Bristol Myers Squibb (BMY) Is Up 6.4% After EU Approves Breyanzi for Mantle Cell Lymphoma

• In November 2025, Bristol Myers Squibb announced that the European Commission approved Breyanzi, its CAR-T cell therapy, for adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a BTK inhibitor. This expanded approval in Europe follows strong clinical data from the TRANSCEND NHL 001 trial and broadens access to innovative cell therapy for eligible patients across EU and EEA countries.
• The approval highlights Bristol Myers Squibb’s progress in advancing its oncology portfolio and points to the company’s growing presence in the European cell therapy market.
• We’ll examine how Breyanzi’s expanded European approval could reshape Bristol Myers Squibb’s investment narrative and late-stage innovation.

These 13 companies survived and thrived after COVID and have the right ingredients to survive Trump's tariffs. Discover why before your portfolio feels the trade war pinch.

Bristol-Myers Squibb Investment Narrative Recap

To be a shareholder of Bristol-Myers Squibb, you need to believe in the company’s ability to offset imminent patent cliffs by delivering successful new launches and maintaining momentum from recent approvals like Breyanzi’s expanded indication in Europe. While this approval reinforces late-stage innovation and adds to pipeline strength, it does not fundamentally change the immediate risk posed by generic competition for key drugs such as Eliquis and Opdivo over the coming years.

Among recent announcements, the halted milvexian trial is particularly relevant. After an interim analysis suggested the study would not meet its primary endpoint in post-acute coronary syndrome patients, it highlighted the ongoing challenges in pipeline execution and validation, reinforcing how pivotal each late-stage asset is for bridging the inevitable revenue gap from upcoming patent expiries.

In contrast, investors should be aware that concentrated exposure to a few major therapies leaves Bristol-Myers particularly vulnerable to pipeline setbacks and regulatory changes...

Read the full narrative on Bristol-Myers Squibb (it's free!)

Bristol-Myers Squibb is projected to generate $41.3 billion in revenue and $9.2 billion in earnings by 2028. This outlook is based on a forecasted annual revenue decline of 4.7% and an increase in earnings of $4.2 billion from the current $5.0 billion.

Uncover how Bristol-Myers Squibb's forecasts yield a $53.00 fair value, a 8% upside to its current price.

Exploring Other Perspectives

Fair value estimates from 11 Simply Wall St Community members range from US$50 to US$117.66 per share. This broad spread underscores how beliefs about the impact of upcoming generic competition and product launches can shape expectations for Bristol-Myers Squibb’s long-term performance.

Explore 11 other fair value estimates on Bristol-Myers Squibb - why the stock might be worth just $50.00!

Build Your Own Bristol-Myers Squibb 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 Bristol-Myers Squibb research is our analysis highlighting 5 key rewards and 2 important warning signs that could impact your investment decision.
• Our free Bristol-Myers Squibb research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Bristol-Myers Squibb's overall financial health at a glance.

No Opportunity In Bristol-Myers Squibb?

Don't miss your shot at the next 10-bagger. Our latest stock picks just dropped:

• This technology could replace computers: discover 28 stocks that are working to make quantum computing a reality.
• The latest GPUs need a type of rare earth metal called Terbium and there are only 35 companies in the world exploring or producing it. Find the list for free.
• The end of cancer? These 29 emerging AI stocks are developing tech that will allow early identification of life changing diseases like cancer and Alzheimer's.

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.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com