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Unicure said AMT-130 entered FDA priority review with a target PDUFA date of May 1, 2027. Cash, cash equivalents, and investment securities totaled $768.4 million as of September 30, 2026 and are expected to fund operations into 2030.
uniQure reported FDA acceptance of ifezuntirgene inilparvovec for Priority Review on November 2 2026, targeting May 1, 2027. The confirmatory study will enroll approximately 200 patients in a 2:1 ratio of ifezuntirgene inilparvovec to standard of care, with a 36-month endpoint.
uniQure N.V. received FDA Priority Review for ifezuntirgene inilparvovec (AMT-130) in Huntington’s disease, with a PDUFA target action date of May 1, 2027. Cash of $768.4 million as of September 30, 2026 is expected to fund operations into 2030.
uniQure announced that the FDA accepted for review ifezuntirgene inilparvovec’s Biologics License Application for Huntington’s disease, granting Priority Review with a PDUFA target action date of May 1, 2027; the FDA tentatively plans an Advisory Committee meeting.
uniQure N.V. reported that ifezuntirgene inilparvovec slowed Huntington’s disease progression at 36 months by 80% on cUHDRS (nominal p=0.005) and 67% on TFC (nominal p=0.011); at 48 months, cUHDRS slowing was 44% (p=0.144) and TFC slowing was 61% (nominal p=0.008).
