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    How Tolebrutinib’s MS Setback and China Wins Will Impact Sanofi (ENXTPA:SAN) Investors

    Simply Wall St·12/17/2025 02:17:19
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    • Sanofi recently reported that its PERSEUS Phase 3 trial found the multiple sclerosis drug tolebrutinib failed to delay disability progression in primary progressive MS, leading the company to stop seeking approval for this indication while the FDA review for non‑relapsing secondary progressive MS is pushed beyond the previously expected December 2025 decision date.
    • At the same time, Sanofi has expanded its presence in rare blood disorders in China with approvals for Qfitlia in hemophilia and Cablivi in acquired thrombotic thrombocytopenic purpura, while also signing new AI‑driven antibody and autoimmune collaborations and licensing a potential first‑in‑class Alzheimer’s therapy that together reshape the mix and risk profile of its late‑stage pipeline.
    • We’ll now examine how the tolebrutinib setback and delayed FDA decision affect confidence in Sanofi’s late‑stage pipeline execution and growth outlook.

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    Sanofi Investment Narrative Recap

    To own Sanofi, you need to believe that its diversified pharma and vaccines portfolio, anchored by Dupixent, can offset pricing pressure and mixed pipeline outcomes. The tolebrutinib setback and delayed FDA decision weaken confidence in late stage execution, which has been a key short term catalyst, and reinforce pipeline risk as the main overhang.

    The recent China approvals for Qfitlia and Cablivi are a useful counterpoint, showing Sanofi converting R&D into marketed assets in rare hematology even as multiple sclerosis efforts stumble. They tie directly into the company’s push to broaden growth drivers beyond Dupixent while it absorbs higher R&D and SG&A to support new launches and acquisitions.

    But investors should not overlook how repeated late stage trial failures could compound Sanofi’s existing pipeline execution risk and...

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

    Sanofi’s narrative projects €51.8 billion revenue and €9.6 billion earnings by 2028. This implies 4.2% yearly revenue growth and about a €3.2 billion earnings increase from €6.4 billion today.

    Uncover how Sanofi's forecasts yield a €105.20 fair value, a 30% upside to its current price.

    Exploring Other Perspectives

    ENXTPA:SAN 1-Year Stock Price Chart
    ENXTPA:SAN 1-Year Stock Price Chart

    Nine members of the Simply Wall St Community currently estimate Sanofi’s fair value between €91.46 and €279.61, highlighting very different expectations. Against that backdrop, the latest tolebrutinib failure and regulatory delay put pipeline execution risk firmly in focus for anyone assessing Sanofi’s longer term earnings profile.

    Explore 9 other fair value estimates on Sanofi - why the stock might be worth over 3x more than the current price!

    Build Your Own Sanofi 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 Sanofi research is our analysis highlighting 6 key rewards that could impact your investment decision.
    • Our free Sanofi research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Sanofi'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.