This report was first published by Endpoints News. To see the original version, click here
The FDA has rejected Regenxbio’s gene therapy for a serious inherited disease called Hunter syndrome in a decision that could reverberate to other rare disease drugmakers as well.
The complete response letter comes shortly after the FDA suspended a clinical trial for RGX-121, when a patient who received another Regenxbio gene therapy for a different condition was found to have a brain tumor.
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