Edgewise Therapeutics rises after Cytokinetics succeeds in HCM trial

Shares of Edgewise Therapeutics (EWTX) are up greater than 25% after another drugmaker exploring the same space reported success in a clinical trial. Shares of Cytokinetics (CYTK) are sharply higher in midday trading after the company announced topline results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy, or HCM, a condition that makes it hard for the heart to pump blood. “The results from SEQUOIA-HCM meet our high expectations for both efficacy and safety, demonstrating that aficamten added to standard of care therapy had a positive impact on exercise capacity as well as rapid and sustained effects on symptoms and functional class in patients with obstructive HCM while maintaining the safety and tolerability that we have previously observed. We believe these results are consistent with those observed in REDWOOD-HCM, the Phase 2 clinical trial of aficamten, and FOREST-HCM, the ongoing open label extension clinical trial, and may reflect a profile enabling of aficamten to become the cardiac myosin inhibitor of choice among physicians and patients,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. In mid-September, Edgewise Therapeutics announced initial dosing in a Phase 1 trial of EDG-7500, an oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM and other diseases of diastolic dysfunction. The Phase 1 trial will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of EDG-7500 in healthy adults. The company is also planning to begin a Phase 1b study of EDG-7500 in individuals with obstructive HCM in the first half of 2024. Near 1:30 pm ET, Edgewise shares have gained $2.48, or 26%, to $12.00, while Cytokinetics shares have jumped $35.97, or nearly 79%, to $81.68.