| Company | Applied Therapeutics |
| Stock Quote | NASDAQ: APLT |
| Study Name | AT-007 |
| Treatment | Galactosemia |
| Status | New Drug Application (NDA) |
| Catalyst Date | November 28, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Applied Therapeutics |
| Stock Quote | NASDAQ: APLT |
| Study Name | govorestat |
| Treatment | For the Treatment of Classic Galactosemia |
| Status | New Drug Application (NDA) |
| Catalyst Date | November 28, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | BridgeBio Pharma |
| Stock Quote | NASDAQ: BBIO |
| Study Name | Acoramidis (ATTRibute-CM) |
| Treatment | Symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM) |
| Status | New Drug Application (NDA) |
| Catalyst Date | November 29, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Jazz Pharmaceuticals |
| Stock Quote | NASDAQ: JAZZ |
| Study Name | Zanidatamab |
| Treatment | In HER2+/HR+ Metastatic Breast Cancer |
| Status | Biologics License Applications (BLA) Priority Review |
| Catalyst Date | November 29, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | AstraZeneca |
| Stock Quote | NASDAQ: AZN |
| Study Name | Datopotamab deruxtecan (Dato-DXd) |
| Treatment | Hormone Receptor Positive |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | December 20, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Lexicon Pharmaceuticals |
| Stock Quote | NASDAQ: LXRX |
| Study Name | sotagliflozin |
| Treatment | INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). |
| Status | New Drug Application (NDA) |
| Catalyst Date | December 20, 2024 |
| 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 | 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 | Soleno Therapeutics |
| Stock Quote | NASDAQ: SLNO |
| Study Name | Diazoxide Choline Controlled-Release (DCCR- DESTINY PWS) |
| Treatment | Prader-Willi syndrome (PWS) |
| Status | New Drug Application (NDA) |
| Catalyst Date | December 27, 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 | 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 |
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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