Scholar Rock sees third-party facility ready for reinspection by end of year

Scholar Rock (SRRK) said Thursday that it had a Type A meeting with the U.S. FDA. The meeting was held in person and was constructive. Catalent Indiana, part of Novo Nordisk (NVO), joined Scholar Rock at the meeting and detailed the progress it has made in implementing the remediation plan, and affirmed that it expects the facility to be ready for reinspection by the end of this year, the company said. Resubmission of the BLA and U.S. launch following approval of apitegromab for children and adults with SMA is anticipated in 2026.