FDA extends PDUFA date for RGX-121 BLA to February 8, 2026

REGENXBIO Inc.

PDUFA goal date extended from Nov 9, 2025 to Feb 8, 2026 for review of additional 12-month data from pivotal study (n=13).
No safety concerns raised; pre-license inspection completed with no observations.
Company to present updated pivotal data at ICIEM meeting in September 2025; commercial launch plans remain on track.
RGX-121 would be first potential one-time therapy for MPS II (Hunter syndrome); holds FDA Orphan, Rare Pediatric, Fast Track, RMAT designations.

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