Bezuclastinib SUMMIT trial beats all primary/secondary endpoints; NDA submission by end 2025

Cogent Biosciences, Inc.

SUMMIT trial met primary endpoint: mean TSS reduction of 24.3 vs 15.4 placebo (p=0.0002); 8.91-point placebo-adjusted improvement.
87.4% of bezuclastinib patients had ≥50% reduction in serum tryptase vs 0% placebo (p<0.0001).
NDA submission to FDA expected by end of 2025; plan to present full data at medical meeting.
Raised ~$230M gross via offering of 22.2M shares at $9 (plus underwriter option fully exercised).
Cash balance ~$237M as of June 30, 2025; access to up to $350M via debt facility.

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