Business
Cogent Biosciences Presents Full SUMMIT Results of Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) at the 67th Annual Meeting of the American Society of Hematology (ASH)
-- Bezuclastinib achieves clear clinical benefit across all symptom domains including significant improvements on 11 individual symptoms plus the most severe
About this update from Cogent Biosciences, Inc.
[{"type":"text","content":"-- Bezuclastinib achieves clear clinical benefit across all symptom domains including significant improvements on 11 individual symptoms plus the most severe symptom at baseline -- -- Bezuclastinib demonstrates that reducing objective measures of disease, including serum tryptase, correlates with improvement in symptom severity; the first time this has been shown in NonAdvSM patients -- -- New 48-week data demonstrate a clear, continued deepening of symptomatic improvement over time -- -- Bezuclastinib demonstrated a favorable safety and tolerability profile supporting chronic use -- -- Granted Breakthrough Therapy Designation for bezuclastinib in October 2025; New Drug Application (NDA) on track for submission in December 2025 -- -- Cogent to host investor conference call and webcast on Monday, December 8, at 8:00 a.m. ET -- WALTHAM, Mass. and BOULDER, Colo., Dec. 06, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ: COGT) today announced complete results from the registration-directed Part 2 of the SUMMIT clinical trial of bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM). As previously reported, bezuclastinib demonstrated clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints. New results further highlight the benefit of bezuclastinib on patient-reported symptoms and objective measures of mast cell burden and demonstrate significant correlation between improvement in disease pathology and patient-reported symptom severity. “We are excited to present additional data from the SUMMIT trial that support our conviction that bezuclastinib will be the best-in-class treatment option for patients with nonadvanced systemic mastocytosis,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We remain on track to submit our first New Drug Application for bezuclastinib in NonAdvSM with the FDA this month and are encouraged by the increased interest in our Expanded Access Program.” “Nonadvanced systemic mastocytosis patients currently have very limited treatment options, and the benefit bezuclastinib demonstrated in the SUMMIT trial across measures of disease pathology and symptomatic improvement is very exciting for this patient population,” said Lindsay Rein, MD, Associate Professor of Medicine in the Division of Hemato...