| 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 | 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 | 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 |
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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