UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01 Other Events.
U.S. Food and Drug Administration Authorization for Phase 2 Clinical Trial of EDG-5506 for the Treatment of Duchenne Muscular Dystrophy
On September 7, 2022, Edgewise Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has authorized a clinical trial of EDG-5506 in children with Duchenne muscular dystrophy. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
4-Month Interim Results from the ARCH Open Label Study of EDG-5506 in Adults with Becker Muscular Dystrophy
On September 11, 2022, the Company issued a press release announcing 4-month interim results from the ongoing ARCH study, an open label, single-center study assessing the safety, tolerability, impact on muscle damage biomarkers, and pharmacokinetics of EDG-5506 in adults with Becker muscular dystrophy. A copy of the press release is attached hereto as Exhibit 99.2 and incorporated herein by reference.
Updated Risk Factor Disclosure
The Company is supplementing and updating its risk factors from the disclosure contained under the heading “Item 1A. Risk Factors,” in the Company’s most recent Quarter Report on Form 10-Q for the quarter ended June 30, 2022 and filed with the Securities and Exchange Commission on August 4, 2022. The updated risk factor disclosure is filed herewith as Exhibit 99.3 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
| 99.1 | Press Release, dated September 7, 2022 |
| 99.2 | Press Release, dated September 11, 2022 |
| 99.3 | Updated Risk Factor Disclosure |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| EDGEWISE THERAPEUTICS, INC. | ||
| By: | /s/ Kevin Koch | |
| Kevin Koch, Ph.D. | ||
| President and Chief Executive Officer | ||
Date: September 13, 2022