Edgewise reports Q3 2026 results, confirms EDG-7500 Phase 3 to start by year-end

Edgewise Therapeutics reported third-quarter 2026 results on November 4, 2026, highlighting progress across its two cardiovascular programs. CEO Kevin Koch said positive CIRRUS-HCM Part D results and a JCI Insight publication reinforce the profile of EDG-7500, and the company expects to initiate its Phase 3 trial by year-end 2026.¹

EDG-7500 is described as an investigational, oral, first-in-class cardiac sarcomere modulator that is designed to act on the regulatory light chain to slow early contraction velocity and improve impaired cardiac relaxation associated with HCM.¹ In August 2026, the company shared positive top-line results from the 12-week Phase 2 Part D CIRRUS-HCM open label trial of EDG-7500 in obstructive and nonobstructive HCM, presented as late-breaking science at the European Society of Cardiology Congress.¹ That trial was designed to inform the planned Phase 3 study.¹ Separately, Edgewise published the preclinical pharmacologic profile of EDG-7500 in JCI Insight, supporting its ability to improve cardiac relaxation while preserving overall systolic performance.¹

In its second program, the company dosed its first patient in the Phase 2 EQUINOX-HFpEF trial, testing EDG-15400 in adults with symptomatic heart failure with preserved ejection fraction and a left ventricular ejection fraction of at least 50%.¹ The study is listed on ClinicalTrials.gov under NCT07795814.

On financials, Edgewise held roughly $1,743.9 million in cash, cash equivalents and marketable securities as of September 30, 2026.¹ The company reported a $1.348 billion gain from the completed sale of its sevasemten program and muscular dystrophy business to Servier in July 2026, which included $1.396 billion in upfront cash proceeds.¹ That transaction drove net income of $1,166.2 million, or $10.71 per basic share, for the quarter, compared with a net loss of $40.7 million in the same period of 2025.¹