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 combination is first treatment ever to demonstrate statistically significant
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 selective, potent JAK2 V617F program accepted for poster presentation WALTHAM, Mass.
- 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 annual meeting - Ended 1Q 2026 with $866.4 million in cash, sufficient to fund
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 announced that the results from the Phase 3 PEAK trial have been selected for
Bezuclastinib mean TSS reduction deepens to –32.0 points at 48 weeks of treatment with further improvement shown across all measured symptoms 99% of patients achieve >50% reduction in serum tryptase at 48 weeks, with 83% rate of normalization Strong evidence of bezuclastinib’s potential as first