Overview
- An interim Part D update found EDG-7500 was generally well tolerated in 20 participants who completed 12 weeks of dosing.
- No clinically meaningful changes in left ventricular ejection fraction were observed, with no declines below 50% and no atrial fibrillation events reported.
- Edgewise says the drug continues to show a differentiated LVEF profile relative to cardiac myosin inhibitors.
- Parts B and C have completed dosing across 25 mg, 50 mg, and 100 mg cohorts with 43 total participants, including evidence of activity on key HCM markers at the 25 mg dose.
- Edgewise remains on track to deliver full Part D efficacy and safety data in Q2 2026 and to initiate Phase 3 by year-end 2026, as the FDA’s approval of Cytokinetics’ Myqorzo this week reshapes the competitive landscape and EWTX shares rose 17.96% to $25.65 at publication.