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Benzinga
Benzinga
Business
Vandana Singh

FDA Extends Decision Date On Regenxbio's Gene Therapy Into Next Year

FDA Regenxbio Gene Therapy
REGENXBIO Inc

The U.S. Food and Drug Administration (FDA) on Monday extended its review timeline for REGENXBIO Inc.’s (NASDAQ: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.

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