FDA Approval of EPKINLY Combo Might Change the Case for Investing in AbbVie (ABBV)

• In November 2025, AbbVie received full FDA approval for EPKINLY (epcoritamab-bysp) in combination with rituximab and lenalidomide for the treatment of relapsed or refractory follicular lymphoma in adults, based on pivotal Phase 3 data showing significant improvement over the standard of care.
• This regulatory milestone not only converts EPKINLY's earlier accelerated approval to full approval but also marks a meaningful expansion of AbbVie's oncology portfolio in an area of unmet need.
• We'll examine how the FDA approval of EPKINLY combination therapy could influence AbbVie's future earnings outlook and oncology growth narrative.

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AbbVie Investment Narrative Recap

To be a shareholder in AbbVie, you need to believe that its expanding, innovation-oriented pipeline can offset pressures from loss of exclusivity, pricing reforms, and a concentrated product mix. The recent FDA approval of EPKINLY for relapsed or refractory follicular lymphoma strengthens AbbVie's oncology portfolio and could support future earnings, but it does not immediately resolve the critical near-term risk around biosimilar competition or broader pricing pressures facing mature assets.

Among recent announcements, the positive Phase 3 results and new Canadian approval for LUPRON DEPOT highlight AbbVie's focus on therapeutic expansion. While relevant to diversified growth, this move plays more to longer-term catalysts rather than shifting the immediate narrative driven by immunity and oncology product launches.

However, against this backdrop of innovation, investors should be aware that growing revenue from new therapies does not eliminate risks tied to concentrated product exposure and...

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

AbbVie's outlook anticipates $73.0 billion in revenue and $20.8 billion in earnings by 2028. This is based on a 7.7% annual revenue growth rate and an increase in earnings of $17.1 billion from the current $3.7 billion.

Uncover how AbbVie's forecasts yield a $241.29 fair value, in line with its current price.

Exploring Other Perspectives

Simply Wall St Community members have shared four fair value estimates for AbbVie, ranging widely from US$232 to US$433. Exploring these different viewpoints can help you understand how the pace of new product approvals and pipeline momentum may shape future earnings as older exclusivity wanes.

Explore 4 other fair value estimates on AbbVie - why the stock might be worth just $232.00!

Build Your Own AbbVie 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 AbbVie research is our analysis highlighting 2 key rewards and 5 important warning signs that could impact your investment decision.
• Our free AbbVie research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate AbbVie'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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