REGENXBIO Inc. announced on May 13, 2025, that the U.S. Food and Drug Administration (FDA) accepted for review its Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121) for the treatment of Mucopolysaccharidosis II (MPS II).
The FDA granted the BLA Priority Review, setting a Prescription Drug User Fee Act (PDUFA) target action date of November 9, 2025. This accelerated pathway is for serious conditions where the drug could provide significant improvements in safety or effectiveness.
REGENXBIO retains all rights to, and 100 percent of any proceeds related to the potential sale of, the Priority Review Voucher (PRV) that could be received upon approval of RGX-121. This represents a significant potential non-dilutive asset for the company.
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