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EU Clears SNY's Cenrifki for Secondary Progressive Multiple Sclerosis
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Key Takeaways
Sanofi's Cenrifki won EU approval for adults with SPMS who had no relapses in the past two years.
Cenrifki became the first disability-targeting medicine approved in the EU for non-relapsing SPMS.
Sanofi also secured Japan approval for Wayrilz in chronic or persistent ITP based on phase III data.
Sanofi (SNY - Free Report) announced that the European Commission has approved its Bruton's tyrosine kinase (BTK) inhibitor, Cenrifki (tolebrutinib), for treating secondary progressive multiple sclerosis (SPMS) in adult patients who have not experienced relapses in the past two years.
Following the nod, Cenrifki became the first disability-targeting medicine to be approved for SPMS without relapses in the EU.
Sanofi will launch Cenrifki in Germany later this year, with the required support programs in place. The company aims to ensure a careful rollout of this innovative, first-in-class treatment for SPMS without relapses.
More on SNY’s Cenrifki EU Approval
The latest EU nod was based on data from the phase III HERCULES study, which evaluated Cenrifki in non-relapsing SPMS (nrSPMS), as well as supporting data from the phase III GEMINI 1 and GEMINI 2 studies, which investigated Cenrifki in relapsing multiple sclerosis.
Data from the HERCULES study showed that treatment with Cenrifki significantly delayed the onset of disability progression in nrSPMS.
The safety profile of Cenrifki has remained consistent throughout its clinical development program.
The approval in the EU was expected, as in April 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use rendered a positive opinion recommending approval of Cenrifki for treating SPMS without relapses.
We remind investors that the FDA issued a complete response letter to Sanofi’s regulatory application seeking approval of tolebrutinib in non-relapsing secondary progressive multiple sclerosis in December 2025.
SNY’s Price Performance
Year to date, shares of Sanofi have declined 10.3% against the industry’s increase of 2.7%.
Image Source: Zacks Investment Research
SNY’s Wayrilz Gets Approval in Japan
In a separate press release, Sanofi announced that the Ministry of Health, Labour and Welfare in Japan has approved Wayrilz (rilzabrutinib), a novel BTK inhibitor, for treating persistent or chronic immune thrombocytopenia (ITP) in patients who do not respond sufficiently to existing therapies or who experience tolerability issues.
The approval in Japan was based on data from the pivotal phase III LUNA 3 study, which showed that treatment with Wayrilz led to a positive impact on sustained platelet counts and other ITP symptoms, thus meeting both the primary and secondary endpoints.
Wayrilz was approved for the treatment of ITP in the United States in August 2025 and in the EU in December 2025.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR stock has lost 15.4% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 118.9% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
View the Zacks #1 Rank List
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EU Clears SNY's Cenrifki for Secondary Progressive Multiple Sclerosis
Key Takeaways
Sanofi (SNY - Free Report) announced that the European Commission has approved its Bruton's tyrosine kinase (BTK) inhibitor, Cenrifki (tolebrutinib), for treating secondary progressive multiple sclerosis (SPMS) in adult patients who have not experienced relapses in the past two years.
Following the nod, Cenrifki became the first disability-targeting medicine to be approved for SPMS without relapses in the EU.
Sanofi will launch Cenrifki in Germany later this year, with the required support programs in place. The company aims to ensure a careful rollout of this innovative, first-in-class treatment for SPMS without relapses.
More on SNY’s Cenrifki EU Approval
The latest EU nod was based on data from the phase III HERCULES study, which evaluated Cenrifki in non-relapsing SPMS (nrSPMS), as well as supporting data from the phase III GEMINI 1 and GEMINI 2 studies, which investigated Cenrifki in relapsing multiple sclerosis.
Data from the HERCULES study showed that treatment with Cenrifki significantly delayed the onset of disability progression in nrSPMS.
The safety profile of Cenrifki has remained consistent throughout its clinical development program.
The approval in the EU was expected, as in April 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use rendered a positive opinion recommending approval of Cenrifki for treating SPMS without relapses.
We remind investors that the FDA issued a complete response letter to Sanofi’s regulatory application seeking approval of tolebrutinib in non-relapsing secondary progressive multiple sclerosis in December 2025.
SNY’s Price Performance
Year to date, shares of Sanofi have declined 10.3% against the industry’s increase of 2.7%.
Image Source: Zacks Investment Research
SNY’s Wayrilz Gets Approval in Japan
In a separate press release, Sanofi announced that the Ministry of Health, Labour and Welfare in Japan has approved Wayrilz (rilzabrutinib), a novel BTK inhibitor, for treating persistent or chronic immune thrombocytopenia (ITP) in patients who do not respond sufficiently to existing therapies or who experience tolerability issues.
The approval in Japan was based on data from the pivotal phase III LUNA 3 study, which showed that treatment with Wayrilz led to a positive impact on sustained platelet counts and other ITP symptoms, thus meeting both the primary and secondary endpoints.
Wayrilz was approved for the treatment of ITP in the United States in August 2025 and in the EU in December 2025.
SNY's Zacks & Stocks to Consider
Sanofi currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR stock has lost 15.4% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 118.9% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.