Cogent Biosciences announces FDA meeting, alignment of MS2D2

Cogent Biosciences announced it has reached alignment with the U.S. Food and Drug Administration, FDA, on the Company’s novel patient reported outcome measure, Mastocytosis Symptom Severity Daily Diary, MS2D2, for use in Part 2 of the registration-directed SUMMIT trial evaluating bezuclastinib in Nonadvanced Systemic Mastocytosis patients. Cogent remains on-track to complete enrollment in SUMMIT Part 2 in the second quarter of 2025 and report top-line results by the end of 2025. The Company also remains on track to complete enrollment in the APEX study in patients with Advanced Systemic Mastocytosis (AdvSM) by the end of 2024 and report top-line results mid-2025. Due to rapid enrollment, the Company expects PEAK enrollment to be completed in the third quarter of 2024 with top-line results expected by the end of 2025.