Scholar Rock Holding Corp (SRRK), a late-stage biopharmaceutical company, on Tuesday said that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its apitegromab for the treatment of patients with spinal muscular atrophy (SMA). Following the news, the company's shares fell more than 12% in pre-market.
The CRL is based on findings from a routine inspection of Catalent Indiana LLC, a third-party manufacturing facility, and not related to the safety or efficacy of apitegromab.
Scholar Rock plans to resubmit the Biologics License Application (BLA) for apitegromab once Catalent Indiana successfully addresses the FDA's observations.
"We are continuing to work closely with Catalent Indiana on the FDA's manufacturing observations so that we can resubmit the apitegromab BLA as soon as possible," said David L. Hallal, Chairman and Chief Executive Officer of Scholar Rock.
Shares of Scholar Rock had closed at $32.58, up 5.64% on Monday. The stock has traded in the range of $6.76 - $46.98 in the last 1 year.
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