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uniQure submits FDA and MHRA filings for AMT-130

uniQure submitted a BLA to the FDA seeking accelerated approval and an MAA to the MHRA for ifezuntirgene inilparvovec (AMT-130), supported by three-year Phase I/II data showing slowed disease progression.

QURE

uniQure submitted a BLA to the FDA requesting accelerated approval and an MAA to the MHRA for ifezuntirgene inilparvovec (AMT-130), supported by three-year Phase I/II data showing slowed disease progression.Key Highlights:Original SEC Filing: uniQure N.V. [ QURE ] - 8-K - Sep.

02, 2026This is an AI…