Cogent reports positive top-line results from SUMMIT trial of bezuclastinib in non-advanced systemic mastocytosis

Cogent Biosciences, Inc.

SUMMIT Part 2 met primary endpoint with highly significant mean TSS reduction of 24.3 points vs placebo 15.4 (p=0.0002) at 24 weeks.
87.4% of bezuclastinib patients had ≥50% reduction in serum tryptase vs 0% on placebo (p<0.0001).
All key secondary endpoints achieved statistical significance, including KIT D816V VAF and bone marrow MC aggregates reductions.
Company on track to submit NDA to FDA for bezuclastinib in NonAdvSM by end of 2025; detailed results planned for medical meeting.
Safety profile manageable: most TEAEs low grade, discontinuations due to ALT/AST elevations (5.9%) all resolved.

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