News & Events zu Scholar Rock Holding Corp (SRRK)SRRKScholar Rock Holding Corp

Intellia Therapeutics Appoints Jing Marantz as Chief Medical Officer

Intellia Therapeutics (NTLA) announced the appointment of Jing Marantz as executive VP and chief medical officer, effective October 26. Marantz will lead the company's translational, development, regulatory and medical affairs functions. recently, she served as chief medical officer for Scholar Rock (SRRK).

Scholar Rock Resubmits Marketing Authorization Application for Apitegromab

Scholar Rock announced it has resubmitted the Marketing Authorisation Application, MAA, for apitegromab for the treatment of children and adults with spinal muscular atrophy, SMA, to the European Medicines Agency, EMA. Informed by ongoing dialogue with the EMA, the resubmitted apitegromab MAA includes Scholar Rock's alternate fill-finish facility in place of the Catalent Indiana fill-finish facility. The alternate fill-finish facility is the same site that supported the U.S. FDA approval of ISEMBYLD in September 2026.

Scholar Rock's Isembyld Approved by FDA, Requires Pregnancy Safety Study

Scholar Rock disclosed earlier today on a live audio webcast yesterday announcing the Food and Drug Administration has approved Isembyld, 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, Scholar Rock said today. 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. Shares of Scholar Rock are down 4% to $49.97 in late day trading.