India, July 7 -- Shares of Cogent Biosciences, Inc. (COGT) were gaining around 27 percent in the pre-market activity on the Nasdaq after the company announced Monday positive top-line results from the SUMMIT clinical trial of bezuclastinib in patients with non-advanced systemic mastocytosis or NonAdvSM.
Based on these data, the biotechnology company said it is on track to submit its first new drug application or NDA to the U.S. Food and Drug Administration for bezuclastinib in NonAdvSM by the end of 2025.
The results from the registration-directed Part 2 of the SUMMIT trial demonstrated clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints, including patient-reported sym...