uniQure rises after FDA filing for Huntington's gene therapy
BUZZ-uniQure rises after FDA filing for Huntington's gene therapy ** U.S.-listed shares of Dutch gene therapy maker uniQure UQ1.F, QURE.O rise 6.5% to $50.95 premarket
** Co says it has submitted a marketing application to the U.S. FDA seeking accelerated approval of its experimental Huntington's disease treatment, ifezuntirgene inilparvovec (AMT-130)
** After initially raising concerns about relying on early-to-mid-stage data and recommending a controlled study, the agency said in June that the three-year dataset could serve as the primary basis for an accelerated approval filing
** Co says it has requested a priority review for the application
** If granted, the designation would shorten the FDA's review period to six months following the agency's 60-day filing review
** Co plans to present four-year data from its ongoing early-to-mid stage study before the end of Q3
** uniQure says it has also filed a marketing authorization application for the therapy with the United Kingdom's Medicines and Healthcare products Regulatory Agency
** As of last close, stock has doubled YTD
(Reporting by Siddhi Mahatole)
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