The Bull Case For Sanofi (ENXTPA:SAN) Could Change Following FDA Priority Review Of Tzield Expansion

• In recent days, the US FDA accepted a priority review of Sanofi’s supplemental application for Tzield, aiming to extend its use to children aged one year and older with stage 2 type 1 diabetes, supported by interim PETITE-T1D Phase 4 data and a target decision date of April 29, 2026.
• This accelerated review could meaningfully broaden Tzield’s eligible pediatric population, underscoring Sanofi’s efforts to address early-stage autoimmune disease in very young patients.
• We’ll now examine how this potential expansion of Tzield’s reach into younger children could influence Sanofi’s investment narrative and long-term positioning.

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Sanofi Investment Narrative Recap

To own Sanofi, you need to believe in a diversified, innovation-focused pharma business that can offset pricing and patent pressures with successful new therapies in immunology and specialty care. The Tzield pediatric expansion review and the Earendil collaboration both lean into that story, but they do not change that the key near term swing factor remains execution across the broader pipeline, while pricing pressure in vaccines and eventual Dupixent patent expiry stay front of mind as major risks.

Among recent updates, the new Earendil Labs collaboration on bispecific antibodies in autoimmune and inflammatory diseases is particularly relevant, as it reinforces Sanofi’s push to refresh and deepen its immunology portfolio. Together with Tzield’s potential label expansion, it speaks directly to the company’s effort to build future growth pillars that can help offset pricing headwinds and longer term patent expiries if the underlying science translates into successful products.

However, investors should also be aware that despite these developments, regulatory uncertainty around key late stage assets could still...

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

Sanofi's narrative projects €51.8 billion revenue and €9.6 billion earnings by 2028.

Uncover how Sanofi's forecasts yield a €104.87 fair value, a 27% upside to its current price.

Exploring Other Perspectives

Eight members of the Simply Wall St Community currently see Sanofi’s fair value between €91 and about €304 per share, highlighting wide dispersion in expectations. You are weighing those views against execution risk in Sanofi’s pipeline, which could influence how effectively new immunology assets offset pricing and patent pressures over time.

Explore 8 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.

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