Regulation FD Disclosure (Form 8-K)

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.