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    Assessing Legend Biotech (LEGN) Valuation After FDA Draft Guidance Favors CARTITUDE 6 Trial Design

    Simply Wall St·02/17/2026 18:20:46
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    Recent FDA draft guidance supporting Minimal Residual Disease negativity and complete response rate as expedited approval endpoints in multiple myeloma has put fresh attention on Legend Biotech (LEGN) and its CARTITUDE-6 trial design.

    See our latest analysis for Legend Biotech.

    Despite the positive regulatory backdrop and the recent appointment of Gareth Kung to the board and as Audit Committee chair, Legend Biotech’s shares have been under pressure, with a 30 day share price return of a 20.6% decline and a 1 year total shareholder return of a 54% decline. This suggests that sentiment around execution risk and timelines has cooled even as interest in its CARTITUDE 6 program builds.

    If this FDA news has you looking across the sector, it could be a good time to see what our screener turns up in healthcare focused AI, including 25 healthcare AI stocks as potential ideas to research next.

    With Legend Biotech’s shares down sharply over 1 year, even as FDA guidance appears aligned with its lead program and analysts publish higher price targets, investors now face a key question: is this weakness a potential opportunity or is the market already pricing in future growth?

    Most Popular Narrative: 72.8% Undervalued

    Legend Biotech’s most followed narrative places fair value at $64.73 per share versus the last close at $17.58, framing a wide valuation gap that hinges on how investors view CARVYKTI driven growth and long range profitability.

    Significant expansion potential in both earlier lines of therapy and frontline settings for multiple myeloma, driven by strong survival data, ongoing clinical trials (CARTITUDE 5 and 6), and label updates that increase patient access, setting up long term revenue acceleration as the patient pool widens.

    Read the complete narrative.

    Want to see how this story turns projected revenue ramps into a much higher future earnings base and premium multiples, all discounted back using a defined rate and timelines that many investors may not be factoring in yet?

    Result: Fair Value of $64.73 (UNDERVALUED)

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

    However, you still have to weigh concentration in CARVYKTI and reliance on partners like Janssen, where safety issues, competition or contract shifts could quickly weaken this upside case.

    Find out about the key risks to this Legend Biotech narrative.

    Next Steps

    If this setup has you torn between caution and optimism, take a moment to review the numbers yourself. Then move quickly to shape your own view, starting with 3 key rewards.

    Ready to broaden your watchlist?

    If Legend Biotech has sharpened your focus on risk, reward and timing, do not stop here. Use the screener to size up fresh ideas today.

    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.