Cogent Biosciences

Cogent Biosciences is a Waltham, Massachusetts and Boulder, Colorado company developing precision therapies for genetically defined diseases. Its lead candidate, bezuclastinib, is a selective tyrosine kinase inhibitor of KIT D816V and other KIT mutations. In November 2025 it reported positive top-line SUMMIT results in non-advanced systemic mastocytosis (FDA Breakthrough Therapy designation). In the phase 3 PEAK trial in second-line gastrointestinal stromal tumours (GIST), bezuclastinib plus sunitinib gave a median progression-free survival, assessed by blinded independent central review, of 16.5 months against 9.2 months for sunitinib alone (hazard ratio 0.50), a result the company describes as highly statistically significant. By August 2026 the FDA had accepted the GIST application with priority review and a decision date of 30 November 2026, set a decision date of 30 December 2026 for non-advanced systemic mastocytosis, and received a third application, for advanced systemic mastocytosis, submitted on 30 June 2026. Preclinical programmes include a JAK2 V617F mutant-selective inhibitor, a pan-KRAS(ON/OFF) inhibitor, and selective ErbB2 (HER2), PI3K-alpha and FGFR2 inhibitors. Cogent (formerly Unum Therapeutics) trades on Nasdaq as COGT and reported a pro forma cash balance of 865.9 million US dollars in August 2026.