UniQure climbs as FDA deems accelerated approval filing 'reasonable' for Huntington's therapy
BUZZ-UniQure climbs as FDA deems accelerated approval filing 'reasonable' for Huntington's therapy ** U.S.-listed shares of drug developer uniQure UQ1.F, QURE.O rise 8% to $39.64
** uniQure says it is on track to file Huntington's disease gene therapy AMT-130 for approval in U.S., UK in Q3
** U.S. FDA told uniQure accelerated approval filing based on current data is reasonable, while discussions on confirmatory study continue
** In June, FDA reversed its earlier position and said it will accept existing trial data
** Cantor analyst Kristen Kluska says FDA meeting minutes "support a path" toward license application, but flags "holes" in Qure's analyses that "FDA does appear to be scrutinizing"
** Kluska is "leaning bullish on QURE for now, but... a bit more cautious," adding its "package wasn't perfect"
** uniQure plans to report four-year data from 24 patients in September
** Also reports Q2 sales of $5.8 mln vs analysts' est of $5.47 mln - LSEG-compiled data
** Including session's moves, stock up 64% YTD
(Reporting by Kamal Choudhury in Bengaluru)
Recent news on uniQure
See all newsuniQure tumbles after updated Huntington's disease gene therapy data
UniQure plunges as Huntington's trial data disappoints investors (updated)
uniQure tumbles after updated Huntington's disease gene therapy data
UniQure's Huntington's therapy fails to significantly slow disease progression in trial
uniQure seeks US approval for Huntington's gene therapy after FDA reversal