| 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 | April 21, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Abeona Therapeutics |
| Stock Quote | NASDAQ: ABEO |
| Study Name | pz-cel |
| Treatment | For the treatment of patients with recessive dystrophic epidermolysis bullosa |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | April 29, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Arcutis Biotherapeutics |
| Stock Quote | NASDAQ: ARQT |
| Study Name | ZORYVE™ (roflumilast) |
| Treatment | Inhibitor of phosphodiesterase-4 (PDE4) |
| Status | Phase 3 |
| Catalyst Date | May 22, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | UroGen Pharma |
| Stock Quote | NASDAQ: URGN |
| Study Name | UGN-102 |
| Treatment | Low-grade |
| Status | New Drug Application (NDA) |
| Catalyst Date | June 13, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | KalVista Pharmaceuticals |
| Stock Quote | NASDAQ: KALV |
| Study Name | sebetralstat |
| Treatment | Therapy for hereditary angioedema (HAE). |
| Status | New Drug Application (NDA) |
| Catalyst Date | June 17, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Merck |
| Stock Quote | NYSE: MRK |
| Study Name | KEYNOTE-689 |
| Treatment | In Patients With Resected |
| Status | supplemental Biologics License Applications (sBLA) Priority Review |
| Catalyst Date | June 23, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Regeneron Pharmaceuticals |
| Stock Quote | NASDAQ: REGN |
| Study Name | Linvoseltamab (BCMAxCD3) |
| Treatment | Relapsed/Refractory (R/R) Multiple Myeloma (MM) |
| Status | supplemental Biologics License Applications (sBLA) |
| Catalyst Date | July 10, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Ascendis Pharma |
| Stock Quote | NASDAQ: ASND |
| Study Name | TransCon hGH (Lonapegsomatropin) |
| Treatment | Pediatric Growth Hormone Deficiency (GHD) |
| Status | supplemental Biologics License Applications (sBLA) |
| Catalyst Date | July 27, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Apellis Pharmaceuticals |
| Stock Quote | NASDAQ: APLS |
| Study Name | pegcetacoplan |
| Treatment | Paroxysmal nocturnal hemoglobinuria (PNH) |
| Status | supplemental New Drug Application (sNDA) |
| Catalyst Date | July 28, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Regeneron Pharmaceuticals |
| Stock Quote | NASDAQ: REGN |
| Study Name | Odronextamab |
| Treatment | To treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | July 30, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Tonix Pharmaceuticals |
| Stock Quote | NASDAQ: TNXP |
| Study Name | TNX-102 SL |
| Treatment | Fibromyalgia |
| Status | New Drug Application (NDA) |
| Catalyst Date | August 15, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Ultragenyx Pharmaceutical |
| Stock Quote | NASDAQ: RARE |
| Study Name | UX111 |
| Treatment | For Sanfilippo syndrome type A (MPS IIIA) |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | August 18, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Chimerix |
| Stock Quote | NASDAQ: CMRX |
| Study Name | dordaviprone |
| Treatment | treatment for recurrent H3 K27M-mutant diffuse glioma |
| Status | New Drug Application (NDA) |
| Catalyst Date | August 18, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | PTC Therapeutics |
| Stock Quote | NASDAQ: PTCT |
| Study Name | Vatiquinone (MOVE-FA) |
| Treatment | Friedreich ataxia |
| Status | New Drug Application (NDA) |
| Catalyst Date | August 19, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Regeneron Pharmaceuticals |
| Stock Quote | NASDAQ: REGN |
| Study Name | Aflibercept |
| Treatment | For the treatment of patients with wet age-related macular degeneration (wAMD) |
| Status | supplemental Biologics License Applications (sBLA) Priority Review |
| Catalyst Date | August 19, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Capricor Therapeutics |
| Stock Quote | NASDAQ: CAPR |
| Study Name | deramiocel |
| Treatment | For the treatment of Duchenne muscular dystrophy (DMD) |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | August 31, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Capricor Therapeutics |
| Stock Quote | NASDAQ: CAPR |
| Study Name | deramiocel |
| Treatment | For the treatment of Duchenne muscular dystrophy (DMD) |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | August 31, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Cytokinetics |
| Stock Quote | NASDAQ: CYTK |
| Study Name | Aficamten |
| Treatment | Symptomatic obstructive hypertrophic cardiomyopathy (oHCM) |
| Status | Phase 3 |
| Catalyst Date | September 26, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Unicycive Therapeutics |
| Stock Quote | NASDAQ: UNCY |
| Study Name | Oxylanthanum Carbonate (OLC) |
| Treatment | Symptomatic obstructive hypertrophic cardiomyopathy (oHCM) |
| Status | Phase 1 |
| Catalyst Date | June 28, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Arcutis Biotherapeutics |
| Stock Quote | NASDAQ: ARQT |
| Study Name | ZORYVE™ (roflumilast) |
| Treatment | Inhibitor of phosphodiesterase-4 (PDE4) |
| Status | supplemental New Drug Application (sNDA) |
| Catalyst Date | October 13, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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