FDA拒绝批准先导药物，学者洛克股价下跌

2025-09-23 19:45

Scholar Rock (NASDAQ:SRRK) shares fell ~15% in the premarket on Tuesday after the biotech said that the U.S. FDA has issued a Complete Response Letter (CRL) in connection with its marketing application for its lead drug, apitegromab, declining its availability in the U.S.
The company submitted a Biologics License Application with the FDA early this year to obtain the agency’s approval for apitegromab to treat spinal muscular atrophy, a rare neuromuscular disease.
Sending a CRL, the agency has rejected the BLA, citing findings its investigators noticed during a visit to a third-party fill-finish facility in Indiana that Danish drugmaker Novo Nordisk (NVO) acquired in December.
The CRL didn’t indicate any other approvability issues related to the drug, the Cambridge, Massachusetts-based biotech said, adding that it will resubmit the BLA once Catalent Indiana resolves the FDA observations.

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