https://www.live-feeds.com/feed/fda-pauses-regenxbio-gene-therapy-trial-again-due-to-safety-concernsContinuously updated, source-cited coverage. https://www.live-feeds.com/feed/fda-pauses-regenxbio-gene-therapy-trial-again-due-to-safety-concernshttps://www.live-feeds.com/feed/fda-pauses-regenxbio-gene-therapy-trial-again-due-to-safety-concerns#u49274Wed, 26 Aug 2026 13:10:14 +0000The FDA has placed a clinical hold on Regenxbio's gene therapy for Hunter syndrome, citing safety concerns. This action halts testing and disrupts the company's plans to resubmit its application. The hold stems from findings related to spine MRI scans. The news coincided with a crash in RGNX stock prices.Why it mattersHunter syndrome is a rare genetic disorder requiring specialized treatment. This is not the first time the FDA has paused this specific trial. The resubmission process is now stymied by the current regulatory hold.What is confirmedThe FDA placed a clinical hold on Regen