Cogent Biosciences (NASDAQ:COGT), a pioneering biotechnology company specializing in precision therapies for genetically defined diseases, announced today that it has achieved alignment with the U.S. Food and Drug Administration (FDA) on a novel patient-reported outcome measure.
The measure, known as the Mastocytosis Symptom Severity Daily Diary (MS2D2), will be utilized in Part 2 of the registration-directed SUMMIT trial, which is assessing the efficacy of bezuclastinib in patients with Nonadvanced Systemic Mastocytosis (NonAdvSM).
Enrollment for SUMMIT Part 2 is expected to be completed by the second quarter of 2025, with top-line results anticipated by the end of 2025.