Scholar Rock says apitegromab CHMP opinion awaits FDA classification update for Catalent Indiana site
SRRK•CHMP opinion timing depends on FDA classification update
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.
