Morningstar

Scholar Rock: FDA Turns Away Apitegromab Application

Provided by Dow Jones

By Colin Kellaher 




  Scholar Rock Holding said the Food and Drug Administration has turned away its application seeking approval of apitegromab for the rare genetic neuromuscular disease spinal muscular atrophy due to issues at a contract manufacturer. 



  Scholar Rock on Tuesday said the FDA has issued a so-called complete response letter, indicating the agency won't approve the Cambridge, Mass., biopharmaceutical company's application in its current form. 



  Scholar Rock said the FDA cited observations identified during a routine general site inspection of Catalent Indiana, a third-party fill-finish plant acquired by Novo Nordisk last year. 



  The company said the FDA didn't raise any other approvability concerns, adding that it plans to resubmit its application upon Catalent Indiana's successful remediation of the agency's observations. 



  Trading in shares of Scholar Rock, which closed Monday at $32.58, was halted premarket Tuesday. 





  Write to Colin Kellaher at colin.kellaher@wsj.com 





  (END) Dow Jones Newswires



  September 23, 2025 07:36 ET (11:36 GMT)


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