| 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 | 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 |
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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