UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure. |
On October 7, 2024, Scholar Rock Holding Corporation (the “Company”) issued a press release announcing positive topline data from its Phase 3 SAPPHIRE trial evaluating apitegromab, an investigational fully human monoclonal antibody that inhibits myostatin, and plans to submit a U.S. Biologics License Application and European Union marketing authorization application in the first quarter of 2025. A copy of the press release is attached hereto as Exhibit 99.1.
The information in this Item 7.01 of Form 8-K, including the accompanying Exhibit 99.1, 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 liability of such section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing.
| Item 8.01. | Other Events. |
The Company has also made available a slide presentation relating to topline data from its Phase 3 SAPPHIRE trial evaluating apitegromab for the potential treatment of spinal muscular atrophy, a copy of which is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description |
| 99.1 | Press Release issued by the Company on October 7, 2024, furnished herewith. |
| 99.2 | Presentation Slide Deck |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
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.
| Scholar Rock Holding Corporation | ||
| Date: October 7, 2024 | By: | /s/ Junlin Ho |
| Junlin Ho | ||
| General Counsel and Corporate Secretary | ||