- Advancing robust clinical pipeline of novel therapeutics for muscular dystrophies and serious cardiac conditions -
- Presenting at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026 at 8:15 am PT (11:15 am ET) -
BOULDER, Colo., Jan. 13, 2026 /PRNewswire/ -- Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today provided updates on the Company's clinical programs and highlighted major milestones for 2026. Edgewise Chief Executive Officer, Kevin Koch, Ph.D., will present these updates today at the J.P. Morgan 2026 Healthcare Conference.
"2025 marked a year of disciplined execution and substantial advances in our skeletal and cardiovascular programs, supported by a strong balance sheet," said Dr. Koch. "Entering 2026, our Company is poised for a transformative year. With full enrollment in our pivotal GRAND CANYON cohort, we remain on track for top-line data that could help establish sevasemten as the first approved therapy in Becker muscular dystrophy (Becker), potentially altering the course of this devastating disease. In parallel, we anticipate Phase 2 results for EDG-7500 in hypertrophic cardiomyopathy (HCM) in the first half of the year, that will enable us to finalize designs for our Phase 3 program in obstructive and nonobstructive HCM. Backed by multiple near-term catalysts and an exceptional team committed to excellence, we are closer than ever to bringing transformative medicines to patients who urgently need them."
2026 Priorities
Sevasemten
- Complete the GRAND CANYON global pivotal cohort and announce top-line results in individuals with Becker in the fourth quarter of 2026.
- Prepare for submission of a New Drug Application with the U.S. Food and Drug Administration for sevasemten in Becker in the first half of 2027.
- Finalize the design and plan for a Phase 3 trial in individuals with Duchenne muscular dystrophy (Duchenne) in the second half of 2026.
EDG-7500
- Report CIRRUS-HCM 12-week data in individuals with obstructive and nonobstructive HCM in the first half of 2026.
- Initiate a Phase 3 trial in individuals with obstructive and nonobstructive HCM in the second half of 2026.
EDG-15400
- Report Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose data of EDG-15400 in healthy adults in the first half of 2026.
- Initiate Phase 2 trial in participants with heart failure with preserved ejection fraction with results anticipated in the first half of 2027.
2025 Accomplishments
Financial
- Strengthened balance sheet with net proceeds of approximately $200 million from April 2025 public follow-on offering supporting our muscular dystrophy and cardiovascular programs.
Sevasemten
- Completed enrollment of GRAND CANYON in adults with Becker.
- Reported positive top-line data from the MESA Phase 2 open label extension trial in adults with Becker.
- Reported encouraging observations from the LYNX Phase 2 placebo-controlled trial in participants with Duchenne across functional measures, including Stride Velocity 95th Centile (SV95C), North Star Ambulatory Assessment (NSAA) and 4 stair-climb, while identifying a dose of 10 mg to evaluate in Phase 3.
- Reported initial results from the FOX Phase 2 placebo-controlled trial in participants with Duchenne previously treated with gene therapy that also supported that sevasemten 10 mg has the potential to reduce the rate of functional decline.
EDG-7500
- Announced completion of CIRRUS-HCM Phase 2 Parts B and C.
- Initiated the CIRRUS-HCM Part D 12-week study in obstructive HCM or nonobstructive HCM; delivered a favorable interim safety update in December 2025.
EDG-15400
- Initiated the Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose trial of EDG-15400 in healthy adults.
J.P. Morgan Healthcare Conference Presentation and Webcast
Edgewise management will highlight these updates in a corporate presentation today at the J.P. Morgan Healthcare Conference at 8:15 am PT (11:15 am ET). The presentation will be webcast live; a link for the webcast can be found on the Edgewise Events & Presentations page and will be accessible for replay, for a limited time, following the conference. It is recommended that users connect to the live webcast several minutes prior to the start to ensure a timely connection.
About Edgewise Therapeutics
Edgewise Therapeutics is a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions. The Company's deep expertise in muscle physiology is driving a new generation of novel therapeutics. Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor in late-stage clinical trials in Becker and Duchenne muscular dystrophies. EDG-7500 is a novel cardiac sarcomere modulator for the treatment of hypertrophic cardiomyopathy, currently in Phase 2 clinical development. EDG-15400 is a novel cardiac sarcomere modulator for the treatment of heart failure, currently in Phase 1 clinical development. The entire team at Edgewise is dedicated to our mission: changing the lives of patients and families affected by serious muscle diseases. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn and X.
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 sevasemten, EDG-7500, EDG-15400 and its cardiovascular program; statements regarding the ability of the Company to establish sevasemten as the first approved therapy in Becker; statements regarding bringing transformative medicines to patients; statements regarding the Company's 2026 priorities; statements regarding Edgewise's expectations relating to its clinical trials, including timing of the completion of the GRAND CANYON trial, finalizing design for the Company's Phase 3 program in obstructive and nonobstructive HCM, timing of reporting data (including top-line data of sevasemten, Phase 2 results for EDG-7500 in HCM, the presentation of data from the GRAND CANYON trial and the presentation of data from the Phase 1 trial of EDG-15400) and timing of initiation of clinical trials (including Phase 3 trials in individuals with HCM and Duchenne and Phase 2 trial of EDG-15400); statements regarding Edgewise's ability to advance its pipeline; statements regarding Edgewise's timing for filing a New Drug Application with the FDA for sevasemten in Becker; and statements by Edgewise's President 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 need for substantial additional capital to finance its operations; Edgewise's substantial dependence on the success of sevasemten and EDG-7500; Edgewise's ability to develop and commercialize sevasemten, EDG-7500 and EDG-15400, and discover, develop and commercialize product candidates in its cardiovascular and future programs; 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 exposure to additional risk if we develop sevasemten and potential other programs in connection with other therapies; 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 patient population for our product candidates having a small patient population; 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 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.
This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.
SOURCE Edgewise Therapeutics
