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FDA grants priority review to uniQure's Huntington's gene therapy, with May 2027 decision date
A decision on the one-time therapy would be the first FDA verdict on a gene therapy for Huntington's disease, though the agency appears likely to convene an advisory committee.
PharmaphorumuniQure set for May FDA verdict on Huntington's gene therapyNeurologyliveFDA Grants Priority Review to Huntington Disease Gene Therapy BLAHuntingtonsdiseasenewsFDA grants priority review to gene therapy for Huntington’sMedicaldailyFDA accepts uniQure's one-time Huntington's gene therapy for review-but approval is still uncertainDrugdiscoverynewsGene therapy for Huntington's disease reaches FDA reviewDealroomFDA accepts uniQure's Huntington's gene therapy for priority reviewYahooUniQure gets an FDA decision date; Teva scraps brain drug studyFiercebiotechFDA grants uniQure’s Huntington’s gene therapy priority review, teeing up ‘defining milestone’AllsciFDA grants uniQure’s Huntington’s gene therapy Priority Review on small, externally controlled datasetTokenpostuniQure Says FDA Grants Priority Review to Huntington’s Gene TherapyInklHuntington's Gene Therapy AMT-130 Gets FDA Priority Review and a May 2027 Decision Date, Advisory Panel PlannedPluangFDA accepts and grants priority review to uniQu...HdbuzzFDA sets May 2027 decision date on AMT-130 gene therapy for HDGlobenewswireuniQure Announces FDA Acceptance and Priority Review of the