Cogent Biosciences Email Format
Biotechnology ResearchMassachusetts, United States201-500 Employees
Cogent Biosciences is a mid-sized biotechnology company focused on developing precision therapies for genetically defined diseases. Its lead program, bezuclastinib, is designed to selectively inhibit KIT exon 17 mutations, including KIT D816V, mutations linked to Systemic Mastocytosis and to oncogenic KIT signaling in advanced gastrointestinal stromal tumors. By targeting these mutations, the company aims to address clinical needs for patients with these KIT-driven conditions. The firm operates from Waltham, Massachusetts, placing it in the biotechnology research sector. Its early clinical data in a Phase 1/2 trial for advanced GIST showed activity and an acceptable safety profile for bezuclastinib. In March 2026, the FDA accepted the NDA for bezuclastinib in Non-Advanced Systemic Mastocytosis and set a PDUFA target action date for December 30, 2026. The company also maintains a broader pipeline with preclinical programs and has disclosed related data at scientific meetings in 2026, including efforts around other targets such as JAK2 V617F and KRAS/ErbB2 pathways.