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FDA places clinical hold on Regenxbio's gene therapy for Hunter Syndrome | Reuters

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FDA places clinical hold on Regenxbio gene therapy after MRI abnormalities

The FDA halted testing of Regenxbio's gene therapy for Hunter Syndrome after spinal MRI scans detected abnormalities in five trial participants. This is the second clinical hold placed on a Regenxbio gene therapy program.

Aug 24, 2026·2 sourcesGene therapyFDA regulationsDrug safetyClinical trials
FDA places clinical hold on Regenxbio gene therapy after MRI abnormalities
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BioPharma Dive

Safety concerns spur FDA to again halt testing of Regenxbio gene therapy

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