Cogent Biosciences
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Overview
Cogent Biosciences is a publicly traded biotech firm dedicated to designing and developing best-in-class precision therapies for genetically driven diseases, with a core focus on oncology. Its most advanced program, bezuclastinib, has an FDA New Drug Application accepted with a PDUFA date of December 30, 2026, for Non-Advanced Systemic Mastocytosis (NonAdvSM). The company's strategy integrates deep expertise in structural biology, enzymology, and translational science to rationally target well-validated mutations, aiming to improve upon existing therapies with known limitations. Cogent's robust pipeline extends beyond its lead asset into other high-value genetic targets, including FGFR2, ErbB2, and PI3Kα.
Technology Platform
An integrated, rational drug design platform that combines genetic target selection, structural biology, enzymology, and translational science to create best-in-class, orally available small molecule therapies for genetically defined diseases.
Pipeline
14| Drug | Indication | Stage | Watch |
|---|---|---|---|
| CGT9486 plus sunitinib + CGT9486 + Sunitinib + Sunitinib + M... | Advanced Gastrointestinal Stromal Tumors | Phase 3 | |
| Bezuclastinib in combination with sunitinib | Gastrointestinal Stromal Tumors | Phase 2 | |
| Bezuclastinib Tablets (Formulation A) + Bezuclastinib Tablet... | SSM | Phase 2 | |
| bezuclastinib | Advanced Systemic Mastocytosis (AdvSM) | Phase 2 | |
| CGT4859 | Intrahepatic Cholangiocarcinoma (Icc) | Phase 1/2 |