Cogent Biosciences, Inc.

Cogent Biosciences, Inc. is a clinical-stage biotechnology company that develops precision therapies for genetically defined diseases. The company's most advanced program is bezuclastinib (also known as CGT9486), a highly selective tyrosine kinase inhibitor. Bezuclastinib is designed to inhibit the KIT D816V mutation and other mutations in KIT exon 17. The KIT D816V mutation drives Systemic Mastocytosis ("SM"), a rare disease, and exon 17 mutations are found in patients with advanced gastrointestinal stromal tumors ("GIST"). Cogent Biosciences is developing bezuclastinib to treat patients with Non-Advanced Systemic Mastocytosis ("NonAdvSM"), Advanced Systemic Mastocytosis ("AdvSM"), and GIST. In 2025, the company reported positive top-line results from registrational trials for these indications. Cogent Biosciences plans to launch bezuclastinib commercially in the United States in the second half of 2026, subject to regulatory approval. The company also has an ongoing Phase 1 study for its internally developed FGFR2/3 inhibitor and has started a Phase 1 study for its CNS-penetrant, selective mutant ErbB2 inhibitor. Additionally, the Cogent Research Team is developing a portfolio of novel targeted therapies for mutations in PI3Kα, KRAS, and JAK2.