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- FDA places hold on REGENXBIO's Hunter syndrome gene therapy after spinal nodules found, company pauses resubmissionThe FDA placed a clinical hold on RGX-121, REGENXBIO's gene therapy for Hunter syndrome, after MRI scans showed small nodules or cystic masses in the spines of five trial participants. The finding…
- FDA places clinical hold on Regenxbio’s RGX-121 gene therapy after spine MRI findings, delaying refiling plansThe U.S. Food and Drug Administration has issued a clinical hold on Regenxbio’s gene therapy candidate RGX-121 after routine MRI scans revealed asymptomatic changes in the spines of trial participa…Fierce Biotech · 4d agoRegulatoryNegative