Cogent Biosciences Inc. (NASDAQ: COGT) announced the U.S. Food and Drug Administration has accepted its New Drug Application for bezuclastinib to treat patients with non-advanced systemic mastocytosis.

The FDA assigned a target action date of December 30, 2026, under the Prescription Drug User Fee Act. The agency indicated it does not plan to hold an advisory committee meeting and has not identified potential review issues at this time.

The application is based on results from the company's pivotal SUMMIT trial, which demonstrated improvements across primary and secondary endpoints in patients with the rare blood disorder. The 48-week data showed continued symptomatic improvement over time.

Cogent expects to complete its drug application for bezuclastinib in gastrointestinal stromal tumor patients who received prior imatinib treatment by April 2026. That submission was initiated under the FDA's Real-Time Oncology Review program, and the drug received Breakthrough Therapy Designation for this indication.

The company also plans to submit an application for bezuclastinib in advanced systemic mastocytosis patients during the first half of 2026.

Bezuclastinib is designed to inhibit the KIT D816V mutation and other mutations in KIT exon 17. The KIT D816V mutation drives systemic mastocytosis, a disease caused by uncontrolled proliferation of mast cells.

The biotechnology company, based in Waltham, Massachusetts and Boulder, Colorado, focuses on developing precision therapies for genetically defined diseases.