Scholar Rock announces press release on apitegromab CHMP opinion timing for SMA MAA - SRRK News | RalliesScholar Rock announces press release on apitegromab CHMP opinion timing for SMA MAA
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SRRK• Scholar Rock flags potential delay for EMA CHMP opinion
- Scholar Rock flagged a delay risk for an EMA CHMP opinion on apitegromab’s MAA in spinal muscular atrophy.
- Timing hinges on the FDA’s inspection classification for Catalent Indiana’s fill-finish site following an April 2026 inspection.
- If reclassified, the CHMP opinion is expected later in 2026; otherwise the MAA may shift to a second fill-finish facility.
- U.S. BLA review continues with a Sept. 30, 2026 PDUFA action date.
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