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Home › PDUFA Calendar › QURE

QURE PDUFA Date: Ifezuntirgene inilparvovec

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET
FDA decision (PDUFA) target May 1, 2027 · uniQure N.V. · Huntington's disease (Accelerated Approval pathway; FDA tentatively plans an advisory committee)
Source: uniQure 8-K 2026-11-02 (EX-99.1, BLA accepted, priority review). “The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027.”

Key facts

FDA PDUFA target date2027-05-01
Drug / candidateIfezuntirgene inilparvovec (AMT-130)
IndicationHuntington's disease (Accelerated Approval pathway; FDA tentatively plans an advisory committee)
CompanyuniQure N.V.
Market-cap tierSmall

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FAQ

When is the QURE PDUFA date?
The FDA PDUFA target date for QURE (uniQure N.V.) is 2027-05-01 for Ifezuntirgene inilparvovec (AMT-130). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is QURE's drug Ifezuntirgene inilparvovec?
Ifezuntirgene inilparvovec (AMT-130) is uniQure N.V.'s candidate under FDA review for Huntington's disease (Accelerated Approval pathway; FDA tentatively plans an advisory committee).