Cogent Biosciences, Inc.

Cogent Biosciences, Inc. is a clinical-stage biotechnology company dedicated to developing precision therapies for genetically defined diseases. Headquartered in Waltham, Massachusetts, with an additional office in Boulder, Colorado, the company's mission is to design rational precision therapies that address the underlying causes of disease to significantly improve patients' lives.

The company's primary focus is its lead product candidate, bezuclastinib (CGT9486), a selective tyrosine kinase inhibitor. Bezuclastinib is being developed to target specific mutations within the KIT receptor tyrosine kinase, including the KIT D816V mutation responsible for Systemic Mastocytosis (SM) and KIT exon 17 mutations found in advanced Gastrointestinal Stromal Tumors (GIST). Beyond bezuclastinib, Cogent Biosciences is advancing a pipeline that includes CGT4859, a selective FGFR2 inhibitor in Phase 1 trials for advanced cholangiocarcinoma, and other novel programs targeting ErbB2, PI3Kα, KRAS, and JAK2 V617F mutations.

In recent news, Cogent Biosciences announced the FDA's acceptance of its New Drug Application (NDA) for bezuclastinib in patients with NonAdvanced Systemic Mastocytosis, with a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2026. The company also submitted an NDA for bezuclastinib in Gastrointestinal Stromal Tumors under the FDA's Real-Time Oncology Review program, following positive Phase 3 PEAK trial data that has been selected for oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Andrew Robbins serves as the Chief Executive Officer and President.