EDG-15400

Feb. 26, 2026: Edgewise Therapeutics, Inc. (NASDAQ: EWTX) reported Q4/full-year 2025 results and outlined upcoming clinical/regulatory catalysts across sevasemten, EDG-7500, and EDG-15400.

Sevasemten (Becker muscular dystrophy; Duchenne programs): The pivotal, global, placebo-controlled GRAND CANYON trial in Becker is an 18‑month study with North Star Ambulatory Assessment (NSAA) as the primary endpoint; top-line results are expected in Q4 2026. The company is preparing for a potential U.S. FDA NDA submission for sevasemten in Becker planned for H1 2027. The MESA open-label extension (long-term safety/efficacy) is ongoing; as of Dec. 2025, 99% of eligible participants enrolled, with exposure up to four years. Phase 2 Duchenne trials LYNX and FOX are in open-label extensions while the company plans a Phase 3 program.

EDG-7500 (hypertrophic cardiomyopathy): CIRRUS-HCM Phase 2 (multi-part open-label) 12-week Part D data in obstructive and nonobstructive HCM are expected in H1 2026; Phase 3 initiation is planned for H2 2026.

EDG-15400 (heart failure): Phase 1 healthy-adult top-line results are expected in H1 2026; a Phase 2 HFpEF trial is planned for H2 2026.