Regenxbio Hits Regulatory Roadblock After FDA Puts RGX-121 on Hold

The FDA has placed a clinical hold on Regenxbio's gene therapy RGX-121 for Hunter Syndrome following asymptomatic spine MRI findings in five trial participants. The company does not expect to resubmit the therapy's Biologics License Application soon and will continue patient monitoring while engaging with the FDA for next steps.

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