Cogenics Biosciences - to submit APEX NDA in June 2026

Cogent Biosciences, Inc. (NASDAQ: COGT) announced positive top-line results from the APEX Part 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) on December 8, 2025. Based on these findings, the company 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. The APEX trial demonstrated a 57% objective response rate (ORR) per mIWG criteria and an 80% ORR per PPR criteria, indicating significant clinical benefit for patients. Additionally, 89% of patients achieved a ≥50% reduction in bone marrow mast cells or clearance of aggregates, and 91% showed a ≥50% reduction in KIT D816V variant allele frequency.

The drug was well tolerated, with only 14.8% of patients requiring dose reduction and no patients discontinuing due to treatment-related adverse events. Common treatment-related adverse events included hair color change and neutropenia (30.9%, 29.6%), altered taste (28.4%), thrombocytopenia (24.7%), and ALT/AST elevations (20.9%). The median time to achieve response was 2.0 months, and the median duration of response has not yet matured.

Cogent plans to present detailed APEX trial data at an upcoming scientific meeting in the first half of 2026. The company also announced positive results from the SUMMIT and PEAK trials earlier in 2025, positioning bezuclastinib as a potential treatment for multiple indications. With these results, Cogent is preparing for multiple commercial launches in 2026.