Did FDA Approval of Subcutaneous KEYTRUDA QLEX Just Shift Merck’s (MRK) Investment Narrative?

• On September 19, 2025, Merck announced that the U.S. Food and Drug Administration approved KEYTRUDA QLEX, the first subcutaneous formulation of its blockbuster cancer drug, for use in adults across most solid tumor indications, with U.S. availability expected in late September.
• This new version significantly reduces administration time to just one to two minutes, increasing convenience for patients and care teams and supporting Merck’s ongoing efforts to defend its oncology leadership as biosimilar competition approaches.
• Now, we will examine how the approval of subcutaneous KEYTRUDA QLEX may reinforce Merck’s growth narrative and product pipeline outlook.

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Merck Investment Narrative Recap

To be a Merck shareholder, you need to believe the company can sustain long-term growth as KEYTRUDA, its top-selling drug, approaches loss of exclusivity. The recent FDA approval of KEYTRUDA QLEX, a new subcutaneous formulation, may strengthen Merck’s short-term competitive position and support oncology franchise resilience but does not materially alter the largest risk, future revenue pressure from biosimilar competition as KEYTRUDA's exclusivity nears its end.

Among recent announcements, the collaboration with Variational AI stands out for its potential to enhance Merck’s drug discovery pipeline using artificial intelligence. This is relevant because Merck’s ability to bring innovative therapies to market rapidly is becoming more critical as existing revenue streams, especially from KEYTRUDA, face future threats.

However, investors should be aware, despite KEYTRUDA QLEX’s benefits, the biggest challenge remains...

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

Merck's outlook anticipates revenue of $72.0 billion and earnings of $24.3 billion by 2028. This forecasts an annual revenue growth rate of 4.2% and a $7.9 billion earnings increase from current earnings of $16.4 billion.

Uncover how Merck's forecasts yield a $102.33 fair value, a 30% upside to its current price.

Exploring Other Perspectives

Simply Wall St Community members posted 32 separate fair value estimates for Merck, ranging from US$74.77 to as high as US$208.04 per share. While many see deep value, the looming loss of KEYTRUDA exclusivity continues to shape the outlook and is a key factor you cannot ignore when considering where Merck’s performance may head next.

Explore 32 other fair value estimates on Merck - why the stock might be worth just $74.77!

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 6 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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