Scholar Rock shares suffer on manufacturing site woes
Shares in US biopharma Scholar Rock (Nasdaq: SRRK) closed 13% lower Monday after bad news on its spinal muscular atrophy (SMA) treatment apitegromab.
Scholar Rock received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) last month in relation to apitegromab, citing issues related to previous observations at a fill-finish third-party manufacturing plant.
The company had hoped that these matters would be resolved swiftly at the Catalent Indiana facility - now owned by Danish pharma major Novo Nordisk (NOV: N).
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