# REGENXBIO Aligns with FDA on Accelerated Approval Path for Hunter Syndrome Gene Therapy NAVSUNLI

> fda · REPORTED · 2026-06-22

On June 22, 2026, REGENXBIO announced FDA confirmed no additional clinical studies are required, clearing a path to resubmit the NAVSUNLI (RGX-121) BLA for accelerated approval for MPS II (Hunter syndrome) in Q3 2026. The agency will review existing CAMPSIITE study data on an expedited basis, sending shares up 16.3%.

- Company: REGENXBIO
- Sector: biotech
- Primary source: https://ir.regenxbio.com/news-releases/news-release-details/regenxbio-announces-alignment-fda-path-forward-navsunlitm-bla

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.