08:43 AM EDT, 03/16/2026 (MT Newswires) -- Cogent Biosciences ( COGT ) said Monday the US Food and Drug Administration has accepted its marketing application for its experimental therapy, bezuclastinib, in patients with non-advanced systemic mastocytosis.

The Prescription Drug User Fee Act target date is set on Dec. 30. The company said it is not planning to conduct an advisory committee nor foresee review issues at this time.

The approval is based on trial that showed significant improvements across primary and key secondary endpoints, including sustained symptom relief, benefits in high-need populations, positive effects on bone mineral density and evidence of disease modification.

The company said its plans to submit marketing application of bezuclastinib in gastrointestinal stromal tumors and advanced systemic mastocytosis remain on track for April 2026 and H1, respectively.