Company | Merck |
Stock Quote | NYSE: MRK |
Study Name | PREVYMIS (letermovir) |
Treatment | non-nucleoside CMV inhibitor |
Status | supplemental New Drug Application (sNDA) Priority Review |
Catalyst Date | June 5, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | 4D Molecular Therapeutics |
Stock Quote | NASDAQ: FDMT |
Study Name | 4D-710 |
Treatment | Cystic fibrosis lung disease |
Status | Phase 1/2 |
Catalyst Date | June 8, 2023 |
Catalyst | Data Presentation |
Press Release | Read More |
Website | Click Here |
Company | Albireo Pharma |
Stock Quote | NASDAQ: ALBO |
Study Name | Bylvay (odevixibat) |
Treatment | Progressive Familial Intrahepatic Cholestasis (PFIC) |
Status | supplemental New Drug Application (sNDA) |
Catalyst Date | June 15, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | argenx |
Stock Quote | NASDAQ: ARGX |
Study Name | Efgartigimod (ADAPT-SC) |
Treatment | Generalized Myasthenia Gravis |
Status | Phase 3 |
Catalyst Date | June 20, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Aldeyra Therapeutics |
Stock Quote | NASDAQ: ALDX |
Study Name | ADX-2191 |
Treatment | Primary vitreoretinal lymphoma (PVRL) |
Status | New Drug Application (NDA) Priority Review |
Catalyst Date | June 21, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Intercept Pharmaceuticals |
Stock Quote | NASDAQ: ICPT |
Study Name | Obeticholic Acid (OCA) and Bezafibrate (BZF) |
Treatment | Primary Biliary Cholangitis (PBC) |
Status | Phase 3 |
Catalyst Date | June 22, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Sarepta Therapeutics |
Stock Quote | NASDAQ: SRPT |
Study Name | SRP-9001 |
Treatment | SRP-9001 (delandistrogene moxeparvovec) |
Status | Biologics License Applications (BLA) |
Catalyst Date | June 22, 2023 |
Catalyst | Data Presentation |
Press Release | Read More |
Website | Click Here |
Company | Bristol-Myers Squibb |
Stock Quote | NYSE: BMY |
Study Name | Mavacamten |
Treatment | symptomatic obstructive hypertrophic cardiomyopathy (oHCM) |
Status | supplemental New Drug Application (sNDA) |
Catalyst Date | June 23, 2023 |
Catalyst | PDUFA Date |
Website | Click Here |
Company | Bausch Health |
Stock Quote | NYSE: BHC |
Study Name | NOV03 (Perfluorohexyloctane) |
Treatment | Dry Eye Disease Associated With Meibomian Gland Dysfunction PRN |
Status | Phase 3 |
Catalyst Date | June 28, 2023 |
Catalyst | PDUFA Date |
Website | Click Here |
Company | BioCardia |
Stock Quote | NASDAQ: BCDA |
Study Name | CardiAMP |
Treatment | Comprehensive biotherapeutic heart failure solution |
Status | Data Safety and Monitoring Board (DSMB) Review |
Catalyst Date | July 12, 2023 |
Catalyst | Data Presentation |
Press Release | Read More |
Website | Click Here |
Company | Verrica Pharmaceuticals |
Stock Quote | NASDAQ: VRCA |
Study Name | VP-102 |
Treatment | molluscum contagiosum (molluscum) |
Status | New Drug Application (NDA) |
Catalyst Date | July 23, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Biogen |
Stock Quote | NASDAQ: BIIB |
Study Name | Zuranolone |
Treatment | Major depressive disorder (MDD) and Postpartum depression (PPD) |
Status | Phase 2 |
Catalyst Date | August 5, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Neurocrine Biosciences |
Stock Quote | NASDAQ: NBIX |
Study Name | Valbenazine (KINECT-HD) |
Treatment | Chorea in Huntington Disease |
Status | supplemental New Drug Application (sNDA) |
Catalyst Date | August 20, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | SpringWorks Therapeutics |
Stock Quote | NASDAQ: SWTX |
Study Name | Nirogacestat |
Treatment | Ovarian Granulosa Cell Tumors |
Status | New Drug Application (NDA) Priority Review |
Catalyst Date | August 27, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | SpringWorks Therapeutics |
Stock Quote | NASDAQ: SWTX |
Study Name | Nirogacestat (DeFi) |
Treatment | Desmoid tumors |
Status | New Drug Application (NDA) |
Catalyst Date | August 27, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Ocuphire Pharma |
Stock Quote | NASDAQ: OCUP |
Study Name | Nyxol |
Treatment | reversal of pharmacologically induced mydriasis (dilation of pupil for eye exams) |
Status | Phase 3 |
Catalyst Date | September 28, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Alnylam Pharmaceuticals |
Stock Quote | NASDAQ: ALNY |
Study Name | Patisiran (APOLLO-B) |
Treatment | Cardiomyopathy of both hereditary and wild-type ATTR amyloidosis |
Status | supplemental New Drug Application (sNDA) |
Catalyst Date | October 8, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Bristol-Myers Squibb |
Stock Quote | NYSE: BMY |
Study Name | Opdivo (nivolumab) |
Treatment | resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting |
Status | supplemental Biologics License Applications (sBLA) |
Catalyst Date | October 13, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Ardelyx |
Stock Quote | NASDAQ: ARDX |
Study Name | tenapanor |
Treatment | control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis |
Status | New Drug Application (NDA) |
Catalyst Date | October 17, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Bausch Health |
Stock Quote | NYSE: BHC |
Study Name | IDP-126 |
Treatment | Acne vulgaris in patients nine years of age and older |
Status | New Drug Application (NDA) |
Catalyst Date | October 20, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Regeneron Pharmaceuticals |
Stock Quote | NASDAQ: REGN |
Study Name | Dupixent (dupilumab) |
Treatment | moderate-to-severe asthma |
Status | supplemental Biologics License Applications (sBLA) Priority Review |
Catalyst Date | October 22, 2023 |
Catalyst | PDUFA Date |
Website | Click Here |
Company | Pacira BioSciences |
Stock Quote | NASDAQ: PCRX |
Study Name | EXPAREL (Bupivacaine Liposome Injectable Suspension) |
Treatment | Postsurgical Analgesia in Children |
Status | New Drug Application (NDA) |
Catalyst Date | November 13, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Aldeyra Therapeutics |
Stock Quote | NASDAQ: ALDX |
Study Name | Reproxalap |
Treatment | Small-molecule modulator of RASP |
Status | New Drug Application (NDA) |
Catalyst Date | November 23, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Ionis Pharmaceuticals |
Stock Quote | NASDAQ: IONS |
Study Name | Eplontersen (formerly AKCEA-TTR-L) |
Treatment | Hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN) |
Status | New Drug Application (NDA) Priority Review |
Catalyst Date | December 22, 2023 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Checkpoint Therapeutics |
Stock Quote | NASDAQ: CKPT |
Study Name | Cosibelimab (cSCC) |
Treatment | Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC) |
Status | Biologics License Applications (BLA) |
Catalyst Date | January 3, 2024 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Company | Minerva Neurosciences |
Stock Quote | NASDAQ: NERV |
Study Name | Roluperidone (MIN-101) |
Treatment | Schizophrenia |
Status | New Drug Application (NDA) |
Catalyst Date | February 26, 2024 |
Catalyst | PDUFA Date |
Press Release | Read More |
Website | Click Here |
Surmodics is the global leader in surface modification technologies for intravascular medical devices and a leading provider of chemical components for in vitro diagnostic immunoassay tests and microarrays. Surmodics is pursuing highly differentiated whole-product solutions that are designed to address...
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