Preparing for anticipated bezuclastinib launch in GIST; PDUFA action date November 30, 2026NonAdvSM PDUFA target action date December 30, 2026; AdvSM PDUFA target action date June 29, 2027 Cash balance of
WALTHAM, Mass. and BOULDER, Colo., Oct. 27, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ:COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today
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 for June 29, 2027
On track for potential approval of bezuclastinib for GIST patients (PDUFA November 30) and NonAdvSM patients (PDUFA December 30) later this year; AdvSM New Drug Application submitted to FDA on June 30 Completed
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 safety profile for
- JAK2 V671F poster presentation showcases potential best-in-class properties, including improved selectivity compared with currently approved JAK inhibitors - - Selective JAK V617F inhibitor, CGT1145, on track for IND
-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an updated objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria – -- Bezuclastinib
Bezuclastinib combination is first treatment ever to demonstrate statistically significant advantage against active comparator in GIST patients; median PFS of 16.5 months versus 9.2 months (HR=0.50, CI: 0.39-0.65,
NDA acceptance with Priority Review builds upon previous assignment of Breakthrough Therapy Designation and Real-Time Oncology Review following Phase 3 PEAK results; PDUFA date set for November 30, 2026 Bezuclastinib
WALTHAM, Mass. and BOULDER, Colo., May 27, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ:COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today
Pivotal data from APEX trial in Advanced Systemic Mastocytosis accepted for oral presentation; Cogent's third oral presentation of pivotal data with bezuclastinib at major medical meetings Preclinical data from
- Planning for dual launches of bezuclastinib in Systemic Mastocytosis and Gastrointestinal Stromal Tumors (GIST) - Pivotal data from Phase 3 PEAK trial in GIST patients selected for oral presentation at 2026 ASCO
WALTHAM, Mass. and BOULDER, Colo., April 21, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ:COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today
– Updated presentation on Cogent's potent pan-KRAS(ON) inhibitor, CGT1263, showcasing its selectivity profile which could lead to reduction in skin toxicity associated with multi-RAS inhibitors – Updated presentation on
Bezuclastinib NDA submitted under the FDA's RTOR program based on positive results from Phase 3 PEAK trial; bezuclastinib previously granted Breakthrough Therapy Designation in GISTBezuclastinib combination demonstrated
