Cogent Biosciences Inc
cogentbio.comCogent Biosciences (NASDAQ: COGT) is a clinical-stage biotechnology company focused on developing precision therapies for genetically defined diseases. The company generates no product revenue as of its 10-K filed 2026-02-17, operating entirely on capital raises and carrying convertible note obligations. Its lead asset is bezuclastinib (CGT9486), a selective KIT tyrosine kinase inhibitor targeting the KIT D816V mutation and other KIT exon 17 mutations, in development for Non-Advanced Systemic Mastocytosis (NonAdvSM), Advanced Systemic Mastocytosis (AdvSM), and advanced gastrointestinal stromal tumors (GIST). The FDA granted Breakthrough Therapy Designation for bezuclastinib in NonAdvSM in October 2025, and orphan drug designation has been granted by both the FDA and EMA for Mastocytosis. A first NDA was submitted in December 2025 for NonAdvSM, with a second NDA for AdvSM expected in the first half of 2026. Cogent licensed exclusive worldwide rights to bezuclastinib from Plexxikon Inc., a Daiichi Sankyo subsidiary. Earlier-stage pipeline assets include CGT4859 (FGFR2/3 inhibitor) in Phase 1, and preclinical JAK2 and KRAS programs.
Products & Services
Bezuclastinib (CGT9486): selective KIT D816V / KIT exon 17 tyrosine kinase inhibitor in NDA review for NonAdvSM and late-stage development for AdvSM and GIST. CGT4859: FGFR2/3 small molecule inhibitor in Phase 1. Preclinical programs targeting JAK2 and KRAS.
Revenue Model
Pre-revenue clinical-stage company. No product sales as of the 10-K filed 2026-02-17. Operations are funded through capital markets activity. The company carries convertible note obligations.
Customers & Markets
Target patient populations: Systemic Mastocytosis (NonAdvSM and AdvSM), advanced and metastatic GIST. Rare and orphan disease end markets. U.S. commercial launch of bezuclastinib for NonAdvSM targeted for second half of 2026, pending FDA approval.
Geographic Exposure
Development activities and planned initial commercial launch in the United States. EMA orphan drug designation obtained, indicating European regulatory engagement. Bezuclastinib licensed on exclusive worldwide rights basis from Plexxikon Inc.
Financial Snapshot
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