| Company | Aquestive Therapeutics |
| Stock Quote | NASDAQ: AQST |
| Study Name | Libervant (diazepam) |
| Treatment | epileptic seizures |
| Status | New Drug Application (NDA) |
| Catalyst Date | April 28, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Neurocrine Biosciences |
| Stock Quote | NASDAQ: NBIX |
| Study Name | INGREZZA (Valbenazine) |
| Treatment | Tardive Dyskinesia |
| Status | New Drug Application (NDA) |
| Catalyst Date | April 30, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Day One Biopharmaceuticals |
| Stock Quote | NASDAQ: DAWN |
| Study Name | Tovorafenib |
| Treatment | for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG) |
| Status | N/A |
| Catalyst Date | April 30, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | X4 Pharmaceuticals |
| Stock Quote | NASDAQ: XFOR |
| Study Name | Mavorixafor (X4P-001 - WHIM) |
| Treatment | WHIM syndrome |
| Status | New Drug Application (NDA) |
| Catalyst Date | April 30, 2024 |
| 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 | Phase 2 |
| Catalyst Date | May 23, 2024 |
| 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 | May 25, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Abeona Therapeutics |
| Stock Quote | NASDAQ: ABEO |
| Study Name | pz-cel |
| Treatment | Patients with recessive dystrophic epidermolysis bullosa |
| Status | Phase 3 |
| Catalyst Date | May 25, 2024 |
| Catalyst | Biologics License Application (BLA) |
| Announcement | Read More |
| Website | Click Here |
| Company | Catalyst Pharmaceuticals |
| Stock Quote | NASDAQ: CPRX |
| Study Name | FIRDAPSE® |
| Treatment | for the treatment of LEMS |
| Status | supplemental New Drug Application (sNDA) |
| Catalyst Date | June 4, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Genfit |
| Stock Quote | NASDAQ: GNFT |
| Study Name | elafibranor |
| Treatment | for the treatment of patients with the rare cholestatic liver disease |
| Status | New Drug Application (NDA) |
| Catalyst Date | June 10, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Amgen |
| Stock Quote | NASDAQ: AMGN |
| Study Name | Tarlatamab |
| Treatment | Small cell lung cancer (SCLC) |
| Status | Biologics License Applications (BLA) Priority Review |
| Catalyst Date | June 12, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Bristol-Myers Squibb |
| Stock Quote | NYSE: BMY |
| Study Name | Repotrectinib |
| Treatment | NTRK Fusion-Positive Advanced Solid Tumors |
| Status | Phase 1/2 |
| Catalyst Date | June 15, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Merck |
| Stock Quote | NYSE: MRK |
| Study Name | KEYTRUDA®(pembrolizumab) |
| Treatment | for the treatment of patients with locally advanced or metastatic urothelial carcinoma |
| Status | supplemental Biologics License Applications (sBLA) |
| Catalyst Date | June 17, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Sarepta Therapeutics |
| Stock Quote | NASDAQ: SRPT |
| Study Name | ELEVIDYS (delandistrogene moxeparvovec-rokl) |
| Treatment | designed to address the underlying cause of Duchenne muscular dystrophy through the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. |
| Status | supplemental Biologics License Applications (sBLA) |
| Catalyst Date | June 21, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Verona Pharma |
| Stock Quote | NASDAQ: VRNA |
| Study Name | Ensifentrine |
| Treatment | Chronic obstructive pulmonary disease (COPD) |
| Status | New Drug Application (NDA) |
| Catalyst Date | June 26, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Arcutis Biotherapeutics |
| Stock Quote | NASDAQ: ARQT |
| Study Name | Roflumilast Cream (ARQ-151 AD) |
| Treatment | Atopic Dermatitis (AD) |
| Status | supplemental New Drug Application (sNDA) |
| Catalyst Date | July 7, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Phathom Pharmaceuticals |
| Stock Quote | NASDAQ: PHAT |
| Study Name | vonoprazan |
| Treatment | for the Treatment of Heartburn Associated with Non-Erosive GERD |
| Status | New Drug Application (NDA) |
| Catalyst Date | July 19, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Humacyte |
| Stock Quote | NASDAQ: HUMA |
| Study Name | Human Acellular Vessel |
| Treatment | Coronary Artery Bypass Grafting |
| Status | Biologics License Applications (BLA) Priority Review |
| Catalyst Date | August 10, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Citius Pharmaceuticals |
| Stock Quote | NASDAQ: CTXR |
| Study Name | LYMPHIR |
| Treatment | Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma |
| Status | Biologics License Application (BLA) |
| Catalyst Date | August 13, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | CymaBay Therapeutics |
| Stock Quote | NASDAQ: CBAY |
| Study Name | seladelpar |
| Treatment | for the Treatment of Primary Biliary Cholangitis Including Pruritus |
| Status | New Drug Application (NDA) |
| Catalyst Date | August 14, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Applied Therapeutics |
| Stock Quote | NASDAQ: APLT |
| Study Name | AT-007 |
| Treatment | Galactosemia |
| Status | New Drug Application (NDA) |
| Catalyst Date | August 28, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Syndax Pharmaceuticals |
| Stock Quote | NASDAQ: SNDX |
| Study Name | Axatilimab |
| Treatment | Chronic Graft Versus Host Disease (cGVHD) |
| Status | Biologics License Applications (BLA) Priority Review |
| Catalyst Date | August 28, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Karuna Therapeutics |
| Stock Quote | NASDAQ: KRTX |
| Study Name | KarXT (xanomeline-trospium) |
| Treatment | Healthy Elderly Volunteers |
| Status | New Drug Application (NDA) |
| Catalyst Date | September 26, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Autolus Therapeutics |
| Stock Quote | NASDAQ: AUTL |
| Study Name | Obe-cel (AUTO1 - ALLCAR19) ALL |
| Treatment | Adult Acute lymphoblastic leukemia (ALL) |
| Status | N/A |
| Catalyst Date | November 16, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| 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 | 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 | 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 |
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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