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Edgewise Therapeutics Reports Positive Results on Sevasemten Program for Becker and Duchenne Muscular Dystrophies
– New open label data in Becker demonstrated sustained disease stabilization up to three years, reinforcing prior clinical findings – – Ongoing pivotal trial
About this update from Edgewise Therapeutics, Inc.
[{"type":"text","content":"– New open label data in Becker demonstrated sustained disease stabilization up to three years, reinforcing prior clinical findings –\n– Ongoing pivotal trial and FDA Type C meeting provide clear path to potential sevasemten registration as the first ever therapy for Becker –\n– Encouraging Phase 2 observations in Duchenne define the dose and inform design for Phase 3 –\n– Edgewise leadership to discuss these updates on Thursday, June 26 at 8:30 a.m. Eastern Time at a virtual investor event –\nBOULDER, Colo., June 26, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today unveiled positive results in its sevasemten program for Becker and Duchenne muscular dystrophies.\n\n \n \n \n \n \n \n\n \nThe Company announced positive data from MESA, an open label extension trial that is providing continued access to sevasemten to participants with Becker who were previously enrolled in ARCH, or completed CANYON, GRAND CANYON, or DUNE. As of the March 2025 data cut, 99% of eligible participants (n=85) are enrolled in MESA.\nThe MESA data demonstrated sustained disease stabilization, reinforcing prior ARCH and CANYON findings. Importantly, CANYON participants who rolled over to MESA showed increased North Star Ambulatory Assessment (NSAA) scores over 18 months (0.8 point improvement from baseline), with a trend toward improvement in placebo participants switching to sevasemten (0.2 point improvement since initiation of sevasemten). During the 18 months of sevasemten treatment, participants' NSAA scores continued to diverge relative to the expected functional declines seen in multiple Becker natural history studies. Further, NSAA scores for ARCH participants who rolled over to MESA remained stable after three years of treatment. Sevasemten continues to demonstrate a favorable safety profile after up to three years of treatment. \n\"We are thrilled with the tremendous excitement from physicians and the patient community around the data on sevasemten to date and their unwavering commitment to our ongoing pivotal program,\" said Joanne Donovan, Ph.D., M.D., Chief Medical Officer. \"We are well positioned to deliver the first ever therapy for individuals with Becker muscular dystrophy.\"\nEdgewise recently completed a successful Type C meeting with the U.S. Food and Drug Admini...