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Edgewise Therapeutics Advances EDG-7500 to Phase 3 Following 'Positive' HCM Data

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Edgewise Therapeutics (EWTX) phase 2 Cirrus-HCM trial of EDG-7500 met key efficacy and safety endpoints in obstructive and non-obstructive hypertrophic cardiomyopathy, supporting advancement to Phase 3, the company said Tuesday.

The 12-week study showed clinically meaningful improvements in echocardiogram measures, biomarkers, symptoms and functional status across both groups, including 90% of obstructive HCM patients with hemodynamic improvement and significant reductions in NT-proBNP and quality-of-life scores across cohorts.

Edgewise said EDG-7500 was generally well tolerated, with no new safety signals, no meaningful reductions in LVEF below 50% and no observed relationship between drug exposure and LVEF changes.

The company said it plans to initiate a Phase 3 program in Q4 2026.

Edgewise Therapeutics shares were down more than 24% in premarket activity Tuesday.

Price: $26.50, Change: $-8.71, Percent Change: -24.74%

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