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    uniQure (QURE) Is Up 9.4% After FDA Deems AMT-130 Phase I/II Data Inadequate for Filing

    Simply Wall St·12/25/2025 13:24:52
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    • 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.
    • We’ll now examine how the FDA’s indication that Phase I/II data may not support an AMT-130 filing affects uniQure’s investment narrative.

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    uniQure Investment Narrative Recap

    To own uniQure, you need to believe that AMT-130 can still become a first-in-class Huntington’s disease treatment and anchor a broader gene therapy platform, despite delays and ongoing losses. The FDA’s signal that current Phase I/II data is unlikely to support a BLA appears to push out the key near term catalyst and heightens the central risk around regulatory timing and uniQure’s heavy dependence on this single program.

    The most relevant recent announcement is the FDA’s April 2025 Breakthrough Therapy designation for AMT-130, which, together with RMAT status, had framed expectations for an accelerated approval path. The December 2025 feedback now sits in sharp contrast to those expedited designations, refocusing attention on upcoming FDA discussions in Q1 2026 as a critical checkpoint for how quickly AMT-130 can realistically move toward any filing.

    Yet behind the promise of AMT-130, investors should be aware of how a prolonged regulatory path could interact with uniQure’s ongoing losses and...

    Read the full narrative on uniQure (it's free!)

    uniQure's narrative projects $306.4 million revenue and $32.3 million earnings by 2028. This requires 147.5% yearly revenue growth and a $249.9 million earnings increase from $-217.6 million today.

    Uncover how uniQure's forecasts yield a $55.44 fair value, a 120% upside to its current price.

    Exploring Other Perspectives

    QURE 1-Year Stock Price Chart
    QURE 1-Year Stock Price Chart

    Six fair value estimates from the Simply Wall St Community span roughly US$13.55 to US$354.90 per share, showing how far apart individual views can be. When you set those numbers against uniQure’s reliance on a successful AMT-130 regulatory outcome, it underlines why many investors study multiple perspectives before deciding how this story might affect the company’s future performance.

    Explore 6 other fair value estimates on uniQure - why the stock might be a potential multi-bagger!

    Build Your Own uniQure Narrative

    Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

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    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.