Page updated ·next FDA decision on the calendar·Data as of Oct 21, 2026 12:50 PM ET
What the sponsor said about the review
Scholar Rock Holding Corporation, in its own words: “Scholar Rock will continue to collaborate closely with the FDA and under their guidance, will remove Catalent Indiana from the apitegromab BLA. FDA review of the apitegromab BLA will progress solely with the second fill-finish facility.” Scholar Rock 8-K 2026-09-14 (EX-99.1).
SRRK has no FDA decision date ahead on the pdufa.bio calendar. 2 past decisions are on record below, each on its own page. One event, one page: past decisions never share a URL with a live catalyst.
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