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    Does FDA’s UPLIZNA gMG Expansion Reshape the Bull Case for Amgen’s Diversification Story (AMGN)?

    Simply Wall St·12/26/2025 02:21:22
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    • Earlier this month, the Muscular Dystrophy Association highlighted the U.S. FDA’s approval of Amgen’s UPLIZNA (inebilizumab-cdon) for adults with generalized myasthenia gravis who are both AChR- and MuSK-antibody positive, making it the first and only CD19-targeted B-cell therapy cleared for this condition.
    • This approval broadens Amgen’s autoimmune footprint by extending an already-approved B-cell therapy into a third indication, potentially reinforcing the company’s efforts to diversify revenue beyond its mature bone-health and oncology franchises.
    • Now we’ll examine how expanding UPLIZNA into generalized myasthenia gravis could influence Amgen’s investment narrative around pipeline breadth and diversification.

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    Amgen Investment Narrative Recap

    To own Amgen, you generally need to believe that its mature franchises can fund a broad, de-risked pipeline that steadily adds new indications and therapies, while biosimilar and pricing pressures remain manageable. The UPLIZNA approval in generalized myasthenia gravis supports that diversification story, but it does not change the fact that near term, the biggest swing factor is how quickly biosimilars chip away at core bone-health revenues and how much pricing pressure compresses margins.

    Among recent developments, the FDA’s full approval of IMDELLTRA for extensive stage small cell lung cancer matters most here, because it sits alongside UPLIZNA as another example of Amgen trying to offset maturing legacy products with newer oncology and autoimmune assets. Together, these approvals highlight why upcoming readouts and launches across the pipeline may be more important to the stock’s catalyst path than any single product, even as biosimilar competition in Prolia and related franchises looms large.

    Yet, against those growth efforts, intensifying global efforts to regulate and cap drug prices remain a risk investors should be aware of, because...

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

    Amgen’s narrative projects $37.4 billion revenue and $8.2 billion earnings by 2028.

    Uncover how Amgen's forecasts yield a $322.88 fair value, a 3% downside to its current price.

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    Some of the most optimistic analysts already expected Amgen to reach about US$42.8 billion in revenue and US$13.3 billion in earnings by 2028, so UPLIZNA’s new approval could either reinforce that bullish view on pipeline breadth or prompt a rethink if pricing and patent risks prove harder to offset than those forecasts assume.

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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.