Edgewise Soars 22% on Promising Heart Drug Safety Data
Phase 2 results for its hypertrophic cardiomyopathy drug show a key safety advantage over a recently approved competitor, boosting investor confidence.
Shares of Edgewise Therapeutics (NASDAQ: EWTX) surged nearly 22% on Wednesday after the biotechnology firm announced positive clinical trial results for its experimental heart disease drug, EDG-7500. The data suggests a potentially superior safety profile compared to existing treatments for hypertrophic cardiomyopathy (HCM), a genetic condition that causes the heart muscle to thicken.
The company's stock jumped $4.74 to close at $26.485, lifting its market capitalization to approximately $2.7 billion. The rally was fueled by interim data from the Phase 2 CIRRUS-HCM trial, which showed the drug was well-tolerated and, critically, did not cause any clinically meaningful reductions in left ventricular ejection fraction (LVEF) — a key measure of the heart's pumping ability.
This safety finding is a significant differentiator in the HCM treatment landscape. Just last week, Cytokinetics received FDA approval for its HCM drug, Aficamten. However, Aficamten carries a boxed warning, the FDA's most stringent, for the risk of heart failure caused by a reduction in LVEF. According to its label, initiation of the drug is not recommended for patients with an LVEF below 55%.
In its latest announcement, Edgewise reported that across all study participants to date, no one treated with EDG-7500 has experienced an LVEF reduction to below 50%. The ongoing Part D of the study, which has been monitoring patients for over 2,600 days, also showed no instances of clinically detectable atrial fibrillation or flutter.
"I'm especially pleased with EDG-7500's safety profile to date, and the lack of clinically relevant drops in ejection fraction, or any ejection fraction drops below 50%," said Kevin Koch, Ph.D., President and CEO of Edgewise Therapeutics. The results position EDG-7500 as a potential best-in-class therapy that could avoid the safety liabilities that may limit the use of current cardiac myosin inhibitors.
Beyond its reassuring safety profile, the trial also showed clear signs of clinical activity. Patients treated with EDG-7500 showed improvements in the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, a key metric for quality of life, as well as improvements in other disease markers. The company noted the KCCQ score improvements were favorable compared to other cardiovascular trials.
Wall Street has taken note of the company's progress, with analysts holding a consensus price target of $38.17 on the stock, implying significant upside from current levels. Of the analysts covering the stock, 10 rate it as a 'Buy' or 'Strong Buy'.
Edgewise is now focused on the path to commercialization. The company exceeded its year-end enrollment goal for the trial, and Dr. Koch highlighted "continued enthusiasm for the program from patients and physicians." Edgewise expects to report comprehensive efficacy and safety data from the full cohort in the second quarter of 2026 and is preparing to initiate pivotal Phase 3 trials by the end of that year, a final step before a potential submission for regulatory approval.