Why Is Cogent Biosciences Stock Trading Higher On Monday?

Core Insights - Cogent Biosciences, Inc.'s bezuclastinib demonstrated significant clinical benefits for patients with non-advanced systemic mastocytosis, supporting plans for FDA approval by the end of 2025 [1][4] Group 1: Clinical Trial Results - The SUMMIT trial achieved its primary endpoint with a statistically significant mean change in total symptom score (TSS) at 24 weeks, showing a mean reduction of 24.3 points in the bezuclastinib arm compared to 15.4 points in the placebo arm, resulting in a placebo-adjusted improvement of 8.91 points [5] - Statistically significant benefits were observed across all key secondary endpoints, including a reduction in serum tryptase, where 87.4% of bezuclastinib-treated patients had a ≥50% reduction compared to none in the control arm [6] Group 2: Future Plans and Financials - Cogent plans to submit its first new drug application (NDA) for bezuclastinib in NonAdvSM by the end of 2025 and will present detailed results from the SUMMIT trial at a medical meeting later this year [4][6] - The company is also on track to provide topline results from the PEAK and APEX trials in the second half of 2025, with a cash balance of $237 million and access to an additional $350 million through a debt facility [7] Group 3: Market Reaction - Following the positive trial results, COGT stock rose by 15.7% to $8.77 during the premarket session [8]