Edgewise Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results with Strong Progress Across Muscular Dystrophy and Cardiovascular Programs

– CIRRUS-HCM 12-week data of EDG-7500 in obstructive and nonobstructive hypertrophic cardiomyopathy (HCM) expected in H1 2026 – – Phase 1 healthy adult trial data of EDG-15400 and plans for heart failure studies expected in H1 2026 – – Pivotal GRAND CANYON results for sevasemten in Becker muscular dystrophy (Becker) expected in Q4 2026 – BOULDER, Colo., Feb.

26, 2026 /PRNewswire/ -- Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the fourth quarter and full year of 2025 and recent business highlights. "Following strong execution in 2025, we have entered a transformative year," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise.

"We remain on track to deliver pivotal GRAND CANYON top-line data for sevasemten, with the potential to support the first marketing application for the treatment of Becker. We also expect CIRRUS-HCM 12-week Part D results for EDG-7500 in HCM in the first half of 2026. Data from Part D will support refinement of our Phase 3 trial strategy in HCM.

With multiple near-term catalysts and a high-performing team, we are closer than ever to delivering transformative medicines for patients living with serious conditions that still lack adequate treatment options and represent significant unmet medical needs." Recent Highlights Muscular Dystrophy Program GRAND CANYON, a global pivotal placebo-controlled cohort in Becker: GRAND CANYON is designed to assess the efficacy and safety of sevasemten over an 18-month period, with North Star Ambulatory Assessment (NSAA) as the primary endpoint.

The study is highly powered to be able to show a statistically significant difference in NSAA versus placebo over 18 months. The Company expects to report top-line data in the fourth quarter of 2026 and is continuing preparations for a potential NDA submission to the U.S. Food and Drug Administration (FDA) for sevasemten in Becker, planned for the first half of 2027.

To learn more about GRAND CANYON, go to clinicaltrials.gov (NCT05291091). 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 in participants with Becker who were previously enrolled in ARCH, or who completed CANYON, GRAND CANYON, or DUNE.

As of December 2025, 99% of eligible participants have enrolled in MESA, with exposures to sevasemten for up to four years. 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 4- to 9-year-old participants with Duchenne in a placebo-controlled dose ranging study, followed by an open-label extension period.

FOX is designed to evaluate the effect of sevasemten on safety, biomarkers of muscle damage and function in 6- to 14-year-old participants with Duchenne who have been previously treated with gene therapy. The Company will continue to collect longer-term safety and functional data in the open-label extensions of LYNX and FOX while it plans for a Phase 3 program.

For more information, go to clinicaltrials.gov to learn more about LYNX (NCT05540860) and FOX (NCT06100887). Cardiovascular Programs CIRRUS-HCM Phase 2 trial in adults with symptomatic 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 evaluated the safety and tolerability of a single oral dose of EDG-7500 in participants with obstructive HCM (oHCM). Parts B and C evaluated fixed doses of EDG-7500 over 28 days in oHCM and nonobstructive HCM (nHCM), respectively. Part D is a 12-week study with an open-label extension including participants with oHCM and nHCM designed to explore dose response and optimization.