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FDA grants priority review to uniQure's AMT-130 for Huntington's disease, sets May 2027 decision date
The FDA accepted uniQure's BLA for its Huntington's disease gene therapy and scheduled a May 1, 2027 PDUFA date, with an advisory committee expected.
ReutersFDA to review uniQure's Huntington's gene therapy, decision due on May 2027Pharmaceutical-technologyFDA to review uniQure’s BLA for Huntington’s gene therapyInklHuntington's Gene Therapy AMT-130 Gets FDA Priority Review and a May 2027 Decision Date, Advisory Panel PlannedDrugdiscoverynewsGene therapy for Huntington's disease reaches FDA reviewHuntingtonsdiseasenewsFDA grants priority review to gene therapy for Huntington’sDealroomFDA accepts uniQure's Huntington's gene therapy for priority reviewYahooUniQure gets an FDA decision date; Teva scraps brain drug studyPharmaphorumuniQure set for May FDA verdict on Huntington's gene therapyNeurologyliveFDA Grants Priority Review to Huntington Disease Gene Therapy BLAFiercebiotechFDA 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 HDAllsciFDA grants uniQure’s Huntington’s gene therapy Priority Review on small, externally controlled datasetGenengnewsFDA Sets May 1 PDUFA Action Date for uniQure’s Huntington’s Disease Gene TherapyBiopharminternationalFDA Accepts uniQure’s Huntington’s Disease Gene Therapy BLA for Priority ReviewTokenpostuniQure Says FDA Grants Priority Review to Huntington’s Gene Therapy