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Sanofi’s Wayrilz Gains FDA Approval as First BTK Inhibitor for ITP

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Sanofi’s Wayrilz Gains FDA Approval as First BTK Inhibitor for ITP

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Sanofi ( (SNY) ) has issued an announcement.

On August 29, 2025, Sanofi announced that the US FDA approved Wayrilz (rilzabrutinib) as the first Bruton’s tyrosine kinase (BTK) inhibitor for adults with persistent or chronic immune thrombocytopenia (ITP) who have not responded to previous treatments. This approval, based on the LUNA 3 phase 3 study, highlights Wayrilz’s potential to improve platelet counts and quality of life for over 25,000 US adults with ITP. The approval underscores Sanofi’s expertise in rare and immunological diseases, potentially positioning Wayrilz as a treatment of choice for ITP, enhancing Sanofi’s market presence in the field of rare blood disorders.

The most recent analyst rating on (SNY) stock is a Buy with a $56.00 price target. To see the full list of analyst forecasts on Sanofi stock, see the SNY Stock Forecast page.

Spark’s Take on SNY Stock

According to Spark, TipRanks’ AI Analyst, SNY is a Outperform.

Sanofi’s overall stock score is driven by strong earnings call performance and attractive valuation. Financial stability is evident, though cash flow concerns and slight revenue growth challenges are noted. Technical analysis suggests neutral momentum, supporting a balanced outlook.

To see Spark’s full report on SNY stock, click here.

More about Sanofi

Sanofi is a research and development-driven, AI-powered biopharmaceutical company focused on improving lives through innovative medicines and vaccines. The company leverages its deep understanding of the immune system to create treatments that address urgent healthcare challenges globally. Sanofi is publicly traded on EURONEXT and NASDAQ.

Average Trading Volume: 2,209,332

Technical Sentiment Signal: Buy

Current Market Cap: $120.1B

Learn more about SNY stock on TipRanks’ Stock Analysis page.

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