BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today provided information regarding the company’s relationship with Dr. Han Phan at Rare Disease Research.
On November 27, 2024, the U.S. Food and Drug Administration (FDA) issued a warning letter to Dr. Phan based on a 2024 site inspection related to her work with another company. This warning letter is unrelated to any Edgewise clinical trial or data. None of the Edgewise clinical trials are the subject of the FDA’s warning letter.
Edgewise has audited Dr. Phan’s site multiple times and believes that the data related to the Edgewise clinical trials at the site are being acquired and stored in accordance with FDA requirements.
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 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 and other diseases of diastolic dysfunction, currently in Phase 2 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, X, Facebook and Instagram.
Cautionary Note
Edgewise’s statements are based only on limited and preliminary information and analysis. Additional information or further analysis may arise that could lead to different conclusions regarding Edgewise’s compliance with FDA requirements.
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 Edgewise’s compliance with FDA requirements and the impact of the FDA’s warning letter on Edgewise. Words such as “believe” and “expects” 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 the FDA being more likely to audit Edgewise’s clinical activities as a result of the FDA’s actions related to Dr. Han Phan; risks related to the regulatory approval processes being lengthier and more challenging as a result of the FDA’s actions related to Dr. Han Phan; risks associated with the operations of Edgewise’s clinical sites and Edgewise’s advancement of its clinical trials as a result of the FDA’s actions related to Dr. Han Phan; and risks associated with delays or difficulties in the enrollment and/or maintenance of patients in clinical trials as a result of the FDA’s actions related to Dr. Han Phan.
Information regarding the foregoing and additional risks may be found in the section titled “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 .
