Meetings & Presentations2026-10-09

EDG-15400 - (EQUINOX)

Edgewise Therapeutics Inc.EWTX
Indication
Symptomatic heart failure with preserved ejection fraction (HFpEF) who have a left ventricular ejection fraction (LVEF) of at least 50%
Stage
phase2
Event
End of Phase Meeting
Details

October 8, 2026: Edgewise Therapeutics (NASDAQ: EWTX) announced first-patient dosing in EQUINOX-HFpEF, a Phase 2 randomized, double-blind, placebo-controlled trial of EDG-15400 in adults with symptomatic HFpEF and left ventricular ejection fraction of at least 50%.

EDG-15400 is an investigational oral selective cardiac sarcomere modulator. The Phase 2 study will assess safety, tolerability, pharmacokinetics, and pharmacodynamics, with planned enrollment of about 90 patients ages 30-84 with NYHA class II/III symptoms. Participants will receive once-daily 25 mg or 50 mg EDG-15400, or placebo, for up to 12 weeks.

The release cites preclinical evidence of improved diastolic function and says Phase 1 first-in-human data showed favorable pharmacokinetics, pharmacodynamics, and tolerability in healthy adult participants, but no numerical data were provided.

Upcoming catalysts at the HFSA Annual Scientific Meeting 2026 in Phoenix: an ePoster on the EQUINOX-HFpEF trial design on October 10, 2026, and a rapid-fire oral presentation of EDG-15400 Phase 1 data on October 12, 2026.