REGENXBIO Announces Regulatory Update on RGX-121 for MPS II

The FDA has placed a clinical hold on REGENXBIO's gene therapy RGX-121 for Hunter Syndrome due to asymptomatic spine MRI findings in five trial participants, delaying the resubmission of the therapy's Biologics License Application. REGENXBIO is focusing on other gene therapy candidates with different delivery mechanisms while evaluating additional data and FDA feedback for RGX-121's next steps.

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