Cogent Biosciences presented six posters detailing additional clinical data from its SUMMIT trial evaluating bezuclastinib, a KIT inhibitor being developed for systemic mastocytosis, at the 2026 American Academy of Allergy, Asthma & Immunology Annual Meeting. The data demonstrated that bezuclastinib achieved a mean total symptom score (TSS) reduction of 32.0 points at 48 weeks, with 99% of patients achieving greater than 50% reduction in serum tryptase levels and 83% achieving normalization of tryptase levels.
The clinical findings revealed consistent symptomatic improvements across multiple organ systems affected by the disease, while also providing evidence of disease modification in patients with NonAdvanced Systemic Mastocytosis (NonAdvSM). These results build on the company's regulatory progress, with a New Drug Application (NDA) for bezuclastinib in NonAdvSM submitted to the U.S. Food and Drug Administration in December 2025.
Cogent Biosciences anticipates submitting an additional NDA under the Accelerated Approval pathway for advanced systemic mastocytosis during the first half of 2026. The expanded data presentation represents a key milestone in the clinical development program ahead of potential regulatory decisions on the candidate therapy.