Edgewise announces positive sevasemten data; FDA provides clear path to first Becker therapy

Edgewise Therapeutics, Inc.

MESA OLE: 99% enrollment (85 participants); NSAA scores improved 0.8 pts over 18 months, diverging from natural history declines.
FDA Type C: NSAA endorsed for traditional approval; CANYON alone insufficient; GRAND CANYON may serve as single pivotal study.
GRAND CANYON on track for topline data Q4 2026; highly powered to show NSAA difference vs placebo over 18 months.
Duchenne Phase 2 LYNX/FOX: 10 mg dose selected for Phase 3; well-tolerated; FOX suggests slower decline in post-gene therapy patients.
Plans to meet FDA Q4 2025 for Phase 3 Duchenne design; pivotal study initiation expected in 2026.

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