Sanofi&#39;s Cenrifki (tolebrutinib) recommended for EU approval by the CHMP to treat secondary progressive multiple sclerosis without relapses  Recommendation based on the HERCULES phase 3 study which demonstrated that

PARIS:SAN

Press Release: Sanofi's Cenrifki (tolebrutinib) recommended for EU approval by the CHMP to treat secondary progressive multiple sclerosis without relapses

Sanofi's Cenrifki Receives Positive EU Recommendation for MS Treatment

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 <section data-block="information">
 <h3>Information</h3>
 Sanofi&amp;#39;s Cenrifki (tolebrutinib) recommended for EU approval by the CHMP to treat secondary progressive multiple sclerosis without relapses Recommendation based on the HERCULES phase 3 study which demonstrated that
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 <section data-block="ai-summary-paragraph">
 <h3>AI Summary</h3>
 The European Medicines Agency&#039;s CHMP has recommended Sanofi&#039;s Cenrifki (tolebrutinib) for the treatment of secondary progressive multiple sclerosis (SPMS). This potential approval could address a significant market gap and enhance Sanofi&#039;s therapeutic portfolio, boosting investor sentiment.
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 <h3>Key Points</h3>
 <ul><li>Sanofi&#039;s Cenrifki recommended for EU approval for SPMS treatment.</li><li>Approval based on HERCULES study delaying disability progression.</li><li>Final decision from EMA expected in upcoming months.</li><li>Cenrifki addresses significant unmet need in MS care.</li><li>Safety concerns include drug-induced liver injury risks.</li></ul>
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 <section data-block="companies-mentioned">
 <h3>Companies Mentioned</h3>
 <ul><li>Sanofi (SAN): Increased focus on its innovative neurology treatments could drive stock performance.</li></ul>
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 <section data-block="category">
 <h3>Corporate Developments</h3>
 This news fits under &#039;Corporate Developments&#039; as it pertains to Sanofi&#039;s drug approval process, which highlights their strategic initiatives in addressing critical healthcare needs and informs potential investors about future revenue streams.
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 <section data-block="market-moving">
 <h3>Market-Moving</h3>
 <ul><li>Cenrifki&#039;s approval could enhance Sanofi&#039;s market presence in neurology.</li><li>Positive EMAs have historically led to stock price increases for biopharma firms.</li><li>Reported safety risks may prompt investor caution.</li></ul>
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 <section data-block="key-facts">
 <h3>Key Facts</h3>
 <ul><li>Cenrifki targets secondary progressive multiple sclerosis (SPMS) without relapses.</li><li>Positive recommendation based on data from the HERCULES study.</li><li>Final EMA decision expected in upcoming months.</li><li>Cenrifki&#039;s safety profile includes potential for drug-induced liver injury.</li><li>Sanofi&#039;s neurology pipeline includes various phase 3 projects.</li></ul>
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 <section data-block="trading-thesis">
 <h3>Trading Thesis</h3>
 Consider buying PARIS:SAN shares ahead of anticipated EU approval news.
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<link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css"></link>Sanofi's Cenrifki (tolebrutinib) recommended for EU approval by the CHMP to treat secondary progressive multiple sclerosis without relapses <ul type="disc"><li style="text-align:left;">Recommendation based on the HERCULES phase 3 study which demonstrated that brain-penetrant Cenrifki (tolebrutinib) significantly delayed the onset of disability progression in non-relapsing SPMS </li></ul> Paris, April 24, 2026. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Cenrifki (tolebrutinib) in the EU for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last two years. A final decision is expected in the coming months. SPMS is a debilitating stage of multiple sclerosis where patients experience continuous accumulation of disability, including fatigue, cognitive impairment, mobility difficulties, and loss of independence – often without available treatment options. Addressing disability progression remains one of the most significant unmet needs in MS care. The positive CHMP opinion is based on data from the HERCULES phase 3 study (clinical study identifier: <a href="https://clinicaltrials.gov/study/NCT04411641" rel="nofollow" target="_blank">NCT04411641</a>) in non-relapsing SPMS, with supporting data from the GEMINI 1 (clinical study identifier: <a href="https://www.clinicaltrials.gov/study/NCT04410978?term=NCT04410978%20&amp;rank=1" rel="nofollow" target="_blank">NCT04410978</a>) and GEMINI 2 (clinical study identifier: <a href="https://www.clinicaltrials.gov/study/NCT04410991?term=NCT04410991&amp;rank=1" rel="nofollow" target="_blank">NCT04410991</a>) phase 3 studies in relapsing multiple sclerosis (RMS), which were presented at the <a href="https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-20-09-30-00-2949552" rel="nofollow" target="_blank">European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Conference 2024</a>, the American Academy of Neurology (AAN) 2025 Annual Meeting, and published in <a href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-08-17-11-11-3057931" rel="nofollow" target="_blank">The New England Journal of Medicine</a>. The safety profile of Cenrifki has been consistent across the clinical program. Most common adverse events were COVID-19 and upper respiratory tract infections. Significant liver enzyme elevations were also observed. Drug-induced liver injury (DILI) is an identified safety risk of tolebrutinib. Strict adherence to liver monitoring requirements, and prompt management of liver enzyme elevations, are important to mitigate DILI risk. Additional submissions for Cenrifki are currently under review with regulatory authorities worldwide. About Cenrifki Cenrifki (tolebrutinib) is an oral, brain-penetrant Bruton's tyrosine kinase inhibitor specifically designed to target smoldering neuroinflammation, a key driver of disability progression in MS. This mechanism addresses the underlying pathology of secondary progressive MS by targeting the inflammatory processes that contribute to disability accumulation. Cenrifki represents Sanofi&#39;s commitment to developing innovative treatments that address the underlying causes of neurological diseases and potentially transform the treatment landscape. Standing at the intersection of neurology and immunoscience, Sanofi is focused on improving the lives of those living with serious neuroinflammatory and neurodegenerative conditions including MS, chronic inflammatory demyelinating polyneuropathy, Alzheimer's disease, Parkinson's disease, age-related macular degeneration, and other neurological diseases. The neurology pipeline currently has several projects in phase 3 studies across various diseases. About Sanofi Sanofi is an R&amp;D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Sandrine Guendoul &#x7C; +33 6 25 09 14 25 &#x7C; <a href="mailto:sandrine.guendoul@sanofi.com" rel="nofollow" target="_blank">sandrine.guendoul@sanofi.com</a> Evan Berland &#x7C; +1 215 432 0234 &#x7C; <a href="mailto:evan.berland@sanofi.com" rel="nofollow" target="_blank">evan.berland@sanofi.com</a>   Léo Le Bourhis &#x7C; +33 6 75 06 43 81 &#x7C; <a href="mailto:leo.lebourhis@sanofi.com" rel="nofollow" target="_blank">leo.lebourhis@sanofi.com</a>   Victor Rouault &#x7C; +1 617 356 4751 &#x7C; <a href="mailto:victor.rouault@sanofi.com" rel="nofollow" target="_blank">victor.rouault@sanofi.com</a> Timothy Gilbert &#x7C; +1 516 521 2929 &#x7C; <a href="mailto:timothy.gilbert@sanofi.com" rel="nofollow" target="_blank">timothy.gilbert@sanofi.com</a> Léa Ubaldi &#x7C; +33 6 30 19 66 46 &#x7C; <a href="mailto:lea.ubaldi@sanofi.com" rel="nofollow" target="_blank">lea.ubaldi@sanofi.com</a> Ekaterina Pesheva &#x7C; +1 410 926 6780 &#x7C; ekaterina.pescheva@sanofi.com Investor Relations Thomas Kudsk Larsen &#x7C;+ 44 7545 513 693 &#x7C; <a href="mailto:thomas.larsen@sanofi.com" rel="nofollow" target="_blank">thomas.larsen@sanofi.com</a> Alizé Kaisserian &#x7C; + 33 6 47 04 12 11 &#x7C; <a href="mailto:alize.kaisserian@sanofi.com" rel="nofollow" target="_blank">alize.kaisserian@sanofi.com</a> Keita Browne &#x7C; + 1 781 249 1766 &#x7C; <a href="mailto:keita.browne@sanofi.com" rel="nofollow" target="_blank">keita.browne@sanofi.com</a> Nathalie Pham &#x7C; + 33 7 85 93 30 17 &#x7C; <a href="mailto:nathalie.pham@sanofi.com" rel="nofollow" target="_blank">nathalie.pham@sanofi.com</a> Nina Goworek &#x7C; +1 908 569 7086 &#x7C; <a href="mailto:nina.goworek@sanofi.com" rel="nofollow" target="_blank">nina.goworek@sanofi.com</a> Thibaud Châtelet &#x7C; + 33 6 80 80 89 90 &#x7C; <a href="mailto:thibaud.chatelet@sanofi.com" rel="nofollow" target="_blank">thibaud.chatelet@sanofi.com</a> Yun Li &#x7C; +33 6 84 00 90 72 &#x7C; <a href="mailto:yun.li3@sanofi.com" rel="nofollow" target="_blank">yun.li3@sanofi.com</a> Sanofi Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future events and economic performance. Words such as "expect," "anticipate," "believe," "intend," "estimate," "plan," "can," "contemplate," "could," "is designed to," "may," "might," "potential," "objective," &#34;attempt,&#34; "target," "project," &#34;strategy,&#34; &#34;strive,&#34; &#34;desire,&#34; "predict," "forecast," "ambition," "guideline," &#34;seek,&#34; "should," "will," &#34;goal,&#34; or the negative of these, and similar expressions are intended to identify forward-looking statements. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the U.S Food and Drug Administration or the European Medicines Agency, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates; the fact that product candidates if approved may not be commercially successful; unexpected regulatory actions or delays, or government regulation generally; authorities' decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including "most favored nation" pricing for State Medicaid programs; the future approval and commercial success of therapeutic alternatives; Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation;  trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markets Authority (AMF) made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein. All trademarks mentioned in this press release are the property of the Sanofi group.  
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The European Medicines Agency's CHMP has recommended Sanofi's Cenrifki (tolebrutinib) for the treatment of secondary progressive multiple sclerosis (SPMS). This potential approval could address a significant market gap and enhance Sanofi's therapeutic portfolio, boosting investor sentiment.

press-release-sanofi-s-cenrifki-tolebrutinib-recommended-for-eu-approval-by-the-chmp-to-treat-secondary-progressive-multiple-sclerosis-without-relapses

Press Release: Sanofi's Cenrifki (tolebrutinib) recommended for EU approval by the CHMP to treat secondary progressive multiple sclerosis without relapses

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