Scholar Rock resubmits apitegromab MAA to EMA for SMA treatment

• Scholar Rock resubmitted its EMA marketing authorization application for apitegromab to treat children and adults with spinal muscular atrophy.
• Filing swaps in an alternate fill-finish site, replacing Catalent Indiana, which prompted withdrawal of the prior MAA over GMP compliance.
• CHMP opinion is expected in H1 2027.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Scholar Rock Holding Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 202610080800BIZWIRE_USPR_____20261008_BW025279) on October 08, 2026, and is solely responsible for the information contained therein.