By Denny Jacob
Scholar Rock's biologics license application for apitegromab was accepted by the Food and Drug Administration.
The late-stage biopharmaceutical company said the regulator will review the application under priority review and has assigned a Prescription Drug User Fee Act target action date of Sept. 22.
Apitegromab is an investigational treatment aimed at improving motor function for people living with spinal muscular atrophy.
Scholar Rock said it has also submitted and received validation for its marketing authorization application to the European Medicines Agency for apitegromab to treat SMA.
The Cambridge, Mass., company is planning for a U.S. commercial launch upon approval in 2025, with European launch expected in 2026, in anticipation of potential regulatory approvals.
Shares ticked up 3.5% to $34.99 in premarket trading. The stock has more than doubled over the last year.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
March 25, 2025 08:44 ET (12:44 GMT)
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