Cogent Biosciences Inc. (NASDAQ:COGT) said the U.S. Food and Drug Administration has accepted its New Drug Application for bezuclastinib as a treatment for patients with non-advanced systemic mastocytosis.
The FDA set a target decision date of December 30, 2026, under the Prescription Drug User Fee Act. The agency also indicated that it does not currently plan to convene an advisory committee to review the application and has not flagged any issues during the early stages of evaluation.
The submission is supported by findings from Cogent’s pivotal SUMMIT clinical trial, which showed improvements across both primary and secondary endpoints in patients suffering from the rare blood disorder. Data collected over 48 weeks also indicated that symptom improvements continued to strengthen over time.
Cogent said it expects to complete another regulatory submission for bezuclastinib in patients with gastrointestinal stromal tumors previously treated with imatinib by April 2026. That application is being processed under the FDA’s Real-Time Oncology Review program, and the therapy has already received Breakthrough Therapy Designation for this use.
The company also plans to submit an additional application for bezuclastinib as a treatment for advanced systemic mastocytosis during the first half of 2026.
Bezuclastinib is designed to block the KIT D816V mutation as well as other mutations in KIT exon 17. The KIT D816V mutation plays a key role in systemic mastocytosis, a condition marked by the uncontrolled growth of mast cells.
Cogent Biosciences, headquartered in Waltham, Massachusetts, and Boulder, Colorado, focuses on developing targeted therapies for diseases driven by specific genetic mutations.