Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in NonAdvanced Systemic Mastocytosis

Core Insights - Cogent Biosciences has submitted a New Drug Application (NDA) for bezuclastinib to the FDA for NonAdvanced Systemic Mastocytosis (NonAdvSM), based on positive results from the SUMMIT pivotal trial [1][2] - The NDA submission is part of a broader strategy, with two additional submissions planned for bezuclastinib targeting Gastrointestinal Stromal Tumors (GIST) and Advanced Systemic Mastocytosis (AdvSM) in the first half of 2026 [5] Group 1: Clinical Data and Trial Results - The SUMMIT trial achieved statistical significance across all primary and key secondary endpoints, demonstrating the efficacy of bezuclastinib in patients with NonAdvSM [2] - Bezuclastinib showed significant clinical benefits across 11 individual patient-reported symptoms, with reductions in serum tryptase correlating with symptom severity improvements [3] - Updated data from the SUMMIT trial indicated a continued deepening of symptomatic improvement over 48 weeks, suggesting potential for sustained clinical benefits with longer therapy duration [4] Group 2: Regulatory Designation and Future Plans - Bezuclastinib received Breakthrough Therapy Designation from the FDA in October 2025, highlighting its potential to meet significant unmet medical needs [5] - The company plans to submit NDAs for bezuclastinib in GIST and AdvSM based on strong clinical results from the PEAK and APEX trials, expected in the first half of 2026 [5] Group 3: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [6] - The company is also engaged in developing a portfolio of novel targeted therapies for serious, genetically driven diseases, including ongoing studies for FGFR2/3 inhibitors [6]