Did Multiple FDA Approvals Just Shift Johnson & Johnson's (JNJ) Innovation Narrative in Biopharma?

• In September 2025, Johnson & Johnson announced multiple U.S. FDA approvals, including a new subcutaneous induction regimen for TREMFYA in ulcerative colitis and INLEXZO for bladder cancer, alongside positive late-stage clinical trial results in multiple myeloma and psoriasis.
• These milestones position Johnson & Johnson as a leader in developing innovative treatments that address major unmet medical needs across immunology, oncology, and dermatology.
• We'll explore how these approvals, particularly for new administration routes in inflammatory diseases, influence Johnson & Johnson's growth outlook and investment thesis.

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Johnson & Johnson Investment Narrative Recap

To be a Johnson & Johnson shareholder today, you need to believe in the company’s ability to offset upcoming patent expirations, particularly the loss of exclusivity for STELARA, through innovation and its robust late-stage pipeline. The recent string of FDA approvals, especially new treatments and administration options in immunology and oncology, offers support to Johnson & Johnson’s innovation story, but does not materially shift the immediate risk of biosimilar competition eroding revenue in the near term.

Of the recent announcements, the FDA approval of a subcutaneous induction regimen for TREMFYA in ulcerative colitis is especially relevant, as it strengthens the company's immunology portfolio and reflects efforts to sustain revenue following potential losses from patent cliffs. This development is closely tied to Johnson & Johnson’s core catalyst: expanding its pipeline to preserve growth amid exclusivity and competitive pressures.

Yet, in contrast to product wins, investors should be mindful of the potential consequences if STELARA biosimilar competition hits harder or sooner than...

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

Johnson & Johnson's narrative projects $104.1 billion revenue and $22.9 billion earnings by 2028. This requires 4.7% yearly revenue growth and a $0.2 billion increase in earnings from $22.7 billion today.

Uncover how Johnson & Johnson's forecasts yield a $177.47 fair value, in line with its current price.

Exploring Other Perspectives

Fair value estimates from 23 members of the Simply Wall St Community range from US$133 to US$177.47 per share. While the community’s outlook varies widely, the biggest current challenge remains protecting profits as key drugs lose exclusivity, which could weigh on the company’s long-term returns.

Explore 23 other fair value estimates on Johnson & Johnson - why the stock might be worth 24% less than the current price!

Build Your Own Johnson & Johnson 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 Johnson & Johnson research is our analysis highlighting 3 key rewards and 3 important warning signs that could impact your investment decision.
• Our free Johnson & Johnson research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Johnson & Johnson'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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