UniQure gains after FDA green lights Huntington's gene therapy filing
BUZZ-UniQure gains after FDA green lights Huntington's gene therapy filing ** U.S.-listed shares of drug developer uniQure UQ1.F, QURE.O rise 74.4% to $47.06 premarket
** Company plans to submit an application for approval of its Huntington's disease gene therapy called AMT-130 in Q3 of 2026
** Says FDA communicated that three-year analysis from its early- to mid-stage study would be acceptable as the primary basis for its approval application
** "FDA communicated that they would work as expeditiously as possible with uniQure on this effort" - QURE
** Huntington's disease is a rare, genetic neurodegenerative disorder that leads to behavioral abnormalities and cognitive decline
** FDA had previously called for a new study to support the approval of QURE's gene therapy and rejected its most recent trial for not including participants given a placebo
** Up to last close, shares up 12.8% YTD
(Reporting by Sneha S K)
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