Cogent Biosciences, Inc. (NASDAQ: COGT) shares were virtually unchanged Monday. The Waltham, Mass.-based company today announced positive top-line results from the registration-directed APEX Part 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) demonstrating clinically meaningful results as measured by consensus criteria used to assess patient response.
This is the third positive pivotal trial result for bezuclastinib in 2025, following positive announcements from the SUMMIT trial in NonAdvSM patients and the PEAK trial in GIST patients earlier this year. Based on these top-line data, Cogent expects to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in AdvSM during the first half of 2026.
In addition, Cogent plans to present detailed data from the APEX trial at an upcoming scientific meeting in the first half of 2026.
Said CEO Andrew Robbins, “We are excited to announce the third positive pivotal trial for bezuclastinib this year. The results from the APEX trial demonstrate the clear benefit that a highly selective, highly potent KIT mutant inhibitor is capable of providing to patients with AdvSM.
“Coupling rapid, deep, durable responses with the safety and tolerability profile demonstrated by bezuclastinib provides these patients with a new choice to fight their disease without compromising their quality of life. With positive results from APEX, taken together with data from SUMMIT and PEAK, Cogent is preparing for multiple commercial launches in the second half of 2026.”
COGT shares eked up 3.5 cents to $38.80.
