2026 | HFSA

Edgewise Therapeutics Announces Positive Top-Line Data from 12-Week Phase 2 CIRRUS-HCM Trial with EDG-7500 in Obstructive and Nonobstructive Hypertrophic Cardiomyopathy (HCM)

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BOULDER, Colo., June 16, 2026 /PRNewswire/ -- Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced positive top-line results from the 12-week Phase 2 Part D CIRRUS-HCM trial of EDG-7500 in obstructive (oHCM) and nonobstructive (nHCM) HCM. EDG-7500 is a novel, oral, selective cardiac sarcomere modulator designed to slow early contraction velocity and improve impaired cardiac relaxation in symptomatic HCM without compromising systolic function. To date, in over 700 echocardiograms performed in healthy adults and patients with HCM, there was no relationship observed between multiple measures of systolic function and concentration of EDG-7500.

CIRRUS-HCM is a multi-part (A-D), open label trial of EDG-7500 in patients with oHCM and nHCM. Part D is a 12-week cohort designed to inform a Phase 3 trial. In oHCM, dosing was guided by left ventricular outflow tract gradient (LVOT-G), while in nHCM, dosing was guided by N-terminal pro-B-type natriuretic peptide (NT-proBNP), a key biomarker of heart failure. Patients in both groups received doses ranging from 25 mg to 150 mg. A total of 53 patients (20 with oHCM and 33 with nHCM) completed Part D 12-week study.