FDA accepts uniQure's AMT-130 for priority review, sets May 2027 decision on Huntington's gene therapy
A May 2027 PDUFA date and a likely advisory committee make this the furthest-advanced gene therapy for Huntington's disease, based on a small externally controlled dataset.
Read at Biopharmadive →Full coverage · 16 outlets
- Biopharmadive · lead
- GlobeNewswireuniQure Announces FDA Acceptance and Priority Review of the
- Huntington's Disease NewsFDA grants priority review to gene therapy for Huntington’s
- Yahoo FinanceUniQure gets an FDA decision date; Teva scraps brain drug study
- pharmaphorumuniQure set for May FDA verdict on Huntington's gene therapy
- DealroomFDA accepts uniQure's Huntington's gene therapy for priority review
- NeurologyLiveFDA Grants Priority Review to Huntington Disease Gene Therapy BLA
- Fierce BiotechFDA grants uniQure’s Huntington’s gene therapy priority review, teeing up ‘defining milestone’
- HDBuzzFDA sets May 2027 decision date on AMT-130 gene therapy for HD
- GuruFocusuniQure's Gene Therapy BLA for Huntington's Disease Gains FDA Pr
- AllSciFDA grants uniQure’s Huntington’s gene therapy Priority Review on small, externally controlled dataset
- Genetic Engineering and Biotechnology NeFDA Sets May 1 PDUFA Action Date for uniQure’s Huntington’s Disease Gene Therapy
- WTVBFDA to review uniQure’s Huntington’s gene therapy, decision due on May 2027
- BioPharm InternationalFDA Accepts uniQure’s Huntington’s Disease Gene Therapy BLA for Priority Review
- TradingViewuniQure gains FDA Priority Review for Huntington's disease gene therapy
- Mugglehead Investment MagazineuniQure gains FDA priority review for Huntington's gene therapy