Company | Adaptimmune Therapeutics |
Stock Quote | NASDAQ: ADAP |
Study Name | Afami-cel |
Treatment | advanced synovial sarcoma |
Status | Biologics License Application (BLA) |
Catalyst Date | August 4, 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 | Ascendis Pharma |
Stock Quote | NASDAQ: ASND |
Study Name | TransCon PTH |
Treatment | Adult Hypoparathyroidism |
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 | Travere Therapeutics |
Stock Quote | NASDAQ: TVTX |
Study Name | FILSPARI |
Treatment | endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression |
Status | supplemental New Drug Application (sNDA) |
Catalyst Date | September 5, 2024 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Avadel Pharmaceuticals |
Stock Quote | NASDAQ: AVDL |
Study Name | LUMRYZ (sodium oxybate) |
Treatment | extended-release sodium oxybate medication |
Status | supplemental New Drug Application (sNDA) |
Catalyst Date | September 7, 2024 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Iterum Therapeutics |
Stock Quote | NASDAQ: ITRM |
Study Name | sulopenem etzadroxil/probenecid |
Treatment | Uncomplicated urinary tract infections (uUTIs) |
Status | Phase 3 |
Catalyst Date | September 9, 2024 |
Catalyst | FDA Meeting |
Announcement | Read More |
Website | Click Here |
Company | Heron Therapeutics |
Stock Quote | NASDAQ: HRTX |
Study Name | ZYNRELEF (bupivacaine and meloxicam HTX-011) |
Treatment | Postoperative pain |
Status | Phase 3 |
Catalyst Date | September 23, 2024 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Merck |
Stock Quote | NYSE: MRK |
Study Name | KEYNOTE-483 |
Treatment | for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. |
Status | supplemental Biologics License Applications (sBLA) Priority Review |
Catalyst Date | September 25, 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 | Sanofi |
Stock Quote | NASDAQ: SNY |
Study Name | Dupixent (dupilumab) |
Treatment | moderate-to-severe asthma |
Status | supplemental Biologics License Applications (sBLA) |
Catalyst Date | September 27, 2024 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Sanofi |
Stock Quote | NASDAQ: SNY |
Study Name | isatuximab |
Treatment | Transplant-ineligible newly diagnosed multiple myeloma (NDMM). |
Status | supplemental Biologics License Applications (sBLA) Priority Review |
Catalyst Date | September 27, 2024 |
Catalyst | PDUFA Date |
Announcement | N/A |
Website | Click Here |
Company | NeuroOne Medical Technologies |
Stock Quote | NASDAQ: NMTC |
Study Name | ICD-10 |
Treatment | sEEG RF Ablation |
Status | N/A |
Catalyst Date | October 1, 2024 |
Catalyst | Data Presentation |
Announcement | Read More |
Website | Click Here |
Company | PTC Therapeutics |
Stock Quote | NASDAQ: PTCT |
Study Name | Upstaza |
Treatment | Aromatic L-amino acid decarboxylase (AADC) deficiency |
Status | Biologics License Applications (BLA) |
Catalyst Date | November 13, 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 | 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 | 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 | 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 | 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 |
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