Edgewise Therapeutics Unveils the Differentiated Mechanism of Action (MoA) of its Cardiac Sarcomere Modulator EDG-7500

- The MoA that targets the Regulatory Light Chain (RLC) has shown in preclinical models to improve cardiac relaxation while preserving systolic function and cardiac reserve -

- Company to host webcast to discuss these findings today at 8:30 a.m. Eastern Time -

BOULDER, Colo., Sept. 22, 2026 /PRNewswire/ -- Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading clinical-stage biopharmaceutical company focused on cardiovascular diseases, today announced that it will host an investor conference call to discuss the preclinical pharmacologic profile of EDG-7500, a first-in-class cardiac sarcomere modulator targeting the RLC. Data will be provided supporting EDG-7500's ability to improve cardiac relaxation while preserving overall systolic performance. Furthermore, early clinical observations in patients with symptomatic hypertrophic cardiomyopathy (HCM) have been consistent with these preclinical data. A peer-reviewed publication describing EDG-7500's MoA will be released later today. A link to the article will be available on the Edgewise corporate website once published.

"We screened more than 7,000 pharmacologically diverse RLC candidates and selected molecules that exhibited positive lusitropic properties without systolic liabilities," said Alan Russell, Ph.D., Chief Scientific Officer of Edgewise Therapeutics. "EDG-7500's diastolic-biased profile has the potential to address a central pathologic driver of both symptomatic obstructive and nonobstructive HCM." 

"Today's update highlights the strength of our cardiovascular pipeline and the momentum behind our approach to fine-tune the cardiac cycle in symptomatic heart failure," added Kevin Koch, President and Chief Executive Officer of Edgewise Therapeutics.

Webcast Event

Members of the Edgewise management team will hold a live webcast on Tuesday, September 22, 2026, at 8:30 a.m. ET to discuss the RLC as a unique target for symptomatic heart failure. An accompanying slide presentation will also be available. To register for the live webcast and replay, please visit the Edgewise events page.

About EDG-7500

EDG-7500 is an investigational, oral, first-in-class cardiac sarcomere modulator designed to slow early contraction velocity and improve impaired cardiac relaxation associated with symptomatic HCM. EDG-7500 is being evaluated in obstructive and nonobstructive HCM. The Company completed a 12-week Phase 2 CIRRUS-HCM trial with EDG-7500 which was generally safe and well tolerated and showing no clinically significant changes in left ventricular ejection fraction. Edgewise expects to initiate a Phase 3 trial in the fourth quarter of 2026.

About Hypertrophic Cardiomyopathy

HCM is the most common form of genetic heart disease, affecting approximately one in 500 people, and is associated with reduced quality of life and an elevated risk of heart failure, abnormal heart rhythms, and sudden cardiac death. Individuals with HCM can become extremely limited in their functional capacity and ability to perform the activities of daily living. Commonly experienced symptoms include breathlessness, irregular heartbeat, chest pain, tiredness, dizziness, or even fainting. These symptoms are caused by excessive contraction and thickening (hypertrophy) of the left ventricular wall of the heart. Over time, the thickened muscle becomes stiff, making it difficult for the heart to relax and fill with blood (diastolic dysfunction). There are two major forms of HCM: obstructive and nonobstructive. Despite advancements in treatment options for some patients with HCM, there remains a significant unmet need for additional therapeutic approaches for patients.

About Edgewise Therapeutics                                                              

Edgewise Therapeutics is a cardiometabolic biotechnology company pioneering a new field of medicine centered on restoring cardiac equilibrium—the dynamic balance of the cardiac cycle. Drawing on deep expertise in integrated muscle physiology and small molecule drug development, Edgewise is advancing first-in-class therapies designed to fine-tune cardiac muscle function and redefine the treatment of symptomatic hypertrophic cardiomyopathy and heart failure. To learn more, go to edgewisetx.com or follow Edgewise on LinkedIn, X, Facebook and Instagram.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Statements in this press release that are not purely historical are forward-looking statements.  Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, Edgewise's product candidates and programs, including EDG-7500; statements regarding Edgewise's expectations relating to its clinical trials; statements regarding timing of Edgewise's initiation of a Phase 3 trial of EDG-7500; and statements by Edgewise's Chief Scientific Officer and Chief Executive Officer.  Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements.  The forward-looking statements contained herein are based upon Edgewise's current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with Edgewise's limited operating history, its products being early in development and not having products approved for commercial sale; risks associated with Edgewise not having generated any revenue to date; Edgewise's ability to achieve objectives relating to the discovery, development and commercialization of its product candidates, if approved; Edgewise's potential need for substantial additional capital to finance its operations; Edgewise's substantial dependence on the success of EDG-7500; risks related to Edgewise's clinical trials of its product candidates not demonstrating safety and efficacy; risks related to Edgewise's product candidates causing serious adverse events, toxicities or other undesirable side effects; the outcome of preclinical testing and early clinical trials not being predictive of the success of later clinical trials and the risks related to the results of Edgewise's clinical trials not satisfying the requirements of regulatory authorities; delays or difficulties in the enrollment and/or maintenance of patients in clinical trials; risks related to failure to capitalize on other indications or product candidates; risks related to competition; risks relating to interim, top-line and preliminary data from Edgewise's clinical trials changing as more patient data becomes available; risks related to failure to develop a proprietary drug discovery platform; risks related to production of drugs by Edgewise's third-party manufacturers; risks related to changes in methods of product candidate manufacturing or formulation; risks related to not achieving adequate market acceptance; risks related to the regulatory approval processes of domestic and foreign authorities being lengthy, time consuming and inherently unpredictable; risks relating to disruptions at the FDA, the SEC and other government agencies; risks relating to Edgewise's ability to attract and retain highly skilled executive officers and employees; Edgewise's ability to obtain and maintain intellectual property protection for its product candidates; Edgewise's reliance on third parties; risks related to future acquisitions or strategic partnerships; risks related to Edgewise's future operations following the sale of sevasemten; risks relating to Edgewise not receiving milestone payments related to the Transaction; risks related to general economic and market conditions; and other risks.  Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that Edgewise files from time to time with the U.S. Securities and Exchange Commission.  These forward-looking statements are made as of the date of this press release, and Edgewise assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

SOURCE Edgewise Therapeutics