Scholar Rock resubmits apitegromab BLA to FDA for spinal muscular atrophy treatment

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  • Scholar Rock resubmitted Biologics License Application to FDA for apitegromab to treat children and adults with spinal muscular atrophy.
  • Filing adds Catalent Indiana, now part of Novo Nordisk, plus a second U.S. fill-finish site to support supply.
  • FDA acceptance expected within 30 days; PDUFA action date expected in late September 2026.
  • EMA review of apitegromab marketing application continues; decision expected mid-2026.


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 via Business Wire (Ref. ID: 202603310700BIZWIRE_USPR_____20260331_BW950583) on March 31, 2026, and is solely responsible for the information contained therein.

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