New EU and Japan approvals highlight Sanofi (NASDAQ: SNY) neurology and oncology focus
Rhea-AI Filing Summary
Sanofi filed a Form 6-K summarizing several June 2026 milestones. Japan approved a subcutaneous formulation of Sarclisa for multiple myeloma, including use with standard regimens and potential future administration via an on-body injector, supported by the phase 3 IRAKLIA study showing non-inferior efficacy versus intravenous dosing.
The European Commission approved Cenrifki for adults with secondary progressive multiple sclerosis without recent relapses, based on the HERCULES and GEMINI phase 3 programs, with drug-induced liver injury identified as a key safety risk requiring liver monitoring. Japan also authorized Wayrilz for persistent or chronic immune thrombocytopenia after the LUNA 3 phase 3 study met primary and secondary endpoints.
Separately, Sanofi appointed Paulo Fontoura as Executive Vice President and Global Head of R&D Pharma, effective September 1, 2026, adding an experienced R&D leader to its executive committee.
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Insights
Multiple late-stage approvals in key markets and a new R&D chief strengthen Sanofi’s therapeutic portfolio and leadership bench.
Sanofi reports three major regulatory wins plus an R&D leadership change. Japan cleared subcutaneous Sarclisa for multiple myeloma across newly diagnosed and relapsed settings, with phase 3 data showing a 71.1% objective response rate via on-body injector versus 70.5% for intravenous therapy.
The EU approved Cenrifki for non-relapsing secondary progressive multiple sclerosis, positioning it as a first disability-targeting option for this group. The label highlights drug-induced liver injury risk, so liver monitoring is central to real-world use. In Japan, Wayrilz gained approval for immune thrombocytopenia after LUNA 3 met its endpoints and showed quality-of-life improvements.
On the organizational side, appointing Paulo Fontoura as Executive Vice President, Global Head of R&D Pharma, adds a leader with extensive late-stage development experience across neuroscience, immunology and rare diseases. Subsequent disclosures in company filings may clarify how these approvals and leadership changes translate into revenue and pipeline prioritization.
Key Figures
Key Terms
subcutaneous (SC) formulation medical
on-body injector (OBI) medical
Bruton’s tyrosine kinase inhibitor medical
secondary progressive multiple sclerosis (SPMS) medical
drug-induced liver injury (DILI) medical
orphan drug designation regulatory
FAQ
What does Sanofi (SNY) report in its June 2026 Form 6-K?
What is notable about Sanofi’s Sarclisa subcutaneous approval in Japan?
How does Cenrifki’s EU approval affect Sanofi (SNY) in multiple sclerosis?
What did the LUNA 3 study show for Sanofi’s Wayrilz in immune thrombocytopenia?
Who is Paulo Fontoura and what role will he have at Sanofi (SNY)?
What safety considerations are highlighted for Sanofi’s Cenrifki in the EU?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of June 2026
Commission File Number: 001-31368
SANOFI
(Translation of registrant’s name into English)
46, avenue de la Grande Armée, 75017 Paris, FRANCE
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
1
In June 2026, Sanofi published the press releases attached hereto as Exhibits 99.1, 99.2, 99.3 and 99.4 which are incorporated herein by reference.
Exhibit Index
| Exhibit No. |
Description |
|||
| Exhibit 99.1 | Press Release dated June 19, 2026: Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma. | |||
| Exhibit 99.2 | Press Release dated June 22, 2026: Sanofi appoints Paulo Fontoura as Global Head of R&D. | |||
| Exhibit 99.3 | Press Release dated June 23, 2026: Sanofi’s Cenrifki (tolebrutinib) approved in the EU as the first disability-targeting medicine for secondary progressive multiple sclerosis without relapses | |||
| Exhibit 99.4 | Press Release dated June 23, 2026: Sanofi’s Wayrilz approved in Japan to treat immune thrombocytopenia | |||
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Dated: June 24, 2026 | SANOFI | |||||
| By | /s/ Alexandra Roger | |||||
| Name: Alexandra Roger Title: Head of Legal Corporate & Finance | ||||||
3
Exhibit 99.1
|
Press Release |
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Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma
| • | Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV |
| • | Second global approval for Sarclisa SC following the EU |
Paris, June 19, 2026. The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide and dexamethasone (Pd), or with carfilzomib for the treatment of relapsed or refractory MM (R/R MM) and in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM).
A regulatory submission for the CirCLIQ on-body injector (OBI), based on the enFuse platform and submitted by Enable Injections, is under review in Japan. If approved, Sarclisa SC could become the first anticancer treatment to be administered via an OBI, and the first MM medicine in Japan to offer both manual SC injection and OBI administration.
In recent years, new MM diagnoses have increased steadily in Japan, creating a need for new treatment approaches particularly in the front-line setting. MM is the third most common hematologic malignancy in Japan.
“Today’s approval of Sarclisa subcutaneous represents an important evolution in how we deliver care for multiple myeloma patients in Japan,” said Olivier Nataf, Global Head of Oncology at Sanofi. “This new formulation significantly eases treatment burden and enhances convenience for patients compared to intravenous administration – with the potential to become Japan’s first anticancer therapy to be administered via an on-body injector.”
The approval is based on results from the IRAKLIA phase 3 study in R/R MM (clinical study identifier: NCT05405166), which demonstrated non-inferiority of the SC formulation compared to IV, as well as supportive studies. In addition to manual SC injection, these studies evaluated Sarclisa SC administered through an OBI, and were conducted using Enable Injections’ enFuse hands-free OBI, an automated injector for subcutaneous delivery of Sarclisa.
In the IRAKLIA study, Sarclisa SC administered via an OBI in combination with pomalidomide and dexamethasone (Pd) resulted in a 71.1% objective response rate (ORR), compared to 70.5% with Sarclisa IV-Pd, establishing non-inferiority (risk ratio: 1.008; 95% confidence interval: 0.903-1.126; p=0.0006), in adult patients with R/R MM who had received at least one prior line of treatment. The overall safety profile of Sarclisa SC-Pd observed in this study was consistent with the established safety profile of Sarclisa IV-Pd. While 25% of patients treated with Sarclisa IV-Pd experienced infusion reactions, 1.5% of patients treated with Sarclisa SC-Pd experienced those reactions. No new safety concerns were observed, except for low-grade local injection site reactions (ISRs) that occurred in 0.4% of OBI injections (n=19/5,145 injections). Nearly all ISRs were grade 1, except for one episode of grade 2.
The most common grade ≥3 non hematologic adverse events were pneumonia (14.8% OBI, 15.5% IV), COVID-19 (2.7%, 1.9%), and upper respiratory tract infection (1.5% both arms). The most common grade ≥3 hematologic laboratory abnormalities were neutropenia (84.7% OBI, 74.3% IV), thrombocytopenia (26.1%, 23%), and anemia (17.6%, 19.5%).
In Japan, Sarclisa IV is currently approved across five indications, including in combination with VRd in NDMM, as well as four different treatment regimens in R/R MM (in combination with Pd, in combination with carfilzomib and dexamethasone (Kd), in combination with dexamethasone alone, or as a monotherapy). Sarclisa SC administered via both the CirCLIQ OBI and manual injection was approved in the EU for the treatment of MM patients across all currently approved indications and combinations for Sarclisa IV formulation in June 2026. An application for Sarclisa SC administered via both OBI and manual injection is currently under review in the US.
About the IRAKLIA study
IRAKLIA (clinical study identifier: NCT05405166) was a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa administered at a fixed dose SC via OBI versus weight-based dosed Sarclisa IV in combination with Pd in adult patients with R/R MM who have received at least one prior line of therapy. The co-primary outcomes assessed were ORR, defined as the proportion of patients with stringent complete response (CR), CR, very good partial response, and partial response according to the 2016 International Myeloma Working Group criteria assessed by Independent Review Committee, and observed Sarclisa mean concentration before dosing (Ctrough) at steady state (pre-dose at cycle 6, dose 1 [C6D1]), defined as observed Sarclisa plasma concentrations.
About Enable Injections
Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse® On-Body Delivery System. An innovative wearable technology, the enFuse system is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information, visit www.enableinjections.com.
About Sarclisa
Sarclisa (isatuximab) has been approved in almost 60 countries across four indications for certain patients with NDMM and R/R MM. Sarclisa-based regimens have been prescribed to treat more than 70,000 patients worldwide.
Sarclisa SC is approved in the EU and the UK in combination with approved standard-of-care regimens for the treatment of patients with MM across all currently approved indications for Sarclisa IV in these countries. It is the first anticancer treatment to be administered through an OBI, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both SC OBI and manual injection administration.
Sarclisa SC is approved in Japan in combination with VRd, for the treatment of adult patients with NDMM, as well as Pd and Kd for the treatment of patients with R/R MM.
At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.
For more information on Sarclisa clinical studies, please visit www.clinicaltrials.gov.
About Sanofi
Sanofi is an R&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 | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com
Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com
Investor Relations
Thomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com
Nina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com
Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yu.li3@sanofi.com
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 regarding the marketing and other potential of the product; regarding potential future events and revenues from the product. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” “attempt,” “target,” “project,” “strategy,” “strive,” “desire,” “predict,” “forecast,” “ambition,” “guideline,” “seek,” “should,” “will,” “goal,” 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, uncertainties and assumptions include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful; 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 uncertainties inherent in research and development, 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, and volatile economic and market conditions, 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 except for enFuse and CirCLIQ.
Exhibit 99.2
|
Press Release |
|
Sanofi appoints Paulo Fontoura as Global Head of R&D
Paris, June 22, 2026. Sanofi today announced the appointment of Paulo Fontoura, MD, PhD, FAAN, as Executive Vice President, Global Head of Research & Development Pharma, effective September 1, 2026. He will be a member of Sanofi’s Executive Committee, based in Paris, and will report to Chief Executive Officer Belén Garijo. As head of R&D Pharma, Paulo will lead Sanofi’s end-to-end innovation engine, spanning research, translational medicine, clinical development, and regulatory affairs, with responsibility for advancing a differentiated pipeline and accelerating the delivery of transformative medicines to patients. Paulo succeeds Dr. Houman Ashrafian, who has decided to pursue an opportunity outside the company.
With more than 25 years of experience spanning academic medicine, translational science, clinical development, and pharmaceutical innovation, Paulo joins Sanofi at an important moment as the company continues to advance its R&D transformation and progress a pipeline of new medicines across multiple therapeutic areas.
A board-certified neurologist and physician-scientist, Paulo has played a leading role in the development of significant medicines across neuroscience, immunology, rare diseases, ophthalmology, and infectious diseases. Most recently, he served as Chief Medical Officer of Xaira Therapeutics, an AI-native biotechnology company focused on transforming drug discovery and development through generative artificial intelligence. Prior to Xaira, he spent more than 15 years at Roche, where he held a series of senior leadership positions culminating as Senior Vice President and Global Head of Clinical Development for Neuroscience, Immunology, Ophthalmology, Infectious and Rare Diseases. During his tenure at Roche, he oversaw a global organization of physicians and clinical scientists and was accountable for managing a broad late-stage portfolio across multiple therapeutic areas. Over the years, his teams contributed to the development of over 60 new molecular entities, across several therapeutic modalities, leading to over 20 FDA and EMA first approvals and line extensions, including multiple breakthrough therapies across neuroscience, rare diseases, immunology and ophthalmology.
“I want to thank Dr. Houman Ashrafian for his contribution to our company over the last three years and I wish him all the best in his next chapter. I am delighted to welcome Paulo to the Executive Team. Paulo is a highly respected R&D leader with a strong track record across research, development, and innovation. His scientific expertise, development experience, and leadership of large-scale innovation organizations will be invaluable as we continue to advance our pipeline and shape the future of R&D at Sanofi,” said Belén Garijo, Chief Executive Officer of Sanofi.
“I am thrilled to join Sanofi at such an exciting moment,” said Paulo Fontoura. “In recent years, Sanofi has established a leadership position in immunology and built strong positions in several other areas of significant unmet medical need, while demonstrating a clear commitment to scientific innovation and AI-powered transformation. I am deeply honored to join the company at this important moment and help Sanofi to expand and transform its pipeline and grow its leadership role in biopharma, and I look forward to working with our talented teams to advance breakthrough medicines for patients around the world.”
Paulo holds an MD and PhD from the New University of Lisbon and completed postdoctoral training in neuroimmunology at Stanford University. He is a Fellow of the American Academy of Neurology and has authored more than 80 peer-reviewed scientific publications.
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About Sanofi
Sanofi is an R&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 | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com
Laura Romby | +33 6 74 16 74 29 | laura.romby@sanofi.com
Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pescheva@sanofi.com
Victor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Investor Relations
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Nina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com
Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com
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,” “attempt,” “target,” “project,” “strategy,” “strive,” “desire,” “predict,” “forecast,” “ambition,” “guideline,” “seek,” “should,” “will,” “goal,” 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.
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Exhibit 99.3
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Press Release |
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Sanofi’s Cenrifki (tolebrutinib) approved in the EU as the first disability-targeting medicine for secondary progressive multiple sclerosis without relapses
| • | Cenrifki represents a significant advancement for people living with SPMS by targeting disability progression |
| • | Approval based on the HERCULES phase 3 study in nrSPMS with supporting data from the GEMINI 1 and 2 phase 3 studies in RMS |
Paris, June 23, 2026. The European Commission has approved Cenrifki (tolebrutinib) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last two years. This follows the positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
The approval is based on results from the HERCULES phase 3 study (clinical study identifier: NCT04411641) in non-relapsing SPMS (nrSPMS), with supporting data from the GEMINI 1 (clinical study identifier: NCT04410978) and GEMINI 2 (clinical study identifier: NCT04410991) phase 3 studies in relapsing multiple sclerosis (RMS). The HERCULES study demonstrated that Cenrifki significantly delayed the onset of disability progression in nrSPMS.
The safety profile of Cenrifki has been consistent across the clinical program. The 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 Cenrifki. Strict adherence to liver monitoring requirements, and prompt management of liver enzyme elevations, are important to mitigate DILI risk.
Sanofi will make Cenrifki commercially available in Germany this year in close collaboration between local medical teams, treating MS specialists and their patients, all supported by the required Risk Management Program and robust Patient Support Program. This reflects Sanofi’s commitment to a careful approach to introducing this innovative, first-in-class medicine for people living with SPMS without relapses.
About secondary progressive multiple sclerosis
SPMS is a debilitating stage of MS where patients experience continuous accumulation of disability, including fatigue, cognitive impairment, mobility difficulties, and loss of independence – often without available treatment options. Across major European economies, the yearly cost of MS-related disability surpasses the average annual income per person. As disability accumulates, many are forced to reduce working hours or leave the workforce entirely — while up to 82% of those living with severe MS rely on informal caregiving, extending the strain far beyond the individual. Addressing disability progression remains one of the most significant unmet needs in MS care.
About HERCULES
HERCULES (clinical study identifier: NCT04411641) was a double-blind, randomized phase 3 clinical study evaluating the efficacy and safety of tolebrutinib in patients with nrSPMS. At baseline, nrSPMS was defined as having a SPMS diagnosis with an expanded disability status scale (EDSS) between 3.0 and 6.5, no clinical relapses for the previous 24 months and documented evidence of disability accumulation in the previous 12 months. Participants were randomized (2:1) to receive either an oral daily dose of tolebrutinib or matching placebo for up to approximately 48 months.
The primary endpoint was six-month confirmed disability progression (CDP) defined as the increase of ≥1.0 point from the baseline EDSS score when the baseline score is ≤5.0, or the increase of ≥0.5 point when the baseline EDSS score was >5.0. Secondary endpoints included time to onset of three-month CDP as assessed by EDSS score, total number of new or enlarging T2 hyperintense lesions as detected by MRI, time to onset of confirmed disability improvement, 3-month change in 9-hole peg test and timed 25-foot walk test, as well as the safety and tolerability of tolebrutinib.
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About GEMINI 1 and 2
GEMINI 1 (clinical study identifier: NCT04410978) and GEMINI 2 (clinical study identifier: NCT04410991) were double-blind, randomized phase 3 clinical studies evaluating the efficacy and safety of tolebrutinib compared to teriflunomide, an oral disease-modifying medicine, in patients with RMS. Participants were randomized in both studies (1:1) to receive either tolebrutinib and placebo daily or 14 mg teriflunomide and placebo.
The primary endpoint for both studies was the annualized relapse rate for up to approximately 36 months defined as the number of confirmed adjudicated protocol defined relapses. Secondary endpoints included time to onset of confirmed disease worsening, confirmed over at least six months, defined as an increase of ≥1.5 points from the baseline EDSS score when the baseline score is 0, an increase of ≥1.0 point from the baseline EDSS score when the baseline score is 0.5 to ≤5.5 or an increase of ≥0.5 point from the baseline EDSS score when the baseline score was >5.5 in addition to the total number of new and/or enlarging T2 hyperintense lesions as detected by MRI from baseline through the end of study, the total number of Gd-enhancing T1 hyperintense lesions as detected by MRI from baseline through the end of study, and the safety and tolerability of tolebrutinib.
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 unique mechanism of action addresses the underlying biology of progressive MS by targeting the inflammatory processes that contribute to disability accumulation. Cenrifki is the first disease-targeting therapy designed to address the underlying process of MS disability accumulation approved in the EU for adults with SPMS without relapses in the last two years.
Cenrifki is administered once daily with a meal, and treatment should be initiated and supervised by a physician experienced in the management of multiple sclerosis.
Cenrifki is also approved in Australia for the treatment of nrSPMS and to slow disability accumulation in the absence of relapse activity with SPMS and in the United Arab Emirates for the treatment of SPMS without relapses in the last two years.
Cenrifki represents Sanofi’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 neuro-inflammatory and neuro-degenerative 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&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
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Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com
Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com
Laura Romby | +33 6 74 16 74 29 | laura.romby@sanofi.com
Investor Relations
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Nina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com
Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com
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 regarding the marketing and other potential of the product; regarding potential future events and revenues from the product. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” “attempt,” “target,” “project,” “strategy,” “strive,” “desire,” “predict,” “forecast,” “ambition,” “guideline,” “seek,” “should,” “will,” “goal,” 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, uncertainties and assumptions include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful; 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 uncertainties inherent in research and development, 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, and volatile economic and market conditions, 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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Exhibit 99.4
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Press Release |
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Sanofi’s Wayrilz approved in Japan to treat immune thrombocytopenia
| • | Wayrilz is a BTK inhibitor that works through multi-immune modulation to help address the underlying causes of immune thrombocytopenia (ITP) |
| • | Approval based on the LUNA 3 phase 3 study that demonstrated rapid and durable platelet response and improvements in other symptoms |
| • | ITP is a rare disease of complex immune dysregulation leading to lower platelet counts, bleeding, and reduced quality of life |
Paris, June 23, 2026. The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization to Wayrilz (rilzabrutinib), a novel oral reversible Bruton’s tyrosine kinase inhibitor (BTKi), for the treatment of persistent or chronic immune thrombocytopenia (ITP) in patients who do not respond sufficiently to other treatments or in whom tolerability is considered to be problematic. Wayrilz can help address the underlying causes of the disease, through multi-immune modulation, targeting key pathways across the immune system.
The approval is based on the LUNA 3 phase 3 study (clinical study identifier: NCT04562766), in which Wayrilz met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other symptoms.
“For ITP patients, achieving platelet counts close to normal and living without worrying about bleeding is extremely important. Additionally, in recent years, there has been growing interest in various other symptoms associated with ITP such as fatigue,” said Hisashi Kato, MD, PhD, Department of Blood Transfusion and Cell Therapy, The University of Osaka Hospital, Suita, Japan. “Wayrilz is a novel BTKi that works through multi-immune modulation to help address the root cause of ITP pathophysiology. It is expected to become a new therapeutic option that may help patients with disease management, including not only improvement in platelet counts but also considering patients’ quality of life.”
“People living with immune thrombocytopenia who continue to experience symptoms, despite trying existing treatments, face a great unmet need,” said Manuela Buxo, Executive Vice President, Global Head of Specialty Care at Sanofi. “Wayrilz has a differentiated mechanism of action that enables multi-immune modulation to address the underlying pathophysiology of ITP and offers new hope to patients who have not responded to prior therapy. This milestone underscores Sanofi’s commitment to bringing innovative treatment options to rare disease patients around the world.”
The LUNA 3 phase 3 study evaluated the efficacy and safety of Wayrilz compared to placebo in adults (n=202) with persistent or chronic ITP. Patients who achieved platelet count response at 12 weeks were eligible to continue the full 24-week double-blind period (64% of patients in the Wayrilz arm and 32% of patients in the placebo arm). Patients receiving Wayrilz experienced the following compared to patients receiving placebo:
| • | Statistically significant durable platelet response at week 25 (23% of patients in Wayrilz arm vs. 0% in placebo arm; p<0.0001) |
| • | Faster time to first platelet response (36 days in Wayrilz arm vs. not reached in placebo arm; p<0.0001) |
| • | Longer duration of platelet response (least square mean of 7 weeks in Wayrilz arm vs. 0.7 weeks in placebo arm) |
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Patients receiving Wayrilz reported an overall 10.6-point improvement in the overall quality of life domain compared to a 2.3-point increase in the placebo arm, based on The Immune Thrombocytopenia Patient Assessment Questionnaire, a clinical tool designed to measure ITP symptoms and impacts. The results of this analysis are descriptive and were not powered for statistical significance.
The most common adverse reactions (incidence ≥10%) were diarrhea, nausea, headache, abdominal pain, and COVID-19.
Wayrilz is being studied across multiple other rare diseases, including IgG4-related disease (IgG4-RD), warm autoimmune hemolytic anemia (wAIHA), and sickle cell disease. These additional indications are currently under investigation and have not been approved by regulatory authorities. Japan has granted Wayrilz orphan drug designation for ITP, IgG4-RD, and wAIHA.
About ITP
ITP is a disease of complex immune dysregulation that causes low platelet counts (<100,000/µL), resulting in a variety of bleeding symptoms and high risk of thromboembolism. Beyond bruising and bleeding, which can include potentially life-threatening episodes like intracranial hemorrhage, people living with ITP may experience reduced quality of life, including physical fatigue and cognitive impairment.
About Wayrilz
Wayrilz (rilzabrutinib) is a novel oral reversible covalent BTK inhibitor that has the potential to be an effective new medicine for several rare immune-mediated or inflammatory diseases by working to restore immune balance via multi-immune modulation. The enzyme BTK, expressed in B cells, macrophages, and other innate immune cells, plays a critical role in multiple immune-mediated disease processes and inflammatory pathways. With the application of the TAILORED COVALENCY® technology, Wayrilz can selectively inhibit the BTK target. Wayrilz is now approved for the treatment of ITP in the US, the EU, the UAE, the UK and Japan.
About Sanofi
Sanofi is an R&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 | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com
Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com
Laura Romby | +33 6 74 16 74 29 | laura.romby@sanofi.com
Investor Relations
Thomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com
Nina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com
Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com
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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 regarding the marketing and other potential of the product; regarding potential future events and revenues from the product. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” “attempt,” “target,” “project,” “strategy,” “strive,” “desire,” “predict,” “forecast,” “ambition,” “guideline,” “seek,” “should,” “will,” “goal,” 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, uncertainties and assumptions include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful; 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 uncertainties inherent in research and development, 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, and volatile economic and market conditions, 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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