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HealthFDA places clinical hold on Regenxbio’s Hunter syndrome gene therapy

Regenxbio said the U.S. FDA placed its experimental gene therapy for a rare inherited disorder on clinical hold after spinal scans showed abnormalities in five participants. Its shares fell more than 24% in premarket trading.

Regenxbiogene therapyHunter syndromeFDA

RReuters★★★☆☆2026-08-24 14:50Original

FDA places clinical hold on Regenxbio’s Hunter syndrome gene therapy
FDA places clinical hold on Regenxbio’s Hunter syndrome gene therapyHealth