n=2); 37% had SD (n=7) resulting in a disease control rate (DCR) (CR, PR or SD) of 47%, noted June 3, 2023.
5
ANAB
Generalized pustular psoriasis
Phase 3
10/9/23
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.
6
ANAB
Acne
Phase 2
3/14/22
Phase 2 data reported that the trial did not meet the primary or secondary endpoints, noted March 14, 2022.
6
BPMC
RET-fusion non-small cell lung cancer (NSCLC)
Approved
9/4/20
FDA Approval announced September 4, 2020.
6
AZN
Second-line ovarian cancer
Approved
8/17/17
Approval announced August 17, 2017.
6
PULM
Allergic bronchopulmonary aspergillosis in patients with asthma.
Phase 1
7/17/18
Phase 1 Part 3 data released July 17, 2018 - safe and well tolerated
6
CPIX
Pain and fever in patients three months to six months of age
Approved
5/15/23
Expanded label approval by FDA on May 15, 2023.
6
MRK
Neurofibromatosis type 1 plexiform neurofibromas
Approved
4/13/20
FDA Approval announced April 13, 2020.
6
NBIX
Endometriosis
Approved
7/24/18
FDA approval announced July 24, 2018.
6
SNGX
Cutaneous T-Cell Lymphoma (CTCL) cancer
Phase 3
5/4/23
Phase 3 data results confirm and extend response results, noted May 4, 2023.
5
BMY
Non-small cell lung cancer (NSCLC)
Phase 3
10/23/23
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.
6
BHVN
Spinocerebellar Ataxia (SCA)
Phase 3
7/27/23
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.
6
TCDA
Chronic kidney disease
CRL
8/24/20
CRL announced August 24, 2020.
5
MNPR
Oral mucositis
Phase 2/3
3/27/23
Phase 2b/3 interim analysis conducted by an independent Data Safety Monitoring Board (DSMB), which informed the Company that the trial did not meet the pre-defined threshold for efficacy of a 15% absolute difference in SOM prevention between Validive and placebo. Based on not meeting the pre-specified efficacy threshold, the company will be discontinuing the study, noted March 27, 2023.
6
TGTX
Chronic Lymphocytic Leukemia
Phase 1/2
9/20/21
Phase 1/2 data demonstrated that 47 patients have now been treated as of the data cutoff with 57% of patients previously exposed to a BTK inhibitor, best Overall Response Rate (ORR) was 100% amongst evaluable patients (n=46), including 37% complete response (CR) rate presented at iwCLL September 20, 2021.
6
ARDS
Cystic Fibrosis
Phase 2a
3/13/23
Phase 2a trial met primary and secondary endpoints, noted March 13, 2023.
5
NVO
Obesity
Phase 2
6/18/20
Phase 2 primary endpoint met - June 18, 2020.
6
LGND
Chronic obstructive pulmonary disease (COPD)
Phase 2
10/13/21
Phase 2 part B data noted when administered by hand-held pMDI over one week treatment provided clinically meaningful, statistically significant and dose-dependent bronchodilation, noted October 13, 2021.
6
IONS
Amyotrophic lateral sclerosis (SOD1-ALS)
Approved
4/25/23
FDA granted accelerated approval on April 25, 2023.
6
EIGR
COVID-19
Phase 3
3/17/22
Phase 3 top-line data reported a probability of superiority of 99.91%, with a 60% reduced risk of COVID-19-related death, noted March 17, 2022.
6
TPST
Hepatocellular Carcinoma (HCC), Solid tumors
Phase 1/2
4/17/23
Additional biomarker data presented at AACR reported on-target changes in gene signatures in the peripheral blood that were dependent upon drug exposure levels, noted April 17, 2023.
6
REGN
Eosinophilic esophagitis (EoE) in 1-11 year olds
Phase 3
7/14/22
Phase 3 data reported that trial met its primary endpoint, noted July 14, 2022.
5
MRK
Pancreatic cancer
Approved
12/30/19
FDA Approval announced December 30, 2019.
6
XFOR
Waldenström macroglobulinemia
Phase 1b
12/13/21
Phase 1b data of 16 patients enrolled demonstrated that 14 were evaluable as of the data cut, all at low- (200 mg) and mid-level (400 mg) dosing; median duration of treatment was 272.5 days (range 33-435 days); 12 patients remain on study. CXCR4 antagonism proof of concept established, with 100% overall response rate.
6
LLY
Crohn's disease
Phase 3
10/12/23
Phase 3 trial met the co-primary and all major secondary endpoints, noted October 12, 2023.
5
FATE
B-cell Leukemias and Lymphomas
Phase 1
12/10/22
Phase 1 interim data reported that 1 of 2 patients naïve to CAR T-cell therapy achieved an objective response (1 CR) at Day 30, and 2 of 6 patients previously treated with CAR T-cell therapy achieved an objective response (1 CR, 1 PR) at Day 30, noted December 12, 2022.
6
AMGN
Immune Thrombocytopenia (Pediatric)
Approved
12/14/18
FDA approval announced December 14, 2018.
6
ERAS
Glioblastoma Multiforme
Phase 1
6/22/23
DA granted orphan drug designation (ODD), noted June 22, 2023.
5
LUMO
Pediatric Growth Hormone Deficiency (PGHD)
Phase 2
6/21/23
Phase 2 interim data shared at KOL demonstrate a durable response to LUM-201 from 6 to 12 months, noted June 21, 2023.
6
LPTX
Gastric / Gastroesophageal Junction Cancer
Phase 2
6/5/23
Phase 2 data shared at ASCO reported that the median overall survival (OS) was 19.5 months and median progression-free survival (PFS) was 11.3 months, noted June 5, 2023.
5
INVA
Beta thalassemia patients suffering from iron overload
Phase 3
11/25/19
Development to be discontinued due to lack of efficacy - November 25, 2019.
4
MNKKQ
Hepatorenal syndrome (HRS) Type 1
CRL
2/22/22
CRL reissued February 22, 2022.
5
HRMY
Adult Epilepsy Patients with Refractory Focal Seizures
Phase 2
8/7/17
Phase 2 data released August 7, 2017 - endpoints not met.
4
MYOV
Endometriosis-associated pain
Approved
8/5/22
Approved August 5, 2022.
6
VTGN
Major depressive disorder (MDD)
Phase 1
6/21/23
Phase 1 study results showed that dosing was well-tolerated and demonstrated a favorable safety and tolerability profile across single and multiple dose intranasal administrations, noted June 21, 2023.
6
DTIL
Relapsed or refractory B-cell precursor acute lymphoblastic leukemia and R/R non-hodgkin lymphoma
Phase 1/2
6/8/22
Phase 1/2 clinical update reported an 100% ORR, 73% CR rate and 50% durable response rate greater than six months, noted June 8, 2022.
5
BMY
Symptomatic Obstructive Hypertrophic Cardiomyopathy (HCM)
Approved
6/16/23
FDA Approval on June 16, 2023
6
PFE
Amyotrophic lateral sclerosis (ALS)
Phase 3
9/29/22
Phase 3 trial did not meet its primary endpoint, noted September 29, 2022.
6
BNOX
Post-Traumatic Stress Disorder (PTSD)
Phase 2b
9/28/23
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.
6
TAK
Eosinophilic esophagitis
CRL
12/21/21
CRL December 21, 2021.
5
ARGX
Pemphigus foliaceous and vulgaris (PV)
Phase 2
6/20/18
Phase 2 interim data released June 20, 2018, disease control observed in 4/6 patients.
6
GILD
Hepatitis B virus (HBV) infection in pediatric patients 12 years of age and older
Approved
11/2/22
Approved November 2, 2022.
6
JNJ
Waldenström’s Macroglobulinemia
Approved
8/27/18
FDA approval announced August 27, 2018.
6
HALO
Multiple Myeloma
Approved
12/1/21
Approved December 1, 2021.
6