Scholar Rock 8-K更正：apitegromab获批后FDA仍要求妊娠安全性研究与骨折警戒报告，属例行上市后承诺而非新限制

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 15, 2026
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 14, 2026, Scholar Rock Holding Corporation (the
“Company”) hosted a live audio webcast (the “Investor Call”) announcing that the U.S. Food and Drug
Administration (“FDA”) has approved ISEMBYLD™ (apitegromab-mstn) for the treatment of spinal muscular atrophy in
adults and children 2 years of age and older who are currently receiving a survival motor neuron 2 (SMN2)-targeted treatment. During
the “questions and answers” portion of the Investor Call, the Company’s management stated in error that the FDA
did not require any post-marketing safety commitments regarding bone or reproductive safety of ISEMBYLD. In connection with its
approval of ISEMBYLD, the FDA outlined a post-marketing requirement that the Company establish a pregnancy safety study to collect
and analyze information on pregnancy complications and birth outcomes for exposed pregnancies. Separately, the FDA also requested
that the Company submit all serious and non-serious domestic and/or foreign cases of fractures as 15-day “alert
reports.” The Company intends to conduct this study and submit any such reports in compliance with the FDA’s
request.
The information in Item 7.01 of this Form 8-K 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.
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 15, 2026
By:
/s/ Junlin Ho
Junlin Ho
General Counsel & Corporate Secretary