How Keytruda’s Subcutaneous FDA Approval and Extended Patent Could Shape Merck’s (MRK) Investment Trajectory

In early October 2025, Merck announced FDA approval for a subcutaneous version of Keytruda and shared positive Phase 3 trial outcomes for both Keytruda in several cancer types and Winrevair in pulmonary arterial hypertension, with new research presented at the ESMO Congress in Berlin. The subcutaneous Keytruda formulation extends the drug's patent protection beyond 2028 while enhancing patient and provider convenience, a significant move to reinforce Merck’s oncology leadership amid stiff competition. We'll now consider how the subcutaneous Keytruda approval, extending patent protection, could influence Merck's longer-term investment narrative.

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Merck Investment Narrative Recap

To be a shareholder in Merck, one needs to believe in the company’s ability to extend its oncology leadership, especially through continued innovation of Keytruda and a robust late-stage pipeline. The recent FDA approval of subcutaneous Keytruda appears significant, as it extends patent protection and supports ongoing sales, currently the most important near-term catalyst. However, this development does not materially diminish the risks tied to competition in immuno-oncology or to declining GARDASIL demand in China.

Among recent announcements, positive Phase 3 trial results for WINREVAIR in pulmonary arterial hypertension are particularly relevant. This product's launch strengthens Merck’s position outside oncology and adds another near-term driver, complementing Keytruda’s extended exclusivity. Growth from these new treatments may help buffer the company against volatility in established product lines.

On the other hand, investors should be aware that despite these advances, global competition in the PD-1 inhibitor class remains an ongoing risk to...

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

Merck's outlook anticipates $72.0 billion in revenue and $24.3 billion in earnings by 2028. This scenario is based on analysts projecting 4.2% annual revenue growth and a $7.9 billion increase in earnings from the current $16.4 billion.

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

Exploring Other PerspectivesMRK Community Fair Values as at Oct 2025

Simply Wall St Community members placed Merck’s fair value between US$74.77 and US$207.62, averaging 33 separate forecasts. While new growth drivers generate optimism, strong competition for Keytruda could affect future earnings and challenge these varied perspectives.

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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.

No Opportunity In Merck?

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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.

Companies discussed in this article include MRK.

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