Scholar Rock Holding Corporation, a late-stage biopharmaceutical company, announced that its Biologics License Application $(BLA.AU)$ for apitegromab, a treatment for spinal muscular atrophy $(SMA)$, has been accepted under priority review by the U.S. Food and Drug Administration (FDA). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of September 22, 2025. Additionally, the European Medicines Agency $(EMA)$ has validated Scholar Rock's Marketing Authorisation Application $(MAA)$ for apitegromab for patients with SMA. This marks a significant step forward for the company in its mission to develop and commercialize treatments for debilitating neuromuscular diseases.
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