UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure
On March 14, 2024, Madrigal Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) has granted accelerated approval of Rezdiffra™ (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (“NASH”) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. In addition, the Company posted to its website a corporate presentation in connection with the approval. A copy of the corporate presentation is attached hereto as Exhibit 99.2.
The information in Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 hereto, is being furnished pursuant to Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this item of this report.
Item 8.01 Other Events
On March 14, 2024, the Company announced that the FDA has granted accelerated approval of Rezdiffra™ (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.
Item 9.01. Financial Statements and Exhibits.
(d) The following exhibits are filed as part of this report:
| Exhibit Number |
Description | |
| 99.1 | Press Release of Madrigal Pharmaceuticals, Inc. (March 14, 2024) | |
| 99.2 | Corporate Presentation of Madrigal Pharmaceuticals, Inc. (March 14, 2024) | |
| 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 thereunto duly authorized.
| MADRIGAL PHARMACEUTICALS, INC. | ||||||
| By: | /s/ Mardi Dier | |||||
| Name: | Mardi Dier | |||||
| Title: | Senior Vice President and Chief Financial Officer | |||||
| Date: March 14, 2024 | ||||||