Edgewise submits STRATUS-HCM Phase 3 protocol for EDG-7500 after favourable FDA meeting

What happened: On 5 November 2026, Edgewise Therapeutics announced favourable feedback from its End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) for EDG-7500, its lead candidate for hypertrophic cardiomyopathy (HCM), the most common inherited heart condition, affecting around one in 500 people. Following the meeting, the company submitted its Phase 3 protocol, STRATUS-HCM, which runs two independent placebo-controlled studies — approximately 200 people with obstructive and 400 with non-obstructive HCM — under a single master protocol, randomising roughly 600 adults 2:1 to EDG-7500 or placebo for 24 weeks, with a long-term extension. The primary endpoint is change in peak oxygen consumption, an objective measure of exercise capacity. The trial is on track to start in the fourth quarter of 2026.

Why it matters: A distinctive feature of the design is that investigators will raise the dose based on how well each patient tolerates the drug (from 50 mg up to 150 mg daily), with no echocardiograms needed to guide dosing decisions — potentially making the therapy easier to use outside specialist heart centres. EDG-7500 is a first-in-class oral cardiac sarcomere modulator: it acts on the regulatory light chain of the heart muscle's contraction machinery to slow contraction velocity and improve the impaired relaxation that characterises HCM, which can cause breathlessness, heart failure and sudden cardiac death. European (EMA) and Japanese (PMDA) regulators gave broadly consistent feedback on the proposed dose-escalation plan.

Read more: Edgewise Therapeutics press release, 5 November 2026