The Bull Case For Amgen (AMGN) Could Change Following EU Nod for Uplizna in Rare Disease

• Recently, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Amgen’s Uplizna for treating immunoglobulin G4-related disease (IgG4-RD) in adults, based on strong Phase 3 data indicating significant efficacy where no authorized therapies currently exist in the EU.
• This milestone highlights the potential impact of Amgen’s pipeline in addressing rare autoimmune disorders with unmet medical needs in major markets.
• We'll examine how European regulatory progress for Uplizna may enhance Amgen's investment case and support its targeted biologics strategy.

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Amgen Investment Narrative Recap

To own Amgen, you need to believe that its innovative pipeline and global scale can outpace drug pricing pressures and biosimilar competition, driving steady returns from targeted therapies and biologics. The recent EMA recommendation for Uplizna boosts near-term confidence in Amgen’s scientific capabilities, but it does not meaningfully shift the most important near-term catalyst: successful commercialization of major late-stage assets. Persistent pricing and patent risks, especially regarding Prolia and future biosimilar launches, remain the dominant business concern.

Among recent announcements, the CHMP’s positive opinion for Tezspire, Amgen’s biologic for chronic rhinosinusitis with nasal polyps, stands out as directly relevant to the Uplizna news. Both illustrate growing recognition of Amgen’s late-stage pipeline in Europe, reinforcing the broader thesis that regulatory success in complex, under-treated diseases supports Amgen’s momentum in targeted immunology and rare disease franchises.

Yet, while the regulatory path looks encouraging, investors should also keep in mind the potential for continued price erosion and policy shifts that...

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

Amgen's narrative projects $37.4 billion in revenue and $8.2 billion in earnings by 2028. This requires 2.3% yearly revenue growth and a $1.6 billion earnings increase from $6.6 billion currently.

Uncover how Amgen's forecasts yield a $311.88 fair value, a 9% upside to its current price.

Exploring Other Perspectives

If you’re viewing Amgen’s prospects through the lens of the most optimistic analysts, pre-news estimates called for US$42.8 billion in revenue and US$13.3 billion in earnings by 2028, with higher profit margins. These analysts focus on Amgen’s ability to deliver frequent high-impact launches, suggesting less vulnerability to industry-wide pricing pressures. The news on Uplizna approval could support this bullish view, but your outlook may differ as expectations and risks shift. Consider how different forecasts could impact your thesis.

Explore 5 other fair value estimates on Amgen - why the stock might be worth over 2x more than the current price!

Build Your Own Amgen Narrative

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

• A great starting point for your Amgen research is our analysis highlighting 4 key rewards and 1 important warning sign that could impact your investment decision.
• Our free Amgen research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Amgen's overall financial health at a glance.

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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.

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