Edgewise submits FDA Phase 3 protocol for EDG‑7500 in hypertrophic cardiomyopathy
Edgewise Therapeutics received encouraging feedback from the FDA after its end‑of‑Phase 2 meeting on EDG‑7500 for symptomatic hypertrophic cardiomyopathy. The company has filed the STRATUS‑HCM Phase 3 protocol, which will enroll about 600 adults and use a tolerability‑based dose escalation that does not rely on echocardiograms. The trial is slated to begin in the fourth quarter of 2026 and will randomize patients 2:1 to drug or placebo for 24 weeks, with peak oxygen consumption as the primary efficacy measure.
Why it matters
Edgewise says the study is on track to start in Q4 2026, which will drive near‑term R&D spending and set the timeline for potential regulatory approval. Investors will need to monitor enrollment progress and interim data for any impact on the company’s valuation.
Key facts
- 1The FDA gave positive feedback after Edgewise’s end‑of‑Phase 2 meeting for EDG‑7500 in hypertrophic cardiomyopathy. prnewswire.com
- 2Edgewise has submitted the STRATUS‑HCM Phase 3 protocol to the FDA. prnewswire.com
- 3The Phase 3 trial will enroll approximately 600 adults with symptomatic HCM, including about 200 obstructive and 400 non‑obstructive patients. prnewswire.com
- 4Patients will start at 50 mg daily, with dose escalation to 100 mg after four weeks and to 150 mg after another four weeks, based on investigator‑assessed tolerability. prnewswire.com
- 5Echocardiograms will be performed only at baseline, week 12 and week 24 for secondary endpoints, not for dose decisions. prnewswire.com
- 6The primary efficacy endpoint is the change in peak oxygen consumption from baseline to week 24. investing.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.