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Scholar Rock's Global Regulatory Path Further De-Risked, Wedbush Says

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Scholar Rock's (SRRK) latest update further de-risks the global apitegromab regulatory path, given the potential approval in the US and clear view on the Japan registration path, offsetting a delay in Europe, Wedbush said Friday.

Earlier, Scholar Rock confirmed removal of Novo Nordisk's (NVO) Catalent Indiana as a commercial fill-finish facility from its US biologics license application, and it expects an approval decision from the US Food and Drug Administration by Sept. 30 for apitegromab as a treatment for spinal muscular atrophy.

In Europe, Scholar Rock said it withdrew its marketing authorization application following the Catalent inspection issue and plans to resubmit with the new facility. In Japan, no additional clinical studies are needed, allowing a new drug application filing by year-end.

Wedbush reiterated its outperform rating on Scholar Rock's stock and raised its price target to $64 from $58.

Price: $56.16, Change: $+0.91, Percent Change: +1.64%

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