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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (Date of earliest event Reported): September 23, 2025
Scholar Rock Holding Corporation
(Exact Name of Registrant as Specified in Charter)
| Delaware |
001-38501 |
82-3750435 |
(State or Other Jurisdiction of
Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
| |
|
|
| 301 Binney Street, 3rd Floor, Cambridge, MA 02142 |
| (Address of Principal Executive Offices) (Zip Code) |
(857) 259-3860
(Registrant's telephone
number, including area code)
(Former name or
former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title
of each class |
Trading
Symbol(s) |
Name of each exchange
on which registered |
| Common Stock, par value $0.001 per share |
SRRK |
The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17
CFR §240.12b-2). Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected
not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ¨
Item 7.01. Regulation FD Disclosure.
On September 23, 2025, Scholar Rock Holding Corporation (the “Company”)
issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter
(“CRL”) regarding the Biologics License Application (“BLA”) for apitegromab for the treatment of spinal muscular
atrophy (“SMA”). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated
herein by reference.
The information in Item 7.01 of this Form 8-K, including 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 liabilities of that section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01. Other Events.
On September 23, 2025, the Company announced that the FDA has issued
a CRL regarding the BLA for apitegromab for the treatment of SMA.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release issued by the
Company on September 23, 2025, furnished hereto. |
| 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: September 23, 2025 |
By: |
/s/ Junlin Ho |
| |
|
Junlin Ho |
| |
|
General Counsel & Corporate Secretary |
