Edgewise Therapeutics Inc., a biopharmaceutical company focused on muscle diseases, announced significant progress in its regulatory review process for sevasemten, a potential therapy for Becker and Duchenne muscular dystrophies. Following a successful Type C meeting with the U.S. Food and Drug Administration (FDA), Edgewise has outlined a clear path towards the registration of sevasemten as the first-ever therapy for Becker. While the FDA found the existing CANYON data insufficient for accelerated approval, they confirmed that NSAA is a clinically meaningful endpoint for traditional approval. The FDA has shown support for the ongoing GRAND CANYON trial, a pivotal global placebo-controlled study, which is anticipated to produce topline data in the fourth quarter of 2026. This development marks a significant step forward in the potential approval and availability of a new treatment option for patients with Becker muscular dystrophy.