Scholar Rock says apitegromab CHMP opinion awaits FDA classification update for Catalent Indiana site

SCHOLAR ROCK HOLDING CORP

SCHOLAR ROCK HOLDING CORP

SRRK

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  • Scholar Rock flagged a delay risk for the EMA CHMP opinion on apitegromab for spinal muscular atrophy.
  • Timing hinges on the FDA’s inspection classification for Catalent Indiana’s fill-finish site following an April 2026 inspection.
  • If Catalent Indiana is reclassified, the CHMP opinion is expected later in 2026.
  • If not, the company plans to work with the EMA to proceed using a second fill-finish facility already included in the US BLA.
  • The US FDA review has a Sept. 30, 2026 PDUFA action date; an update is planned for the Aug. 6 earnings call.


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 on July 20, 2026, and is solely responsible for the information contained therein.

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