The U.S. Food and Drug Administration (FDA) on Monday extended its review timeline for REGENXBIO Inc.'s RGNX Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121) for Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome. The Prescription Drug User Fee Act (PDUFA) goal date has been extended from November 9, 2025, to February 8, 2026. The extension follows the company's submission of longer-term clinical data for all patients in the pivotal study of RGX-121 (n=13) in response ...