FDA Rejects Regenxbio's Gene Therapy for Hunter Syndrome After Clinical Hold
FDA issues Complete Response Letter rejecting RGX-121 gene therapy for Hunter syndrome, citing trial design concerns. Regenxbio plans to resubmit with additional data.
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FDA Halts REGENXBIO Gene Therapy Trials After Brain Tumor Discovery
REGENXBIO shares drop 32% as FDA places clinical hold on two rare disease gene therapies following brain tumor discovery in trial participant.
REGENXBIO Shares Jump on Promising Duchenne Gene Therapy Results
REGENXBIO stock rises 8% after positive 18-month trial data for RGX-202, its one-time gene therapy treating Duchenne muscular dystrophy in boys.