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.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.