| Cogent Biosciences, Inc.: Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM) | NDA supported by positive results from the APEX pivotal trial demonstrating clinically meaningful responses and evidence of disease modification in patients with AdvSM PDUFA target action date set... ► Artikel lesen |
| Cogent Biosciences, Inc.: Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM) | Submission based on results of APEX pivotal trial which demonstrated bezuclastinib objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria with a well-tolerated... ► Artikel lesen |
| Cogent Biosciences, Inc.: Cogent Biosciences Announces Preclinical Data from Novel JAK2 V617F Inhibitor at the 2026 European Hematology Association (EHA) Congress | - JAK2 V671F poster presentation showcases potential best-in-class properties, including improved selectivity compared with currently approved JAK inhibitors - - Selective JAK V617F inhibitor, CGT1145... ► Artikel lesen |
| Enliven Therapeutics, Inc.: Enliven Therapeutics Appoints Kristine Ball to Board of Directors Ahead of Planned Phase 3 Trial Initiation this Year | Accomplished biopharmaceutical executive with extensive experience in corporate strategy, finance and commercial readiness
Enliven continues preparation for late-stage... ► Artikel lesen |
| Enliven Therapeutics, Inc.: Enliven Therapeutics Announces FDA Alignment on ENABLE-2 Phase 3 Trial Design for Relcobatinib (ELVN-001) in Previously Treated Chronic Myeloid Leukemia | Enliven remains on track to initiate ENABLE-2 before year-end 2026
BURLINGAME, Calif., Oct. 6, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company)... ► Artikel lesen |
| Enliven Therapeutics, Inc.: Enliven Therapeutics Announces Pricing of Upsized Public Offering of Common Stock and Pre-Funded Warrants | BURLINGAME, Calif., June 11, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company... ► Artikel lesen |
| Mineralys Therapeutics, Inc.: Mineralys Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update | - PDUFA target date of December 22, 2026 for lorundrostat; commercial preparations on-track for launch upon approval - - Appoints accomplished cardiovascular medicine executive Dr. Terry Ferguson... ► Artikel lesen |
| Mineralys Therapeutics, Inc.: Mineralys Therapeutics Announces Repurchase of Royalty Obligations in Tanabe License Agreement and Concurrent Financing | - Repurchase of lorundrostat royalty obligation in Tanabe license agreement for $200 million upfront and up to $100 million once certain commercial milestones are met - - $500 million committed... ► Artikel lesen |
| Mineralys Therapeutics, Inc.: Mineralys Therapeutics Presents New Data from the Phase 3 Launch-HTN Trial of Lorundrostat in Participants with Hypertension and Chronic Kidney Disease at European Meeting on Hypertension and Cardiovascular Protection ... | - Post hoc analysis from pivotal Launch-HTN trial shows statistically significant and clinically meaningful reductions in blood pressure in participants with chronic kidney disease - - In participants... ► Artikel lesen |