NasdaqGS:QUREBiotechs
uniQure (QURE) Is Up 9.4% After FDA Deems AMT-130 Phase I/II Data Inadequate for Filing
In December 2025, uniQure reported that final minutes from its pre-Biologics License Application meeting showed the FDA views existing Phase I/II data for AMT-130 as insufficient to support a filing, pushing the company to seek further regulatory discussions in fiscal Q1 2026.
This feedback directly affects the timeline and evidence required for AMT-130 in Huntington’s disease, potentially reshaping how investors assess uniQure’s lead gene therapy program within its broader pipeline.
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