Scholar Rock Holding Corporation filed a Form 8-K on September 15, 2026, under Regulation FD to correct an erroneous statement made by management during an investor call regarding FDA post-marketing safety commitments for ISEMBYLD (apitegromab-mstn).

Key Highlights

  • FDA approval confirmed: The FDA 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 an SMN2-targeted treatment.
  • Erroneous statement: During the September 14, 2026 investor call, management stated in error that the FDA did not require any post-marketing safety commitments regarding bone or reproductive safety of ISEMBYLD.
  • Pregnancy safety study required: 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.
  • Fracture reporting required: 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."
  • Company commitment: Scholar Rock stated it intends to conduct the required study and submit any such reports in compliance with the FDA's request.

Scholar Rock Clarifies ISEMBYLD Post-Marketing Obligations After Investor Call Error

According to the filing, Scholar Rock Holding Corporation (NASDAQ:SRRK) hosted a live audio webcast on September 14, 2026, to announce FDA approval of ISEMBYLD (apitegromab-mstn) for 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 question-and-answer portion of that investor call, the company disclosed that management "stated in error that the FDA did not require any post-marketing safety commitments regarding bone or reproductive safety of ISEMBYLD."

The filing clarifies two specific post-marketing obligations. First, 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. Second, the FDA requested that the company submit all serious and non-serious domestic and/or foreign cases of fractures as 15-day "alert reports." The company disclosed that it intends to conduct the study and submit any such reports in compliance with the FDA's request.

The Form 8-K was filed under Item 7.01 (Regulation FD Disclosure) and signed by Junlin Ho, General Counsel and Corporate Secretary, on September 15, 2026. The filing notes that the information in Item 7.01 "shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934."

What Was Disclosed

Scholar Rock filed this 8-K to correct a management error made during a September 14, 2026 investor call, specifying two FDA post-marketing obligations tied to ISEMBYLD's approval: a pregnancy safety study and submission of fracture cases as 15-day alert reports.