| 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 | 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 | BioCryst Pharmaceuticals |
| Stock Quote | NASDAQ: BCRX |
| Study Name | ORLADEYO (berotralstat) |
| Treatment | Hereditary angioedema (HAE) |
| Status | New Drug Application (NDA) |
| Catalyst Date | September 12, 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 | Jazz Pharmaceuticals |
| Stock Quote | NASDAQ: JAZZ |
| Study Name | Zepzelca (lurbinectedin) |
| Treatment | Relapsed Small Cell Lung Cancer (SCLC) |
| Status | Phase 3 |
| Catalyst Date | October 7, 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 |
| Company | Syndax Pharmaceuticals |
| Stock Quote | NASDAQ: SNDX |
| Study Name | Revumenib |
| Treatment | Relapsed/Refractory KMT2Ar Acute Leukemia |
| Status | supplemental New Drug Application (sNDA) |
| Catalyst Date | October 25, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Merck |
| Stock Quote | NYSE: MRK |
| Study Name | sotatercept-csrk |
| Treatment | In adults with pulmonary arterial hypertension |
| Status | Biologics License Applications (BLA) Priority Review |
| Catalyst Date | October 25, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | REGENXBIO |
| Stock Quote | NASDAQ: RGNX |
| Study Name | RGX-121 |
| Treatment | MPS II (Hunter Syndrome) |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | November 9, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Ascendis Pharma |
| Stock Quote | NASDAQ: ASND |
| Study Name | TransCon CNP |
| Treatment | In Children with Achondroplasia |
| Status | New Drug Application (NDA) |
| Catalyst Date | November 30, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Kura Oncology |
| Stock Quote | NASDAQ: KURA |
| Study Name | Ziftomenib |
| Treatment | Treatment of genetically defined AML patients with high unmet need |
| Status | New Drug Application (NDA) |
| Catalyst Date | November 30, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Innoviva |
| Stock Quote | NASDAQ: INVA |
| Study Name | Zoliflodacin |
| Treatment | For the Treatment of Uncomplicated Gonorrhea |
| Status | Phase 3 |
| Catalyst Date | December 15, 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 | New Drug Application (NDA) |
| Catalyst Date | December 26, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Denali Therapeutics |
| Stock Quote | NASDAQ: DNLI |
| Study Name | tividenofusp |
| Treatment | For the treatment of Hunter syndrome (MPS II) |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | January 5, 2026 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Aquestive Therapeutics |
| Stock Quote | NASDAQ: AQST |
| Study Name | Anaphylm |
| Treatment | For epinephrine prodrug candidate product |
| Status | New Drug Application (NDA) |
| Catalyst Date | January 31, 2026 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Vanda Pharmaceuticals |
| Stock Quote | NASDAQ: VNDA |
| Study Name | Bysanti |
| Treatment | For the Treatments of Acute Bipolar I Disorder and Schizophrenia |
| Status | New Drug Application (NDA) |
| Catalyst Date | February 21, 2026 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Eton Pharmaceuticals |
| Stock Quote | NASDAQ: ETON |
| Study Name | ET-600 |
| Treatment | For the treatment of an endocrinology |
| Status | New Drug Application (NDA) |
| Catalyst Date | February 25, 2026 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
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