Edgewise Phase 2 CANYON trial meets primary endpoint; sevasemten reduces CK by 28% in Becker muscular dystrophy

Edgewise Therapeutics, Inc.

Primary endpoint met: CK decreased 28% vs placebo over months 6-12 in adults (p=0.02).
Key secondary NSAA showed 1.1-point trend favoring sevasemten (p=0.16); treatment group had more advanced disease at baseline.
TNNI2 biomarker reduced 77% vs placebo (p<0.001); functional tests (10-m walk, stair climb, 100-m) trended positive.
Sevasemten well-tolerated; no new safety concerns in adults or adolescents.
GRAND CANYON pivotal cohort enrollment on track for Q1 2025; 99% of eligible patients entered open-label extension.

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