EDG-7500

May 7, 2026 — Edgewise Therapeutics (Nasdaq: EWTX) reported Q1 2026 financial results and pipeline updates. In its Becker muscular dystrophy program, the company highlighted long-term data from the MESA open-label extension showing patients on sevasemten had functional stabilization for up to 3.5 years, contrasting with expected decline from natural history. A new CANYON analysis presented at the 2026 MDA conference reported sevasemten was well tolerated from a cardiac standpoint over 12 months, with no adverse effects on LVEF or NT‑proBNP and evidence of LVEF improvement in certain subgroups.

Edgewise reaffirmed timelines: pivotal GRAND CANYON (18-month, placebo-controlled; primary endpoint NSAA) top-line results expected in Q4 2026, with a potential Becker marketing application planned for 1H 2027. For cardiovascular programs, 12-week Part D data from the CIRRUS-HCM Phase 2 trial of EDG-7500 in obstructive and nonobstructive HCM are expected in Q2 2026, with Phase 3 initiation targeted for 2H 2026; EDG-15400 (Phase 1) is slated for a Phase 2 HFpEF trial in 2H 2026.

Q1 2026: cash ~$499.6M (Mar 31); R&D $42.7M; G&A $11.5M; net loss $49.0M ($0.46/share).