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Sanofi Wins Positive EU CHMP Opinion for Rezurock in Chronic Graft-Versus-Host Disease

Tipranks - Sat Feb 7, 9:38AM CST

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Sanofi ( (SNY) ) has shared an announcement.

On January 30, 2026, Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending conditional EU marketing authorization for Rezurock (belumosudil) to treat adults and adolescents aged 12 and older with chronic graft-versus-host disease who have limited remaining treatment options. The recommendation, which reverses a negative CHMP opinion from October 2025 following Sanofi’s request for re-examination, is based on a body of clinical and real‑world evidence, including the pivotal ROCKstar phase 2 trial showing a 74% overall response rate and generally manageable safety, and would require Sanofi to run a new randomized confirmatory study. Rezurock is already approved in 20 countries, where more than 17,000 patients have been treated since 2021; an eventual EU authorization would expand Sanofi’s presence in the rare hematologic disease segment, strengthen its late‑line GVHD franchise, and potentially improve outcomes for a substantial subset of stem cell transplant recipients for whom chronic GVHD remains a major cause of morbidity and mortality.

The most recent analyst rating on (SNY) stock is a Hold with a $51.00 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.

The score is driven primarily by solid financial resilience and a constructive earnings outlook (growth, margin expansion, and buybacks). Valuation is supportive with a reasonable P/E and strong dividend, while weaker technical trend signals (below major moving averages and negative MACD) temper the overall rating.

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

More about Sanofi

Sanofi is an R&D-driven, AI-powered biopharmaceutical company that develops medicines and vaccines, applying its expertise in immunology to treat and protect millions of patients worldwide. Listed on Euronext Paris and Nasdaq, the group targets high unmet medical needs with an innovative pipeline aimed at delivering both therapeutic advances and long-term growth in global healthcare markets.

Average Trading Volume: 2,929,757

Technical Sentiment Signal: Hold

Current Market Cap: $116.8B

Find detailed analytics on SNY stock on TipRanks’ Stock Analysis page.

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