| 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 | Outlook Therapeutics |
| Stock Quote | NASDAQ: OTLK |
| Study Name | ONS-5010 / LYTENAVA (Bevacizumab-vikg) |
| Treatment | Wet age-related macular degeneration (wet AMD) |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | December 31, 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 | BioMarin Pharmaceutical |
| Stock Quote | NASDAQ: BMRN |
| Study Name | PALYNZIQ |
| Treatment | In Adolescents with Phenylketonuria |
| Status | Biologics License Applications (BLA) Priority Review |
| Catalyst Date | February 28, 2026 |
| 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 | |
| Catalyst Date | February 28, 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 | Aldeyra Therapeutics |
| Stock Quote | NASDAQ: ALDX |
| Study Name | Reproxalap |
| Treatment | Small-molecule modulator of RASP |
| Status | New Drug Application (NDA) |
| Catalyst Date | March 16, 2026 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Rocket Pharmaceuticals |
| Stock Quote | NASDAQ: RCKT |
| Study Name | KRESLADI |
| Treatment | For severe Leukocyte Adhesion Deficiency-I |
| Status | Phase 1/2 |
| Catalyst Date | March 28, 2026 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Lantheus |
| Stock Quote | NASDAQ: LNTH |
| Study Name | LNTH-2501 |
| Treatment | PET Diagnostic Imaging Kit Targeting Somatostatin Receptor-Positive (SSTR+) Neuroendocrine Tumors (NETs) |
| Status | N/A |
| Catalyst Date | March 29, 2026 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Merck |
| Stock Quote | NYSE: MRK |
| Study Name | KEYNOTE-905 |
| Treatment | Patients with Muscle-Invasive Bladder Cancer |
| Status | supplemental Biologics License Applications (sBLA) Priority Review |
| Catalyst Date | April 7, 2026 |
| Catalyst | PDUFA Date |
| Announcement | 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) Priority Review |
| Catalyst Date | April 8, 2026 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Replimune |
| Stock Quote | NASDAQ: REPL |
| Study Name | RP1 nivolumab |
| Treatment | treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | April 10, 2026 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Cingulate |
| Stock Quote | NASDAQ: CING |
| Study Name | CTx-1301 |
| Treatment | Attention Deficit/Hyperactivity Disorder (ADHD) |
| Status | New Drug Application (NDA) |
| Catalyst Date | May 31, 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 |
| Company | scPharmaceuticals |
| Stock Quote | NASDAQ: MNKD |
| Study Name | FUROSCIX |
| Treatment | Decompensated heart failure |
| Status | supplemental New Drug Application (sNDA) |
| Catalyst Date | July 26, 2026 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Lantheus |
| Stock Quote | NASDAQ: LNTH |
| Study Name | MK-6240 |
| Treatment | PET Imaging Agent Targeting Tau in Alzheimer's Disease |
| Status | New Drug Application (NDA) |
| Catalyst Date | August 13, 2026 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Nuvalent |
| Stock Quote | NASDAQ: NUVL |
| Study Name | zidesamtinib |
| Treatment | ALK-selective inhibitor |
| Status | New Drug Application (NDA) |
| Catalyst Date | September 18, 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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