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Tag: fda

Gene TherapyDeveloping

FDA Reopened a Path for a One-Time Hunter Syndrome Gene Therapy

Regenxbio says FDA no longer requires additional studies before reviewing Navsunli/RGX-121 for accelerated approval, a potentially important rare-disease regulatory signal.

Why now

FDA has reopened a filing path after the program’s regulatory outlook had narrowed.

Overclaim risk: high
Primary source: Company
Published: Jun 24, 2026

Regulatory ShiftDeveloping

The FDA May Be Opening a More Flexible Path for Rare-Disease Gene Therapies

A new FDA draft guidance and a series of recent reversals suggest the biggest bottleneck in gene therapy may no longer be the science alone. It may be the approval process itself.

Why now

Draft guidance and recent reversals suggest the rare-disease rulebook is changing in real time.

Overclaim risk: medium-high
Primary source: Regulatory
Published: Jun 24, 2026