Edgewise reports promising HCM trial results for EDG-7500

Published 02/04/2025, 11:06
Edgewise reports promising HCM trial results for EDG-7500

BOULDER, Colo. - Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a biopharmaceutical company focused on muscle diseases with a market capitalization of $1.9 billion, today announced positive results from the Phase 2 trial of its drug candidate EDG-7500 for treating hypertrophic cardiomyopathy (HCM), a genetic heart condition. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, positioning it well for continued clinical development.

The four-week CIRRUS-HCM trial demonstrated that EDG-7500, an oral cardiac sarcomere modulator, led to significant reductions in left ventricular outflow tract gradients in patients with obstructive HCM. The drug also showed improvements in cardiac biomarkers and diastolic function without affecting systolic function, as no participant’s left ventricular ejection fraction (LVEF) dropped below 50%. With a current ratio of 19.9x, InvestingPro analysis shows the company has ample liquidity to support its clinical programs, though it’s worth noting the company is not yet profitable.

In the trial’s two parts, 17 participants with obstructive HCM and 12 with nonobstructive HCM received daily doses of either 50 or 100 mg of EDG-7500. Those on the higher dose experienced substantial improvements in heart failure biomarkers and reported better quality of life based on the Kansas City Cardiomyopathy Questionnaire. Additionally, 78% of participants improved by at least one New York Heart Association (NYHA) functional class, with 67% reaching Class I, indicating asymptomatic status.

Adverse events reported were mostly mild to moderate, including dizziness, respiratory infections, and atrial fibrillation. Two serious events of atrial fibrillation required cardioversion, aligning with rates from other HCM Phase 2 trials.

Comments from Dr. Ahmad Masri and Dr. Anjali T. Owens, both investigators in the trial, highlighted the encouraging changes in multiple domains, including diastolic function and symptom relief, reinforcing the potential of EDG-7500 as an important investigational therapy.

Kevin Koch, Ph.D., President and CEO of Edgewise, expressed optimism for the drug’s advancement into Phase 3, emphasizing its potential benefit for HCM patients without causing systolic dysfunction. The company plans to initiate Phase 3 in the first half of 2026, following further optimization in Part D of the ongoing trial.

This report is based on a press release statement from Edgewise Therapeutics. Investors looking ahead should note that the company’s next earnings report is scheduled for May 8, 2025. For deeper insights into EWTX’s financial health and growth prospects, including additional ProTips and comprehensive analysis, check out the detailed research report available on InvestingPro.

In other recent news, Edgewise Therapeutics has drawn attention with several key developments. The company is preparing for the release of Phase 2 data for its drug candidate EDG-7500, which targets hypertrophic cardiomyopathy (HCM). Analysts from Truist Securities and Piper Sandler have maintained positive outlooks, with Truist setting a $50 price target and Piper Sandler placing it at $51. Both firms emphasize the significance of the upcoming data, expected by the end of March 2025, which will evaluate the drug’s efficacy and safety. Scotiabank has also initiated coverage with a Sector Outperform rating and a $50 target, citing the potential for Edgewise’s drug candidates to achieve multi-billion-dollar sales.

Additionally, JPMorgan has raised its price target for Edgewise Therapeutics to $45, maintaining an Overweight rating due to optimism about the company’s diversified approach to neuromuscular and cardiovascular conditions. The firm is particularly focused on the 28-day portion of the ongoing Phase 2 CIRRUS-HCM study. In corporate news, Edgewise Therapeutics announced the promotion of Behrad Derakhshan, Ph.D., to Chief Operating Officer, effective January 2025. Dr. Derakhshan has been with the company since 2020 and brings extensive experience from previous leadership roles in the biotech industry. This leadership transition is part of Edgewise’s strategy to bolster its executive team as it advances its pipeline of therapies for rare diseases.

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