Clemidsogene lanparvovec (RGX-121) PDUFA Date (REGENXBIO)
FDA PDUFA decision date for Clemidsogene lanparvovec (RGX-121) is February 8, 2026. Developed by REGENXBIO. Indication: Mucopolysaccharidosis type II (Hunter syndrome). Current status: CRL.
Indication
Mucopolysaccharidosis type II (Hunter syndrome)
Regulatory details
- Company: REGENXBIO
- Therapeutic area: Rare Disease / Gene Therapy
- Application type: BLA
- Review type: Priority
- PDUFA date: 2026-02-08
- Outcome: CRL