[6-K] Sanofi Current Report (Foreign Issuer)
Rhea-AI Filing Summary
Sanofi filed a Form 6-K summarizing three March 2026 updates. Japan’s Ministry of Health, Labour and Welfare granted orphan drug designation to rilzabrutinib, an oral BTK inhibitor, for IgG4-related disease after phase 2 data showed reduced disease flares, improved markers and lower glucocorticoid use, with a safety profile consistent with earlier studies. Rilzabrutinib is approved for immune thrombocytopenia in the US, EU and UAE and is in a phase 3 IgG4-RD study. Sanofi also filed an amendment to its French “Document d’Enregistrement Universel” containing the Annual Financial Report, adding corporate governance information. The Board will ask shareholders on April 29, 2026 to appoint Christel Heydemann as an independent director, renew the mandates of Christophe Babule and Jean‑Paul Kress, and notes that Patrick Kron will leave the Board, which would remain at 16 members and 57% women excluding employee representatives.
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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 March 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 ☐
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In March 2026, Sanofi published the press releases attached hereto as Exhibits 99.1, 99.2 and 99.3 which are incorporated herein by reference.
Exhibit Index
| Exhibit No. |
Description | |
| Exhibit 99.1 | Press Release dated March 2, 2026: Sanofi’s rilzabrutinib earns orphan drug designation in Japan for IgG4-related disease | |
| Exhibit 99.2 | Press Release dated March 4, 2026: Filing of an amendment to the French “Document d’Enregistrement Universel” containing the Annual Financial Report | |
| Exhibit 99.3 | Press Release dated March 5, 2026: Sanofi’s Board of Directors proposes the appointment of Christel Heydemann as an independent director | |
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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: March 10, 2026 | SANOFI | |||||
| By | /s/ Alexandra Roger | |||||
| Name: Alexandra Roger | ||||||
| Title: Head of Legal Corporate & Finance | ||||||
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Exhibit 99.1
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Press Release |
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Sanofi’s rilzabrutinib earns orphan drug designation in Japan for IgG4-related disease
| • | Designation based on positive data from a phase 2 study of rilzabrutinib in IgG4-RD |
| • | Third global orphan drug designation for rilzabrutinib in IgG4-RD, underpinning Sanofi’s commitment to rare immune-mediated diseases |
Paris, March 2, 2026 – The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted orphan drug designation to rilzabrutinib, a novel, oral, reversible covalent Bruton’s tyrosine kinase (BTK) inhibitor, for IgG4-related disease (IgG4-RD). There is still unmet medical need and limited treatment options in Japan for IgG4-RD, a rare, progressive, immune-mediated chronic condition in which the immune system attacks various tissues and organs leading to serious damage. The MHLW grants orphan designation to medicines that address rare diseases or conditions with unmet medical needs.
Rilzabrutinib for the treatment of IgG4-RD was evaluated in a phase 2 study (clinical study identifier: NCT04520451) and results were presented at the European Alliance of Associations for Rheumatology 2025 congress. In IgG4-RD patients, treatment with rilzabrutinib for 52 weeks led to reduction in disease flares and other disease markers and minimized the need for treatment with glucocorticoids. The safety profile of rilzabrutinib in the study was consistent with previous studies in other indications, with no new safety signals observed. Treatment-emergent adverse events reported by >10% of patients include diarrhea, COVID-19, dizziness, dry mouth and nausea. Currently, rilzabrutinib in IgG4-RD is being evaluated in the RILIEF phase 3 study (clinical study identifier: NCT07190196).
Rilzabrutinib is being studied across multiple rare immune-mediated diseases. In 2025, it received approval for immune thrombocytopenia (ITP) in the US, the EU, and the UAE. Additionally, rilzabrutinib is currently under regulatory review for ITP in Japan. Rilzabrutinib has received several expedited designations from global regulatory authorities for ITP, IgG4-RD, warm autoimmune hemolytic anemia (wAIHA), and sickle cell disease (SCD). Other than the approved ITP indications in the US, EU, and UAE, these uses of rilzabrutinib are investigational and have not been evaluated by any regulatory authority.
About rilzabrutinib
Rilzabrutinib, Wayrilz where approved, 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. 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, rilzabrutinib can selectively inhibit the BTK target. Rilzabrutinib is now approved for the treatment of immune thrombocytopenia (ITP) in the US, the EU, and the UAE. Regulatory review for use in ITP is currently ongoing in Japan.
About IgG4-RD
IgG4-RD is a progressive, relapsing, chronic immune-mediated rare disease, which can manifest in almost every organ and can lead to organ damage and irreversible dysfunction with a sometimes fatal outcome. People with IgG4-RD experience flare-ups of the condition characterized by periods of exacerbated symptoms. Due to its rarity and challenges with diagnosis, the global prevalence of IgG4-RD is unknown.
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.
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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 | yun.li3@sanofi.com
Sanofi forward-looking statements
This press release contains forward-looking statements as defined in 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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, and similar expressions. 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, 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, 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 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 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. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
All trademarks mentioned in this press release are the property of the Sanofi group.
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Exhibit 99.2
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Press Release |
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Filing of an amendment to the French “Document d’Enregistrement Universel” containing the Annual Financial Report
Paris, March 4, 2026. Sanofi announces today the filing of an amendment to its “Document d’Enregistrement Universel” containing its Annual Financial Report with the French market regulator Autorité des marchés financiers (AMF).
This amendment notably includes additions to the report on corporate governance established in accordance with French law.
This document is available on the company’s website:
https://www.sanofi.com/en/investors/reports-and-publications/financial-reports-and-regulated-information and on the website of the AMF (www.amf-france.org).
About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating 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
Léo Le Bourhis | + 33 6 75 06 43 81 | leo.lebourhis@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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Exhibit 99.3
|
Press Release |
|
Sanofi’s Board of Directors proposes the appointment of Christel Heydemann as an independent director
Paris, March 5, 2026. The Board of Directors of Sanofi has decided to propose, at the next Annual General Meeting of shareholders scheduled for April 29, 2026, the appointment of Christel Heydemann as an independent director, as well as the renewal of the mandates of Christophe Babule and Jean-Paul Kress.
Patrick Kron, independent director and Chairman of the Nomination, Governance and CSR Committee, will step down from the Board at the end of his term, which will expire at the upcoming Annual General Meeting on April 29. The Board warmly thanks Patrick Kron for his decisive contribution to its work over the past 12 years, particularly with respect to key governance decisions.
Christel Heydemann has been Chief Executive Officer of the Orange Group since April 2022, after serving as a member of the Board of Directors from July 2017. She began her career at Alcatel in 1999, where she held various management positions, including during the merger between Alcatel and Lucent. In 2008, she was appointed Chief Commercial Officer for France and joined the Executive Committee of Alcatel-Lucent France. In 2011, she headed up Human Resources and Transformation for the group. In 2014, Christel Heydemann joined Schneider Electric. In 2017, she was appointed Chairman and Chief Executive Officer of Schneider Electric France. In 2021, she took on the role of Executive Vice President, Europe Operations. A graduate of École Polytechnique and École Nationale des Ponts et Chaussées, Christel Heydemann is actively committed to promoting diversity and innovation, particularly in encouraging women to pursue careers in science and technology. Christel Heydemann is an Officer of the French National Order of Merit and a Knight of the French Legion of Honor.
“We sincerely thank Patrick Kron for the commitment and rigor he has brought to the Board’s work over the past twelve years, both as a director and in the various committee chair roles he has held. The proposed appointment of Christel Heydemann reflects the Board’s determination to further strengthen the diversity of expertise and backgrounds within our governance,” said Frédéric Oudéa, Chairman of the Board of Directors of Sanofi. “Her recognized experience leading major international groups, her expertise in industrial and digital transformation, and her strategic vision will be valuable assets in supporting Sanofi through the next phase of its development.”
With these appointments and the arrival of Belén Garijo as Chief Executive Officer and director, the Board would remain composed of 16 members, including two employee representatives, gender parity (57% of women excluding employee representatives).
The composition of the Board’s specialized committees will be reviewed following the Annual General Meeting scheduled for April 29, 2026.
About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating 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
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
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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Filing Exhibits & Attachments
3 documentsPress Releases
