FDA Approval of Subcutaneous Keytruda and Pipeline Updates Might Change The Case For Investing In Merck (MRK)

• In October 2025, Merck announced new research findings for over 20 cancer types and multiple treatment settings to be presented at the ESMO Congress, alongside initiating new Phase 2b and 3 trials for its investigational and approved medicines across a range of diseases. Notably, the FDA approval of a subcutaneous form of Keytruda is set to extend patent protection and supports Merck’s late-stage pipeline expansion, adding positive momentum from clinical trial results for key drugs such as Winrevair and tulisokibart.
• Merck’s latest regulatory and clinical trial milestones reinforce its ongoing efforts to enhance oncology leadership and diversify future growth beyond Keytruda.
• We'll now examine how the FDA approval of subcutaneous Keytruda and pipeline progress affect Merck's long-term growth outlook.

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Merck Investment Narrative Recap

To be a Merck shareholder, you likely believe that the strength of its oncology pipeline, led by Keytruda, and an expanding range of innovative medicines can offset future risks tied to patent expiries, competition, and regional sales headwinds. The recent FDA approval of subcutaneous Keytruda enhances short-term momentum and visibility but does not completely resolve Keytruda’s eventual loss of exclusivity, which remains the most important risk in the near term.

One recent highlight directly relevant to pipeline strength is the announcement of positive late-stage results for Winrevair in pulmonary arterial hypertension, together with ongoing launches. This kind of pipeline progress may help Merck diversify revenue streams and cushion the anticipated impact of future Keytruda biosimilar competition.

However, investors should also be aware that, in contrast to the positive news, the risk posed by declining Gardasil sales in China could still weigh on overall growth...

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

Merck's narrative projects $72.0 billion revenue and $24.3 billion earnings by 2028. This requires 4.2% yearly revenue growth and a $7.9 billion earnings increase from $16.4 billion today.

Uncover how Merck's forecasts yield a $102.33 fair value, a 19% upside to its current price.

Exploring Other Perspectives

Thirty-three Simply Wall St Community members estimate Merck’s fair value between US$74.77 and US$207.62 per share. While future growth drivers are in focus, a wide range of views reflects how competition and regulatory risks may influence long-term performance.

Explore 33 other fair value estimates on Merck - why the stock might be worth 13% less than the current price!

Build Your Own Merck 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 Merck research is our analysis highlighting 5 key rewards and 1 important warning sign that could impact your investment decision.
• Our free Merck research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Merck'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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