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An Open-Label Extension Study to Assess the Long-term Effect of EDG-5506 on Safety, Biomarkers, and Functional Measures in Adults and Adolescents With Becker Muscular Dystrophy

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Trial Profile

An Open-Label Extension Study to Assess the Long-term Effect of EDG-5506 on Safety, Biomarkers, and Functional Measures in Adults and Adolescents With Becker Muscular Dystrophy

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Sep 2025

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At a glance

  • Drugs Sevasemten (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions
  • Acronyms MESA
  • Sponsors Edgewise Therapeutics

Most Recent Events

  • 26 Jun 2025 According to an Edgewise Therapeutics Media Release, the Company recently completed a successful Type C meeting with the U.S. FDA. While the FDA deemed the CANYON data alone insufficient for an accelerated approval, the Agency reiterated that NSAA is a clinically meaningful endpoint for traditional approval. The FDA encouraged Edgewise to continue to share MESA data and natural history prospective modeling ahead of GRAND CANYON completion.
  • 26 Jun 2025 According to an Edgewise Therapeutics media release, as of the March 2025 data cut, 99% of eligible participants (n=85) are enrolled in MESA.
  • 26 Jun 2025 Results presented in an Edgewise Therapeutics media release.

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