Cogent Biosciences files NDA for bezuclastinib, targeting rare disease with potential 2026 approval milestone.
Cogent Biosciences (NASDAQ:COGT) filed a New Drug Application with the U.S. FDA for bezuclastinib, a treatment for Advanced Systemic Mastocytosis. The submission follows positive results from the APEX pivotal trial, supporting the drug’s potential approval.
The company expects initial approvals by the end of 2026, pending FDA review. Earlier this month, Cogent also presented preclinical data for a JAK2 inhibitor at the European Hematology Association Congress, highlighting progress in targeting mutation-driven diseases.
CEO Andrew Robbins emphasized the team’s rapid submission of data from three pivotal trials in under a year, positioning the company for potential leadership in rare disease therapies.