UniQure gains after FDA green lights Huntington's gene therapy filing
BUZZ-UniQure gains after FDA green lights Huntington's gene therapy filing Updates
** U.S.-listed shares of drug developer uniQure UQ1.F, QURE.O jump 68.9% to more than seven-month high of $45.60
** Company plans to submit an application for approval of its Huntington's disease gene therapy called AMT-130 in Q3 of 2026
** Company says FDA communicated that a 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
** Including session moves, shares up 82% YTD
(Reporting by Sneha S K)
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