Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findings

Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findings — Live Feedhttps://www.live-feeds.com/feed/regenxbio-gene-therapy-refiling-plan-derailed-by-fda-hold-over-spine-mri-findingsContinuously updated, source-cited coverage. FDA holds Regenxbio gene therapy trial over spine MRI findingshttps://www.live-feeds.com/feed/regenxbio-gene-therapy-refiling-plan-derailed-by-fda-hold-over-spine-mri-findingshttps://www.live-feeds.com/feed/regenxbio-gene-therapy-refiling-plan-derailed-by-fda-hold-over-spine-mri-findings#u48679Wed, 26 Aug 2026 03:41:54 +0000The FDA has placed a clinical hold on Regenxbio's gene therapy trial for Hunter syndrome due to asymptomatic spine MRI findings in five participants. This development has derailed the company's plans to resubmit its gene therapy for approval. The hold was imposed after the detection of these findings in the CAMPSIITE study.Why it mattersRegenxbio's gene therapy, RGX-121, is being investigated as a treatment for Hunter syndrome, a rare genetic disorder. The FDA's clinical hold is a significant setback for the company, which had planned to resubmit its application for approva