Scholar Rock Holding Corp
CRL Confirmed
apitegromab
spinal muscular atrophy
Resolved
280days ago
FDA decision Β· ~ Sep 30, 2025 estimated
What's at stake An FDA complete response letter on apitegromab for spinal muscular atrophy is in focus around ~ Sep 30, 2025.
β€œScholar Rock plans to resubmit the apitegromab BLA following a successful reinspection of the site.”

Provenance

3 sources on file.

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