EDG-15400

May 07, 2026 — Edgewise Therapeutics (Nasdaq: EWTX) reported first-quarter 2026 financial results and provided program updates across muscular dystrophy and cardiovascular indications. In its MESA open-label extension in Becker muscular dystrophy, the company presented long-term sevasemten data (up to 3.5 years) showing stabilization of function versus expected natural-history decline; 99% of eligible participants from prior sevasemten studies enrolled. A new CANYON analysis reported a well-tolerated cardiac profile over 12 months, with no adverse effects on LVEF or NT‑proBNP and evidence of LVEF improvement in certain subgroups.

For the pivotal GRAND CANYON Becker trial (18 months; primary endpoint NSAA), Edgewise expects top-line results in Q4 2026 and is preparing a potential first marketing application in 1H 2027. In cardiovascular, 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 planned for 2H 2026; EDG-15400 remains in Phase 1 with HFpEF Phase 2 planned for 2H 2026.

Financially, cash/marketable securities were $499.6M (Mar 31, 2026); R&D expense $42.7M, G&A $11.5M; net loss $49.0M ($0.46/share).