Edgewise's stock soars 50% after heart disease drug safety data

Edgewise Therapeutics has made a significant entrance into the hypertrophic cardiomyopathy (HCM) treatment space, as early safety data for its drug candidate, EDG-7500, has significantly boosted the company’s stock. EDG-7500 was tested both in healthy individuals and patients with obstructive HCM, yielding promising results. In healthy subjects, phase 1 trials indicated that the cardiac sarcomere modulator was generally well tolerated. Phase 2 trials focusing on patients with HCM demonstrated notable improvements in several heart health indicators.

A single 200 mg dose of EDG-7500 led to an average 64% reduction in NT-proBNP levels, a crucial biomarker for heart failure, according to the first part of the CIRRUS-HCM phase 2 study. Additionally, Edgewise confirmed that no participants in either trial exhibited a left ventricle ejection fraction (LVEF) below 50%. This is significant since LVEF levels between 50% and 70% are considered normal, while levels below 40% indicate potential heart disease. For HCM patients, EDG-7500 showed substantial reductions in left ventricle outflow tract gradients without significantly altering LVEF, which is a critical measure of the disease’s severity.

Based on these encouraging results, Edgewise has moved forward with the 28-day segment of its CIRRUS-HCM trial, encompassing both obstructive and non-obstructive HCM patients. Marc Semigran, M.D., Chief Development Officer, highlighted this progress in a statement released by the company on September 19. EDG-7500 is designed to decelerate early contraction velocity and address the impaired cardiac relaxation frequently observed in HCM. CEO Kevin Koch, Ph.D., emphasized the innovative approach of achieving gradient relief without reducing LVEF, suggesting it could represent a significant advancement in treating obstructive HCM. The company anticipates releasing initial 28-day data in the first quarter of 2025.

The promising early results have had a positive impact on the company’s stock, which surged by 55% to $29.50 at the close of trading on Thursday. If EDG-7500 successfully reaches the market, it will compete with Bristol Myers Squibb’s Camzyos and Cytokinetics’ aficamten, the latter of which is currently under submission to the FDA.

Despite the promising data from Edgewise, analysts suggest that it is premature to predict how EDG-7500 will affect the market. Analysts at Mizuho Securities acknowledged that while the new data from Edgewise does not provide strong reasons to challenge Cytokinetics’ aficamten, especially given its advanced stage in the approval process, EDG-7500's phase 2 data appears comparable to Cytokinetics’ earlier results. However, they cautioned that making direct comparisons is challenging due to the limited efficacy data currently available for Edgewise’s candidate.