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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…
- Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findingsThe FDA has put a clinical hold on Regenxbio’s RGX-121 over asymptomatic spine MRI findings, derailing the biotech’s plans to refile for approval of the once-rejected gene therapy candidate.Fierce Biotech · 7h ago↗ source