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Sanofi’s Rilzabrutinib Gains EU Orphan Designation for IgG4-Related Disease

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Sanofi’s Rilzabrutinib Gains EU Orphan Designation for IgG4-Related Disease

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The latest announcement is out from Sanofi ( (SNY) ).

On August 14, 2025, Sanofi announced that its investigational drug rilzabrutinib received orphan designation from the European Medicines Agency for treating IgG4-related disease, a rare immune-mediated condition. This designation highlights Sanofi’s commitment to advancing treatments for rare diseases. The drug, which showed positive results in a Phase 2 study, is also under regulatory review in the US, EU, and China for immune thrombocytopenia, with a US FDA decision expected by August 29, 2025.

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 and profitability support the score, although cash flow challenges and mixed technical indicators present some risks. The company’s strategic focus and positive guidance contribute to a favorable outlook.

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

More about Sanofi

Sanofi is an R&D driven, AI-powered biopharma company focused on improving lives through innovative medicines and vaccines. With a deep understanding of the immune system, Sanofi aims to address urgent healthcare, environmental, and societal challenges. The company is listed on EURONEXT and NASDAQ.

Average Trading Volume: 2,264,018

Technical Sentiment Signal: Strong Buy

Current Market Cap: $121.3B

See more data about SNY stock on TipRanks’ Stock Analysis page.

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