Cogent Biosciences Receives FDA Acceptance for New Drug Application

Cogent Biosciences announced that the U.S. FDA has accepted its New Drug Application for bezuclastinib in patients with NonAdvanced Systemic Mastocytosis and assigned a Prescription Drug User Fee Act target action date of December 30, 2026. In addition, the FDA communicated that at this time, there is no plan to hold an advisory committee, nor have they identified any potential review issues. Clinical results from the pivotal SUMMIT trial with bezuclastinib in NonAdvSM patients demonstrated clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints. 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. In addition, results also showed the benefit of bezuclastinib in populations with high unmet need and bezuclastinib's impact on bone mineral density as well as evidence of disease modification. Across the SUMMIT trial, bezuclastinib demonstrated a favorable safety and tolerability profile, supporting its potential for chronic use in patients with NonAdvSM. Completion of the NDA submission for bezuclastinib in patients with Gastrointestinal Stromal Tumors who have received prior treatment with imatinib remains on track for April 2026. The GIST submission was initiated under Real-Time Oncology Review, and bezuclastinib received Breakthrough Therapy Designation in this indication. The NDA submission for bezuclastinib in patients with Advanced Systemic Mastocytosis remains on track for the first half of 2026.