EDG-7500 - (CIRRUS-HCM)

May 22, 2026: Edgewise Therapeutics reported 12-week open-label CIRRUS-HCM data for EDG-7500, a once-daily cardiac sarcomere modulator, in obstructive HCM (oHCM, n=20) and nonobstructive HCM (nHCM, n=33).

In oHCM, 90% achieved a clinically meaningful LVOT gradient improvement, defined as resting LVOT gradient <30 mmHg or Valsalva <50 mmHg. By week 12, resting and Valsalva LVOT gradients fell 55% and 51% from baseline, NT-proBNP decreased 56%, hs-cTnI decreased 40%, KCCQ-OSS improved by 24 points, 70% had at least a 1-class NYHA improvement, 55% reached NYHA class I, and e’ lateral improved by 1.2 cm/s (+20%).

In nHCM, by week 12 NT-proBNP decreased 65%, hs-cTnI decreased 33%, KCCQ-OSS improved by 13 points, 64% had at least a 1-class NYHA improvement, 52% reached NYHA class I, and e’ lateral improved by 1.6 cm/s (+37%).

Safety: 34 patients (64%) had at least 1 TEAE; 23 mild, 9 moderate, 2 severe. There were no related SAEs, 5 unrelated SAEs (9.4%), 2 cases of new AF/AFL (3.8%), no treatment-emergent heart failure, no LVEF below 50%, and no dose reductions for LVEF. The company said Phase 3 remains on track to start in 4Q 2026.