Cogent Biosciences Inc. (NASDAQ:COGT) shares are up on Monday after the U.S. Food and Drug Administration accepted its drug application for bezuclastinib.

FDA Decision Expected In December 2026

The U.S. Food and Drug Administration (FDA) on Monday accepted Cogent’s New Drug Application (NDA) for bezuclastinib, targeting Non-Advanced Systemic Mastocytosis (Non-AdvSM).

NonAdvSM is a rare, chronic disorder characterized by abnormal mast cell accumulation in different organs in the body.

The Prescription Drug User Fee Act (PDUFA) action date is set for December 30, 2026.

The FDA has indicated no plans for an advisory committee meeting, suggesting a smoother review process.

Encouraging Trial Data

Clinical data from the pivotal SUMMIT trial showed significant improvements across key endpoints for patients treated with bezuclastinib, highlighting its potential for chronic use and favorable safety profile.

Data from the SUMMIT trial through 48 weeks showcased a clear and continued deepening of symptomatic improvement over time, supporting the potential for sustained clinical benefit with longer duration of therapy.

Regulatory ...