FDA accepts uniQure's BLA for Huntington's disease gene therapy, granting priority review
The filing sets up a regulatory decision on what would be a first gene therapy for the inherited neurodegenerative disease, though approval remains uncertain.
Read at Pharmaceutical Technology →Full coverage · 15 outlets
- Pharmaceutical Technology · lead
- NR TimesFDA grants priority review to Huntington’s disease gene therapy
- Medical DailyFDA accepts uniQure's one-time Huntington's gene therapy for review-but approval is still uncertain
- BioPharm InternationalFDA Accepts uniQure’s Huntington’s Disease Gene Therapy BLA for Priority Review
- NeurologyLiveFDA Grants Priority Review to Huntington Disease Gene Therapy BLA
- HDBuzzFDA sets May 2027 decision date on AMT-130 gene therapy for HD
- Genetic Engineering and Biotechnology NeFDA Sets May 1 PDUFA Action Date for uniQure’s Huntington’s Disease Gene Therapy
- Neurology AdvisorFDA Grants Priority Review to Novel Huntington Disease Gene Therapy
- TradingViewuniQure gains FDA Priority Review for Huntington's disease gene therapy
- AllSciFDA grants uniQure’s Huntington’s gene therapy Priority Review on small, externally controlled dataset
- TOKENPOSTuniQure Says FDA Grants Priority Review to Huntington’s Gene Therapy
- GuruFocusFDA Accepts uniQure's BLA for Huntington's Gene Therapy, Ticker QURE Sees Mixed Signals
- GlobeNewswireuniQure Announces FDA Acceptance and Priority Review of the
- PluangFDA accepts and grants priority review to uniQu...
- BioSpaceUniQure files for FDA, UK approval of first gene therapy for Huntington’s disease