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Sanofi Gets EU Nod for Rezurock in Chronic Graft-Vs-Host Disease
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Key Takeaways
SNY won EU conditional approval for Rezurock to treat chronic GVHD in patients aged 12 years and above.
Sanofi's approval is backed by the ROCKstar study showing durable responses and a good safety profile.
Sanofi reported Rezurock sales rose 8.7% Y/Y in 2025, with EU nod expected to drive further growth.
Sanofi (SNY - Free Report) announced that the European Commission has granted a conditional marketing authorization to Rezurock (belumosudil) for treating chronic graft-versus-host disease (GVHD) in adults and in children aged 12 years and above weighing at least 40 kg.
This conditional approval is contingent on completion of a confirmatory, randomized, controlled study. Rezurock is to be used when other treatments offer limited benefit, aren’t suitable, or have been exhausted.
The approval in the EU was expected, as in January 2026, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion, recommending the conditional marketing authorization of Rezurock for the given indication.
SNY’s Price Performance
Year to date, shares of Sanofi have declined 3.8% compared with the industry’s decrease of 4.7%.
Image Source: Zacks Investment Research
More on the EU Nod for SNY’s Rezurock
The approval of Rezurock in the EU was based on safety and efficacy data from various clinical studies and real-world evidence, including data from the phase II ROCKstar study.
Data from the ROCKstar study showed that treatment with Rezurock led to clinically meaningful and durable responses in patients living with chronic GVHD after stem cell transplant and at least two prior lines of systemic therapy.
Treatment with Rezurock was generally safe and well-tolerated.
Rezurock is currently approved in 20 countries, including the United States, United Kingdom, and Canada, to treat patients with chronic GVHD after at least two prior therapies have failed, and in China after one prior therapy.
Rezurock was added to Sanofi’s commercial portfolio following the acquisition of Kadmon Holdings in 2021. The drug recorded sales worth €490 million in 2025, up 8.7% year over year, on a constant currency rate basis.
The approval for Rezurock in the EU should drive sales further in 2026.
Sanofi is also evaluating the safety and efficacy of Rezurock in other age groups and indications, including ongoing studies for pediatric patients with chronic GVHD from one year old having received at least two prior lines of systemic therapy and patients with chronic lung allograft dysfunction.
Over the past 60 days, estimates for Prothena’s 2026 earnings per share have increased from 20 cents to 36 cents, while loss per share estimates for 2027 have narrowed from $1.20 to 98 cents. PRTA’s shares have decreased 3.2% year to date.
Prothena’s earnings beat estimates in one of the trailing four quarters and missed on the remaining three occasions, with the average negative surprise being 24.69%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.28 to $8.99, while the same for 2027 have increased from $9.25 to $10.10. ANIP’s shares have fallen 6.6% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased from 63 cents to $1.75, while the same for 2027 have increased from $1.55 to $2.91. LQDA’s shares have risen 2% year to date
Liquidia’s earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, with the average surprise being 39.38%.
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Sanofi Gets EU Nod for Rezurock in Chronic Graft-Vs-Host Disease
Key Takeaways
Sanofi (SNY - Free Report) announced that the European Commission has granted a conditional marketing authorization to Rezurock (belumosudil) for treating chronic graft-versus-host disease (GVHD) in adults and in children aged 12 years and above weighing at least 40 kg.
This conditional approval is contingent on completion of a confirmatory, randomized, controlled study. Rezurock is to be used when other treatments offer limited benefit, aren’t suitable, or have been exhausted.
The approval in the EU was expected, as in January 2026, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion, recommending the conditional marketing authorization of Rezurock for the given indication.
SNY’s Price Performance
Year to date, shares of Sanofi have declined 3.8% compared with the industry’s decrease of 4.7%.
Image Source: Zacks Investment Research
More on the EU Nod for SNY’s Rezurock
The approval of Rezurock in the EU was based on safety and efficacy data from various clinical studies and real-world evidence, including data from the phase II ROCKstar study.
Data from the ROCKstar study showed that treatment with Rezurock led to clinically meaningful and durable responses in patients living with chronic GVHD after stem cell transplant and at least two prior lines of systemic therapy.
Treatment with Rezurock was generally safe and well-tolerated.
Rezurock is currently approved in 20 countries, including the United States, United Kingdom, and Canada, to treat patients with chronic GVHD after at least two prior therapies have failed, and in China after one prior therapy.
Rezurock was added to Sanofi’s commercial portfolio following the acquisition of Kadmon Holdings in 2021. The drug recorded sales worth €490 million in 2025, up 8.7% year over year, on a constant currency rate basis.
The approval for Rezurock in the EU should drive sales further in 2026.
Sanofi is also evaluating the safety and efficacy of Rezurock in other age groups and indications, including ongoing studies for pediatric patients with chronic GVHD from one year old having received at least two prior lines of systemic therapy and patients with chronic lung allograft dysfunction.
SNY’s Zacks Rank & Stocks to Consider
Sanofi currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Prothena (PRTA - Free Report) , ANI Pharmaceuticals (ANIP - Free Report) and Liquidia Corporation (LQDA - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for Prothena’s 2026 earnings per share have increased from 20 cents to 36 cents, while loss per share estimates for 2027 have narrowed from $1.20 to 98 cents. PRTA’s shares have decreased 3.2% year to date.
Prothena’s earnings beat estimates in one of the trailing four quarters and missed on the remaining three occasions, with the average negative surprise being 24.69%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.28 to $8.99, while the same for 2027 have increased from $9.25 to $10.10. ANIP’s shares have fallen 6.6% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased from 63 cents to $1.75, while the same for 2027 have increased from $1.55 to $2.91. LQDA’s shares have risen 2% year to date
Liquidia’s earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, with the average surprise being 39.38%.