{"id":792894,"date":"2024-12-05T14:35:08","date_gmt":"2024-12-05T19:35:08","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/edgewise-provides-statement-regarding-companys-relationship-with-dr-han-phan-at-rare-disease-research\/"},"modified":"2024-12-05T14:35:08","modified_gmt":"2024-12-05T19:35:08","slug":"edgewise-provides-statement-regarding-companys-relationship-with-dr-han-phan-at-rare-disease-research","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/edgewise-provides-statement-regarding-companys-relationship-with-dr-han-phan-at-rare-disease-research\/","title":{"rendered":"Edgewise Provides Statement Regarding Company\u2019s Relationship with Dr. Han Phan at Rare Disease Research"},"content":{"rendered":"

<\/p>\n

Edgewise Provides Statement Regarding Company\u2019s Relationship with Dr. Han Phan at Rare Disease Research<\/b><\/p>\n

BOULDER, Colo.–(BUSINESS WIRE<\/a>)–
\nEdgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today provided information regarding the company\u2019s relationship with Dr. Han Phan at Rare Disease Research.<\/p>\n

\nOn 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\u2019s warning letter.<\/p>\n

\nEdgewise has audited Dr. Phan\u2019s 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.<\/p>\n

About Edgewise Therapeutics<\/b><\/p>\n

\nEdgewise Therapeutics is a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions. The Company\u2019s 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<\/a> or follow us on LinkedIn<\/a>, X<\/a>, Facebook<\/a> and Instagram<\/a>.<\/p>\n

Cautionary Note<\/b><\/p>\n

\nEdgewise\u2019s 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\u2019s compliance with FDA requirements.<\/p>\n

\nThis 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\u2019s compliance with FDA requirements and the impact of the FDA\u2019s warning letter on Edgewise. Words such as \u201cbelieve\u201d and \u201cexpects\u201d and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon Edgewise\u2019s 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\u2019s clinical activities as a result of the FDA\u2019s actions related to Dr. Han Phan; risks related to the regulatory approval processes being lengthier and more challenging as a result of the FDA\u2019s actions related to Dr. Han Phan; risks associated with the operations of Edgewise\u2019s clinical sites and Edgewise\u2019s advancement of its clinical trials as a result of the FDA\u2019s 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\u2019s actions related to Dr. Han Phan.<\/p>\n

\nInformation regarding the foregoing and additional risks may be found in the section titled \u201cRisk Factors\u201d 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 .<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20241205281873\/en\/<\/a><\/span><\/p>\n

Edgewise Contacts
\n<\/b>
Investors:
\n<\/b>
Behrad Derakhshan, Ph.D., Chief Business Officer
\n
ir@edgewisetx.com<\/a><\/p>\n

Media:
\n<\/b>
Maureen Franco, VP Corporate Communications
\n
media@edgewisetx.com<\/a><\/p>\n

KEYWORDS:<\/b> Colorado United States North America<\/p>\n

INDUSTRY KEYWORDS:<\/b> Research FDA Clinical Trials Cardiology Biotechnology General Health Pharmaceutical Health Science Other Science<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
\"Logo\"<\/td>\n<\/tr>\n
<\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Edgewise Provides Statement Regarding Company\u2019s Relationship with Dr. Han Phan at Rare Disease Research BOULDER, Colo.–(BUSINESS WIRE)– Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today provided information regarding the company\u2019s 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\u2019s warning letter. Edgewise has audited Dr. Phan\u2019s site multiple times and believes that the data related to the Edgewise clinical trials at … <\/p>\n

Continue reading “Edgewise Provides Statement Regarding Company\u2019s Relationship with Dr. Han Phan at Rare Disease Research”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-792894","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nEdgewise Provides Statement Regarding Company\u2019s Relationship with Dr. Han Phan at Rare Disease Research - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/edgewise-provides-statement-regarding-companys-relationship-with-dr-han-phan-at-rare-disease-research\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Edgewise Provides Statement Regarding Company\u2019s Relationship with Dr. Han Phan at Rare Disease Research - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Edgewise Provides Statement Regarding Company\u2019s Relationship with Dr. Han Phan at Rare Disease Research BOULDER, Colo.–(BUSINESS WIRE)– Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today provided information regarding the company\u2019s 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\u2019s warning letter. 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