Topline results from the GRAND CANYON study show sevasemten did not meet its primary endpoint in Becker muscular dystrophy. The 18-month global placebo-controlled trial found no statistically significant benefit on the North Star Ambulatory Assessment, and secondary endpoints also were not met. The study did demonstrate a continued favorable safety and tolerability profile.
Servier said the results are not aligned with certain findings from prior clinical studies, including the Phase 2 CANYON study, and that it is conducting a comprehensive analysis of the GRAND CANYON dataset together with relevant prior clinical data to better understand and further characterize the findings. Full results will be presented in the future.
Servier acquired sevasemten and Edgewise Therapeutics' muscular dystrophy business in a deal announced June 1, 2026, with an initial purchase price of $1.55 billion in upfront cash, plus up to $1.1 billion in regulatory and commercial milestone payments for total potential consideration of up to $2.65 billion. The transaction closed in the third quarter of 2026.
The GRAND CANYON pivotal cohort enrolled 175 participants with Becker muscular dystrophy and was powered at greater than 98% to deliver a statistically significant difference versus placebo. Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to limit muscle damage caused by the loss of functional dystrophin. It also was being studied in Phase 2 for Duchenne muscular dystrophy.
Following the sale, Edgewise became a cardiovascular-focused company centered on EDG-7500 for hypertrophic cardiomyopathy, EDG-15400 for HFpEF and EDG-003.
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