
FDA Accepts REGENXBIO’s Application for Priority Review of Gene Therapy for Hunter Syndrome (MPS II)
ROCKVILLE, Md., May 13, 2025 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) seeking accelerated approval for clemidsogene lanparvovec (RGX-121) for the treatment of Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome.
The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of November 9, 2025.