Morningstar

Scholar Rock Gets FDA Approval of Isembyld for Spinal Muscular Atrophy

Provided by Dow Jones

By Josh Beckerman 




  Scholar Rock said the Food and Drug Administration approved Isembyld, or apitegromab, for the treatment of spinal muscular atrophy. 



  The drug was approved for adults and for children two years of age and older who are currently receiving a survival motor neuron 2-targeted treatment. 



  Scholar Rock said Friday that Isembyld will be available to ship in the coming days. 



  The company said it was awarded a Rare Pediatric Disease Priority Review Voucher, which may be used to obtain priority review for a future marketing application. 



  In August, Scholar Rock said that under FDA guidance, it successfully removed Catalent Indiana as a commercial fill-finish facility and that the FDA review was progressing well with an alternate fill-finish facility. At the time, Scholar Rock said it was prepared for a launch immediately upon FDA approval. 



  Scholar Rock shares were halted after hours for pending news. 





  Write to Josh Beckerman at josh.beckerman@wsj.com 





  (END) Dow Jones Newswires



  September 11, 2026 19:02 ET (23:02 GMT)


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