| Company | Syndax Pharmaceuticals |
| Stock Quote | NASDAQ: SNDX |
| Study Name | Revumenib |
| Treatment | Relapsed/Refractory KMT2Ar Acute Leukemia |
| Status | New Drug Application (NDA) |
| Catalyst Date | December 26, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Rhythm Pharmaceuticals |
| Stock Quote | NASDAQ: RYTM |
| Study Name | IMCIVREE (setmelanotide) |
| Treatment | Obesity and Control of Hunger Associated with POMC |
| Status | supplemental New Drug Application (sNDA) |
| Catalyst Date | December 26, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Checkpoint Therapeutics |
| Stock Quote | NASDAQ: CKPT |
| Study Name | Cosibelimab (cSCC) |
| Treatment | Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC) |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | December 28, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Neurocrine Biosciences |
| Stock Quote | NASDAQ: NBIX |
| Study Name | crinecerfont |
| Treatment | For the Treatment of Congenital Adrenal Hyperplasia (CAH) |
| Status | New Drug Application (NDA) |
| Catalyst Date | December 30, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Axsome Therapeutics |
| Stock Quote | NASDAQ: AXSM |
| Study Name | AXS-07 |
| Treatment | Acute Treatment of Migraine |
| Status | New Drug Application (NDA) |
| Catalyst Date | January 31, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Vertex Pharmaceuticals |
| Stock Quote | NASDAQ: VRTX |
| Study Name | suzetrigine |
| Treatment | Moderate-to-Severe Acute Pain |
| Status | New Drug Application (NDA) |
| Catalyst Date | January 30, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Supernus Pharmaceuticals |
| Stock Quote | NASDAQ: SUPN |
| Study Name | SPN-830 (apomorphine infusion pump) |
| Treatment | Continuous treatment of motor fluctuations in Parkinson's disease (PD) |
| Status | New Drug Application (NDA) |
| Catalyst Date | February 1, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Merus |
| Stock Quote | NASDAQ: MRUS |
| Study Name | Zenocutuzumab |
| Treatment | Advanced pancreas cancer and other solid tumors harboring NRG1 fusions |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | February 4, 2025 |
| 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 | Phase 3 |
| Catalyst Date | February 28, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Eton Pharmaceuticals |
| Stock Quote | NASDAQ: ETON |
| Study Name | ET-400 |
| Treatment | Hydrocortisone Oral Solution |
| Status | New Drug Application (NDA) |
| Catalyst Date | February 28, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | SpringWorks Therapeutics |
| Stock Quote | NASDAQ: SWTX |
| Study Name | Mirdametinib |
| Treatment | Adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN) |
| Status | New Drug Application (NDA) |
| Catalyst Date | February 28, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | SpringWorks Therapeutics |
| Stock Quote | NASDAQ: SWTX |
| Study Name | Mirdametinib |
| Treatment | Adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN) |
| Status | New Drug Application (NDA) |
| Catalyst Date | February 28, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | scPharmaceuticals |
| Stock Quote | NASDAQ: SCPH |
| Study Name | FUROSCIX |
| Treatment | Decompensated heart failure |
| Status | supplemental New Drug Application (sNDA) |
| Catalyst Date | March 6, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Roivant |
| Stock Quote | NASDAQ: ROIV |
| Study Name | VTAMA (tapinarof) cream |
| Treatment | Plaque psoriasis |
| Status | supplemental Biologics License Applications (sBLA) |
| Catalyst Date | March 12, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Alnylam Pharmaceuticals |
| Stock Quote | NASDAQ: ALNY |
| Study Name | Vutrisiran |
| Treatment | For the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy. |
| Status | supplemental New Drug Application (sNDA) |
| Catalyst Date | March 23, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Soleno Therapeutics |
| Stock Quote | NASDAQ: SLNO |
| Study Name | DCCR |
| Treatment | For patients with Prader-Willi syndrome (PWS). |
| Status | Phase 2 |
| Catalyst Date | March 27, 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 | April 2, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Exelixis |
| Stock Quote | NASDAQ: EXEL |
| Study Name | Cabozantinib |
| Treatment | Neuroendocrine Tumors |
| Status | supplemental New Drug Application (sNDA) |
| Catalyst Date | April 3, 2025 |
| 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) |
| 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 | 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 | 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 |
Recursion Pharmaceuticals is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest....
CLICK TO LEARN MORE