FDA reopens review of Regenxbio's Hunter syndrome gene therapy
TL;DR Summary
The FDA is reconsidering Regenxbio’s experimental gene therapy for mucopolysaccharidosis type II (Hunter syndrome) after previously rejecting it, part of a series of recent agency reversals amid leadership changes; the case follows another reversal where UniQure moved to submit a Huntington’s disease gene therapy previously spurned by the agency.
- FDA reverses course on Regenxbio’s childhood gene therapy after rejection statnews.com
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- In another reversal for rare disease field, FDA to reconsider Regenxbio gene therapy Fierce Biotech
- RGNX Retail Investors See Hope As FDA Reopens Door For Regenxbio’s Hunter Syndrome Therapy Yahoo Finance
- REGENXBIO to resubmit application for Hunter gene therapy after FDA’s most recent pivot BioSpace
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