COGT Stock Soars on Phase III Systemic Mastocytosis Study Success

Core Insights - Shares of Cogent Biosciences (COGT) increased by 23.4% following the positive results from a late-stage study of bezuclastinib for treating non-advanced systemic mastocytosis (SM) patients [1][7]. Study Results - The phase III SUMMIT study met all primary and key secondary endpoints, showing significant improvements in the treatment of SM patients with bezuclastinib compared to placebo [2][9]. - Bezuclastinib treatment resulted in a mean total symptom score (TSS) reduction of 24.3 points at 24 weeks, compared to a 15.4-point reduction in the placebo group, leading to a placebo-adjusted improvement of 8.91 points [8]. - 87.4% of patients treated with bezuclastinib experienced a ≥50% reduction in serum tryptase levels, a key biomarker, while no patients in the placebo group achieved this [9]. Safety and Tolerability - Bezuclastinib was reported to be well-tolerated with a favorable safety profile, indicating its potential for chronic use in this patient population [10]. Future Plans - Cogent Biosciences plans to submit a new drug application to the FDA for bezuclastinib by the end of 2025, aiming to establish it as a new standard of care for non-advanced SM [11]. - The company is also evaluating bezuclastinib for advanced SM and gastrointestinal stromal tumors in separate pivotal studies, with top-line data expected in the second half of 2025 [12]. Market Performance - Year-to-date, Cogent Biosciences shares have increased by 19.9%, outperforming the industry, which saw a decline of 1.9% [4].