Sonrotoclax’s Priority Review And Strong Early Data Could Be A Game Changer For BeOne Medicines (ONC)

• In late November and early December 2025, BeOne Medicines reported positive Phase 1/2 data for its investigational BCL2 inhibitor sonrotoclax in relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukemia, alongside U.S. FDA Priority Review, Breakthrough Therapy, Fast Track and multiple Orphan Drug designations, plus participation in Project Orbis.
• The new data, including an overall response rate of 52.4% in heavily pretreated mantle cell lymphoma and rapid, sustained undetectable minimal residual disease rates in treatment-naive chronic lymphocytic leukemia, positions sonrotoclax as a potential backbone therapy across B-cell malignancies if regulatory reviews ultimately support approval.
• Next, we’ll examine how sonrotoclax’s Priority Review status and early efficacy signals affect BeOne’s oncology-driven growth narrative and risk profile.

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BeOne Medicines Investment Narrative Recap

To own BeOne Medicines, you need to believe that its hematology and oncology portfolio can expand beyond BRUKINSA and CLL into broader B cell malignancies, with sonrotoclax emerging as a second major revenue driver. The latest Phase 1/2 data and FDA Priority Review strengthen the near term catalyst around a potential R/R MCL approval, but they do not remove the central risk of heavy dependence on a small number of core oncology assets.

The most relevant recent announcement is the U.S. FDA’s Priority Review of sonrotoclax for relapsed or refractory mantle cell lymphoma, supported by a 52.4% overall response rate in heavily pretreated patients and manageable safety. This accelerates the regulatory timeline, aligns with BeOne’s broader oncology growth story and, if successful, could partially offset concentration risk in BRUKINSA and the CLL franchise over time.

Yet even with sonrotoclax advancing, investors should be aware that revenue concentration in a few oncology assets still leaves BeOne exposed to...

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

BeOne Medicines' narrative projects $7.6 billion revenue and $1.3 billion earnings by 2028. This requires 18.6% yearly revenue growth and about a $1.48 billion earnings increase from -$177.6 million today.

Uncover how BeOne Medicines' forecasts yield a $398.60 fair value, a 22% upside to its current price.

Exploring Other Perspectives

Six members of the Simply Wall St Community currently place BeOne’s fair value between US$250 and about US$734.93, highlighting very different expectations. You can set those views against the company’s growing reliance on oncology approvals such as sonrotoclax, which may influence how resilient its earnings profile really is over time.

Explore 6 other fair value estimates on BeOne Medicines - why the stock might be worth 23% less than the current price!

Build Your Own BeOne Medicines 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 BeOne Medicines research is our analysis highlighting 5 key rewards and 1 important warning sign that could impact your investment decision.
• Our free BeOne Medicines research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate BeOne Medicines' 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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