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Investing.com -- Cogent Biosciences, Inc. (NASDAQ:COGT) stock surged 10% after announcing positive top-line results from its SUMMIT trial of bezuclastinib in patients with non-advanced systemic mastocytosis (NonAdvSM).
The company reported that the trial achieved statistical significance across all primary and key secondary endpoints. Patients treated with bezuclastinib showed a superior mean change in total symptom score at 24 weeks compared to placebo (-24.3 points vs. -15.4 points), representing an 8.91 point placebo-adjusted difference (p=0.0002).
The drug demonstrated a powerful effect on mast cell burden, with 87.4% of bezuclastinib-treated patients achieving at least a 50% reduction in serum tryptase compared to 0% in the placebo group. Additionally, the treatment exhibited a favorable safety and tolerability profile supporting chronic use.
Based on these results, Cogent plans to submit a New Drug Application (NDA) to the FDA by the end of 2025. The company is also on track to share pivotal trial results from its PEAK trial in gastrointestinal stromal tumors and APEX trial in advanced systemic mastocytosis in the second half of 2025.
Most treatment-emergent adverse events were low grade, with hair color change (69.5% vs. 5.0%), altered taste (23.7% vs. 0%), nausea (22.0% vs. 13.3%), and ALT/AST elevations (22.0% vs. 6.6%) being the most frequently reported in the bezuclastinib group compared to placebo.
Cogent reported a strong financial position with a current cash balance of $237 million and access to an additional $350 million via a recently announced debt facility with SLR Capital Partners (WA:CPAP).
The company plans to present detailed results from the SUMMIT trial at an upcoming medical meeting later this year.
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