Scholar Rock withdraws EU apitegromab filing after FDA flags Catalent Indiana plant with OAI inspection rating

• Scholar Rock removed Catalent Indiana as an apitegromab fill-finish site from its FDA BLA following an OAI inspection classification.
• FDA review continues with an alternate U.S. fill-finish facility; an approval decision is due by the Sept. 30, 2026 PDUFA date.
• In Europe, the apitegromab MAA was withdrawn to remove Catalent Indiana; a resubmission is planned using the alternate site.
• Management expects to be ready to launch in the U.S. upon approval, citing existing commercial vial supply from the alternate facility.
• In Japan, PMDA aligned that no additional clinical studies are needed; a JNDA filing is targeted by year-end 2026.

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: 202608210906BIZWIRE_USPR_____20260821_BW050366) on August 21, 2026, and is solely responsible for the information contained therein.