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    Gilead Sciences (GILD) Is Up 7.4% After FDA Expands Yescarta Lymphoma Label Restrictions Removed

    Simply Wall St·02/08/2026 01:13:09
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    • In early February 2026, Kite, a Gilead company, reported that the FDA approved an update to Yescarta’s prescribing information, removing prior use limitations in patients with relapsed or refractory primary central nervous system lymphoma based on Phase 1 data from Dana-Farber Cancer Institute.
    • This change makes Yescarta the only CAR T-cell therapy for relapsed or refractory large B-cell lymphoma without such restrictions in PCNSL, addressing a cancer subset with a five-year survival rate of roughly 30% and an urgent need for better treatment options.
    • We’ll now examine how this FDA label update, which underscores Yescarta’s safety profile in a difficult lymphoma setting, affects Gilead’s investment narrative.

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    What Is Gilead Sciences' Investment Narrative?

    To own Gilead today, you have to believe in a resilient HIV and virology engine, a meaningful oncology growth leg and disciplined capital returns via dividends and buybacks, all supported by solid earnings quality. The Yescarta label update in primary CNS lymphoma slots into that story as a focused, clinically important win for Kite that reinforces Gilead’s presence in cell therapy, but the immediate financial impact looks modest given the ultra-rare setting and the share price already reacting. Near term, the bigger catalysts still sit with Trodelvy data readouts, lenacapavir’s PrEP rollout, and how management deploys cash into further bolt-on deals. On the risk side, Gilead remains exposed to high debt levels, intensifying oncology competition and the need to keep refreshing a concentrated HIV franchise. Yet there is one particular balance sheet risk here that investors should not ignore.

    Gilead Sciences' shares have been on the rise but are still potentially undervalued by 47%. Find out what it's worth.

    Exploring Other Perspectives

    GILD 1-Year Stock Price Chart
    GILD 1-Year Stock Price Chart

    Ten Simply Wall St Community members value Gilead between roughly US$106.93 and US$288.05 per share, underlining how far apart individual views can be. As you weigh those opinions against the recent Yescarta label change and Gilead’s reliance on a few core therapies, it is worth considering how different assumptions on pipeline execution and debt might influence the company’s long term earnings power.

    Explore 10 other fair value estimates on Gilead Sciences - why the stock might be worth 30% less than the current price!

    Build Your Own Gilead Sciences Narrative

    Disagree with this assessment? Create your own narrative 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.