Edgewise Therapeutics provided updates on the Company’s clinical programs (Becker Muscular Dystrophy / Duchenne Muscular Dystrophy) and highlighted major milestones for 2026.
2026 Priorities – Sevasemten
Will complete the GRAND CANYON global pivotal cohort and will announce top-line results in individuals with Becker in the fourth quarter of 2026.
Will prepare for submission of a New Drug Application with the U.S. Food and Drug Administration for sevasemten in Becker in the first half of 2027.
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Will finalize the design and plan for a Phase 3 trial in individuals with Duchenne muscular dystrophy (Duchenne) in the second half of 2026. >>> Learn More: What is Sevasemten?
2025 Accomplishments for Duchenne and Becker
- Completed enrollment of GRAND CANYON in adults with Becker.
- Reported positive top-line data from the MESA Phase 2 open label extension trial in adults with Becker.
- Reported encouraging observations from the LYNX Phase 2 placebo-controlled trial in participants with Duchenne across functional measures, including Stride Velocity 95th Centile (SV95C), North Star Ambulatory Assessment (NSAA) and 4 stair-climb, while identifying a dose of 10 mg to evaluate in Phase 3.
- Reported initial results from the FOX Phase 2 placebo-controlled trial in participants with Duchenne previously treated with gene therapy that also supported that sevasemten 10 mg has the potential to reduce the rate of functional decline.
Read More: Clinical Trials for Duchenne (List of All Researches)
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