Scholar Rock Resubmits Marketing Authorisation Application For Apitegromab

(RTTNews) - Scholar Rock (SRRK) has resubmitted the Marketing Authorisation Application for apitegromab for the treatment of children and adults with spinal muscular atrophy to the European Medicines Agency. The resubmitted apitegromab MAA includes Scholar Rock's alternate fill-finish facility in place of the Catalent Indiana fill-finish facility.

In August 2026, Scholar Rock informed the Committee for Medicinal Products for Human Use of the withdrawal of its previous MAA due to a lack of GMP compliance at the Catalent Indiana fill-finish facility. With the MAA resubmission, the company anticipates a CHMP opinion in the first half of 2027.

In pre-market trading on NasdaqGS, Scholar Rock shares are down 0.47 percent to $42.00.

For More Such Health News, visit rttnews.com.