– MESA open-label extension trial of sevasemten in Becker muscular dystrophy continues to enroll nearly all eligible participants,
– Continuing to advance Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy; on track to provide program update in Q4 2025,
– Initiated Phase 1 healthy adult trial of EDG-15400 for future studies in Heart Failure,
BOULDER, Colo., Nov. 6, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the third quarter of 2025 and recent business highlights.
"With a strong balance sheet, we continue to make great progress on our cardiac and skeletal muscle programs," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. "Planning for success in GRAND CANYON, we are building the commercial infrastructure to support a potential launch of sevasemten in Becker. We recently initiated clinical development of EDG-15400, our new clinical candidate targeting heart failure and we're actively developing Phase 3 trial designs in HCM and Duchenne, while continuing to advance our pipeline through innovative R&D."
Recent Highlights
Muscular Dystrophy ProgramSevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to protect against contraction-induced muscle damage in muscular dystrophies including Becker and Duchenne.
MESA open-label extension trial in adults with Becker: The Company continues to advance MESA, an open-label extension trial that collects long term safety and efficacy data of sevasemten to participants with Becker who were previously enrolled in ARCH, or completed CANYON, GRAND CANYON, or DUNE. As of September 2025, 99% of eligible participants are enrolled in MESA.
GRAND CANYON, a global pivotal placebo-controlled cohort in Becker: In February 2025, the Company completed enrollment in GRAND CANYON, an expansion of the CANYON placebo-controlled trial. The 18-month GRAND CANYON cohort is active in 12 countries, and has enrolled 175 adults, reflective of the Becker community's enthusiasm to have access to a therapy with the potential to stabilize their debilitating decline in function. GRAND CANYON is highly powered to be able to show a statistically significant difference in NSAA versus placebo over 18 months and the Company expects to report topline data in the fourth quarter of 2026. To learn more, go to clinicaltrials.gov (NCT05291091).
LYNX and FOX Phase 2 placebo-controlled trials in boys with Duchenne: LYNX is designed to evaluate the effect of sevasemten on safety, biomarkers of muscle damage and function in four- to nine-year-old participants with Duchenne treated with sevasemten in a three-month placebo-controlled dose ranging study, followed by an open-label extension period. In June 2025, the Company announced encouraging observations across functional measures, including Stride Velocity 95th Centile (SV95C), NSAA and 4 stair-climb, while identifying a dose of 10 mg to evaluate in Phase 3.
FOX is designed to evaluate the effect of sevasemten on safety, biomarkers of muscle damage and function in six- to 14-year-old participants with Duchenne who have been previously treated with gene therapy. FOX participants are on average over 10 years old and four years out from receiving gene therapy. Initial results from the FOX study support that sevasemten 10 mg has the potential to reduce the rate of functional decline.
The Company plans to meet with the FDA to discuss a Phase 3 study design including input on the patient population and endpoints, with plans to initiate a pivotal study in 2026. The Company will continue to collect longer-term safety and functional data in the open-label extensions of LYNX and FOX. For more information, go to clinicaltrials.gov to learn more about LYNX (NCT05540860) and FOX (NCT06100887).
Cardiovascular and Cardiometabolic Programs
EDG-7500 is a novel oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM and other diseases of diastolic dysfunction.
CIRRUS-HCM Phase 2 trial in adults with HCM: The Company is advancing CIRRUS-HCM, a multi-part, open-label trial, in participants with HCM at over 20 clinical sites in the U.S. Part A of the trial was designed to evaluate the safety and tolerability of a single oral dose of EDG-7500 in obstructive HCM (oHCM). Part B and Part C of the trial were designed to evaluate the safety and efficacy of once-daily doses of EDG-7500 for four weeks in participants with oHCM (Part B) and in participants with nHCM (Part C). Part D was designed to evaluate the safety and efficacy of EDG-7500 for 12 weeks in participants with oHCM and nHCM and has achieved strong enrollment. The Company is on track to share a program update in the fourth quarter of 2025, with more comprehensive data expected in the first half of 2026. To learn more about CIRRUS-HCM, visit clinicaltrials.gov, NCT06347159 (Phase 2).
EDG-15400 and Heart Failure: EDG-15400 is a novel oral, selective, cardiac sarcomere modulator, being developed for the treatment of heart failure with preserved ejection fraction (HFpEF), a very common form of heart failure. EDG-15400 is currently being dosed in healthy adults in a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study evaluating safety, tolerability, pharmacokinetics and pharmacodynamics. The Company expects topline results from this study in the first half of 2026. To learn more about this study, go to clinicaltrials.gov (NCT07177066).
Cardiometabolic preclinical ...
