| 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 | Bristol-Myers Squibb |
| Stock Quote | NYSE: BMY |
| Study Name | Breyanzi (lisocabtagene maraleucel) |
| Treatment | Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL) |
| Status | supplemental Biologics License Applications (sBLA) |
| Catalyst Date | December 5, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Milestone Pharmaceuticals |
| Stock Quote | NASDAQ: MIST |
| Study Name | Etripamil |
| Treatment | For Treatment in Paroxysmal Supraventricular Tachycardia |
| Status | N/A |
| Catalyst Date | December 13, 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 | Aldeyra Therapeutics |
| Stock Quote | NASDAQ: ALDX |
| Study Name | Reproxalap |
| Treatment | Small-molecule modulator of RASP |
| Status | New Drug Application (NDA) |
| Catalyst Date | December 16, 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 | Atara Biotherapeutics |
| Stock Quote | NASDAQ: ATRA |
| Study Name | Tabelecleucel (tab-cel) |
| Treatment | Post-Transplant Lymphoproliferative Disease (PTLD) |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | January 10, 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 |
| Company | Bristol-Myers Squibb |
| Stock Quote | NYSE: BMY |
| Study Name | Deucravacitinib |
| Treatment | Moderate to severe plaque psoriasis |
| Status | supplemental New Drug Application (sNDA) |
| Catalyst Date | March 6, 2026 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Lantheus |
| Stock Quote | NASDAQ: LNTH |
| Study Name | Piflufolastat F 18 (formerly 8F-DCFPyL) |
| Treatment | Biochemically Recurrent Prostate Cancer (CONDOR) |
| Status | New Drug Application (NDA) |
| Catalyst Date | March 6, 2026 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Arvinas |
| Stock Quote | NASDAQ: ARVN |
| Study Name | Vepdegestrant |
| Treatment | For ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. |
| Status | New Drug Application (NDA) |
| Catalyst Date | June 5, 2026 |
| 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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