Merck (MRK) Is Up 9.6% After Keytruda-Padcev Combo Wins FDA Nod for Bladder Cancer

Simply Wall St
  • Merck received FDA approval for Keytruda (including the new subcutaneous Keytruda QLEX) in combination with Padcev for use before and after surgery in adults with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy.
  • This milestone not only expands Merck's oncology treatment options, but also highlights global regulatory collaboration through the expedited Project Orbis review process.
  • We'll explore how this high-impact approval strengthens Merck's pipeline outlook and the investment narrative for the years ahead.

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Merck Investment Narrative Recap

To be a Merck shareholder, you need to believe in the company's ability to maintain revenue growth after KEYTRUDA’s eventual loss of exclusivity, supported by its expanding pipeline and new approvals. The recent FDA approval for KEYTRUDA (including Keytruda QLEX) and Padcev in muscle-invasive bladder cancer reinforces short-term pipeline strength but does not eliminate the long-term risk of a post-KEYTRUDA revenue cliff.

One compelling recent announcement tied to Merck’s catalyst theme is the positive Phase 3 results for the oral doravirine/islatravir HIV-1 treatment, with FDA review underway. This underscores Merck’s push to broaden its portfolio with late-stage assets that can fund growth as older products face headwinds.

In contrast, investors should also be alert to the possibility of KEYTRUDA-facing generic competition sooner than expected if...

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

Merck's narrative projects $72.0 billion in revenue and $24.3 billion in earnings by 2028. This requires 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 $104.27 fair value, in line with its current price.

Exploring Other Perspectives

MRK Community Fair Values as at Nov 2025

Thirty Simply Wall St Community members estimate Merck's fair value between US$77 and US$216 per share. While new growth drivers abound, the looming risk of a KEYTRUDA revenue gap remains a key concern for future performance.

Explore 30 other fair value estimates on Merck - why the stock might be worth over 2x more than the current price!

Build Your Own Merck Narrative

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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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