• EN

    • -+ 0.00%
    -+ 0.00%
    -+ 0.00%

    uniQure (QURE): Reassessing Valuation After FDA Sets Higher Bar for AMT-130 Approval Pathway

    Simply Wall St·12/07/2025 04:27:16
    Listen to the news

    uniQure (NasdaqGS:QURE) just hit a key regulatory speed bump, with the FDA signaling that current Phase I/II data for its AMT-130 Huntington’s program likely will not carry a Biologics License Application.

    See our latest analysis for uniQure.

    The setback has hit sentiment hard in the short term, with a 1 week share price return of minus 22.46 percent and a 30 day share price return of minus 23.25 percent. However, momentum is still positive versus earlier in the year given a 90 day share price return of 22.38 percent and a standout 1 year total shareholder return of 186.31 percent, even though longer term total shareholder returns over three and five years remain negative and signal that confidence is still rebuilding rather than firmly established.

    If this kind of binary regulatory risk has you rethinking concentration in a single biotech, it could be worth scanning healthcare stocks to see what else the market is repricing.

    With shares still up sharply over twelve months but now trading at a steep discount to analyst targets, investors face a key question: Is uniQure a beaten down gene therapy mispricing, or is the market correctly discounting future growth?

    Most Popular Narrative: 63.4% Undervalued

    With uniQure last closing at $21.33 against a most popular narrative fair value of $58.21, the valuation gap implies substantial upside if assumptions play out.

    The analysts have a consensus price target of $35.514 for uniQure based on their expectations of its future earnings growth, profit margins and other risk factors. However, there is a degree of disagreement amongst analysts, with the most bullish reporting a price target of $69.56, and the most bearish reporting a price target of just $13.41.

    Read the complete narrative.

    Want to see what kind of revenue surge, margin pivot, and future earnings multiple could possibly justify that gap? The narrative lays out an aggressive transformation roadmap. Curious how bold those assumptions really are? Dive in to see the full story behind this valuation call.

    Result: Fair Value of $58.21 (UNDERVALUED)

    Have a read of the narrative in full and understand what's behind the forecasts.

    However, lingering FDA uncertainty around AMT-130 and weakening near term revenues mean any further regulatory setbacks could quickly unwind this bullish valuation narrative.

    Find out about the key risks to this uniQure narrative.

    Build Your Own uniQure Narrative

    If you see the story differently or want to stress test the assumptions with your own inputs, you can build a custom view in minutes: Do it your way.

    A great starting point for your uniQure research is our analysis highlighting 2 key rewards and 3 important warning signs that could impact your investment decision.

    Looking for more investment ideas?

    Before you move on, lock in an edge by scanning fresh opportunities with the Simply Wall St Screener so your next move is intentional, not accidental.

    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.