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
Latest Information Update: 12 Dec 2025
At a glance
- Drugs Sevasemten (Primary)
- Indications Duchenne muscular dystrophy
- Focus Adverse reactions
- Acronyms MESA
- Sponsors Edgewise Therapeutics
Most Recent Events
- 06 Nov 2025 According to an Edgewise Therapeutics Media Release, trial of sevasemten in Becker muscular dystrophy continues to enroll nearly all eligible participants.
- 02 Oct 2025 According to an Edgewise Therapeutics Media Release, company announced its participation at the 30th International Annual Congress of the World Muscle Society (WMS). The symposium will also include a discussion of the results from the CANYON and MESA trials of sevasemten in participants with Becker.
- 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.