10:53 AM EDT, 09/23/2025 (MT Newswires) -- Scholar Rock's ( SRRK ) potential treatment for spinal muscular atrophy, apitegromab, will eventually get approved despite the US Food and Drug Administration's complete response letter tied to issues at Catalent's fill-finish facility in Indiana delaying the drug's US launch, Wedbush Securities said in a note Tuesday.
The firm said no concerns were raised by the FDA about the drug's clinical data or safety.
Wedbush said it expects the US launch to be delayed by about a year, while a review in Europe remains active with a decision expected by mid-2026.
Wedbush maintained an outperform rating on the stock and lowered its price target to $43 from $50.
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