SNYNF 6-K
Sanofi (SNY)
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 February 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 February 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
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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: February 23, 2026 | SANOFI | |||||
| By | /s/ Alexandra Roger | |||||
| Name: Alexandra Roger | ||||||
| Title: Head of Legal Corporate & Finance | ||||||
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Exhibit 99.1
| Press Release |
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Beyfortus study published in The Lancet Infectious Diseases shows benefit for infants beyond first RSV season
| ● | First study showing that infants immunized against RSV in their first season had fewer RSV hospitalizations in their second season |
| ● | The study also showed a reduction of 85.9% in RSV-related lower respiratory tract infection hospitalizations in the first season |
Data published in The Lancet Infectious Diseases and to be presented at RSVVW ’26 conference in Rome
Paris, February 16, 2026. A universal respiratory syncytial virus (RSV) immunization program using Beyfortus (nirsevimab) was associated with a statistically significant reduction in RSV-related hospitalizations in the second RSV season among infants immunized during their first season, according to a new study published in The Lancet Infectious Diseases. The NIRSE-GAL study, conducted in Galicia, Spain, is the first prospective real-world population study to evaluate the impact of a universal Beyfortus immunization program during two consecutive RSV seasons. The study findings, comparing the number of hospitalizations in immunized infants during their second RSV season versus the number of expected hospitalization cases based on data from recent seasons, are being presented at RSVVW ’26 (Respiratory Syncytial Virus Vaccines for the World) conference in Rome, Italy.
The coverage rate was 94.4% among the cohort (11,796 infants out of 12,492 eligible) and the study showed a substantial reduction of 85.9% (95% confidence interval [CI] 80.2–90.0) in RSV-related lower respiratory tract infection (LRTI) hospitalizations during the first season. The study also showed 55.3% (95% CI 22.5-74.3) fewer hospitalizations in the second RSV season among infants who received a dose of Beyfortus during infancy. By preventing severe RSV infections during the first months of life, a critical period of lung development, it is thought the infants may be less prone to subsequent admissions from either RSV or other infections.
“This universal RSV immunization program with Beyfortus showed decreased RSV-related hospitalizations and outpatient illness burden during the first season, with persistent impact seen on RSV hospitalizations through the second season,” said Federico Martinón-Torres, Head of Pediatrics at Santiago University Hospital in Spain, and principal investigator of the NIRSE-GAL study. “These results offer compelling population-based data to inform infant immunization strategies and economic evaluation models.”
“This study builds upon our wealth of evidence supporting the public health value of a Beyfortus immunization program,” said Thomas Triomphe, Executive Vice President, Vaccines, Sanofi. “It’s exciting to see the significant impact of this infant immunization program during the first RSV season and truly remarkable to consider a benefit across two seasons.”
Further findings
The study also showed reductions in primary care consultations during the first RSV season, including:
| ● | 30.8% (17.5-41.9) reduction in first consultations for acute bronchitis or bronchiolitis; |
| ● | 33.4% (21.6-43.4) reduction in consultations for lower respiratory tract infections and; |
| ● | 27.7% (14.9-38.5) reduction in consultations for wheezing or asthma. |
Furthermore, rehospitalizations in infants previously hospitalized due to RSV decreased considerably during the second RSV season, with a 78.2% (25.6–93.6) reduction in RSV-related
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rehospitalizations and a 62.4% (30.9–79.6) reduction in LRTI rehospitalizations. These data support the hypothesis that early protection against RSV-related damage to the lungs may have lasting beneficial effects on respiratory health.
About RSV
RSV is a highly contagious virus that can lead to serious respiratory illness for infants. It is a leading cause of hospitalization in all infants, with most hospitalizations for RSV occurring in otherwise healthy infants born at term. Older infants born before the RSV season are also at risk of RSV disease and make up around half of infant RSV hospitalizations. Two out of three infants are infected with RSV during their first year of life and almost all children are infected by their second birthday. Globally, in 2019, there were approximately 33 million cases of RSV-associated acute lower respiratory infections leading to more than three million hospitalizations and an estimated 26,300 in-hospital RSV-attributable deaths of children younger than five years. RSV-related direct medical costs, globally — including hospital, outpatient, and follow-up care — were estimated at c.€5 billion in 2017.
About Beyfortus
Beyfortus (nirsevimab) is the first RSV immunization designed to help protect all infants through their first RSV season, including for those born healthy at term or preterm, and those with health conditions that make them vulnerable to RSV disease. Beyfortus is also approved for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
With an extended half-life of 71 days, Beyfortus is a long-acting monoclonal antibody for the prevention of RSV lower respiratory tract disease in infants. Administration is timed to coincide with the RSV season and is provided directly to newborns and infants as a single dose. Beyfortus offers rapid protection without requiring activation of the immune system.
Along with efficacy and safety demonstrated in clinical studies, the effectiveness of Beyfortus has been evaluated in more than 50 real-world studies, including more than 400,000 infants who were immunized. Since the launch, over 11 million infants have been immunized with Beyfortus across more than 45 countries.
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 | [email protected]
Evan Berland | + 1 215 432 0234 | [email protected]
Léo Le Bourhis | + 33 6 75 06 43 81 | [email protected]
Victor Rouault | + 33 6 70 93 71 40 | [email protected]
Léa Ubaldi | +33 6 30 19 66 46 | [email protected]
Timothy Gilbert | + 1 516 521 2929 | [email protected]
Ekaterina Pesheva | +1 410 926 6780 | [email protected]
Investor Relations
Thomas Kudsk Larsen |+ 44 7545 513 693 | [email protected]
Alizé Kaisserian | + 33 6 47 04 12 11 | [email protected]
Keita Browne | + 1 781 249 1766 | [email protected]
Nathalie Pham | + 33 7 85 93 30 17 | [email protected]
Nina Goworek | +1 908 569 7086 | [email protected]
Thibaud Châtelet | + 33 6 80 80 89 90 | [email protected]
Yun Li | +33 6 84 00 90 72 | [email protected]
Sanofi forward-looking statement
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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, 2024. 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
| Press Release |
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Sanofi and Teva’s duvakitug phase 2b maintenance data demonstrated clinically meaningful durable efficacy in ulcerative colitis and Crohn’s disease
| ● | In the RELIEVE UCCD LTE phase 2b study, duvakitug showed robust, durable efficacy for an additional 44 weeks in UC and CD patients who had responded after 14 weeks of induction |
| ● | Duvakitug was well tolerated and safety was consistent with the induction study |
| ● | Findings reinforce the potential of duvakitug which is in ongoing phase 3 programs in UC and CD |
Paris and Parsippany, NJ, February 17, 2026. Positive results from the RELIEVE UCCD long-term extension (LTE) study (clinical study identifier: NCT05668013) of duvakitug, an investigational human monoclonal antibody targeting TL1A, showed durable clinical and endoscopic efficacy maintained over 44 weeks in patients with ulcerative colitis (UC) and Crohn’s disease (CD) that initially responded to the induction phase. RELIEVE UCCD LTE is a double-blind randomized study evaluating the long-term efficacy, safety, and tolerability of duvakitug in UC and CD, the two most common forms of inflammatory bowel disease (IBD).
These longer duration data reinforce the efficacy from the RELIEVE UCCD phase 2b induction study (clinical study identifier: NCT05499130), which demonstrated that patients achieved clinically meaningful response with duvakitug compared to placebo at week 14.
“These results reinforce duvakitug’s potential as a leading TL1A therapy and an important advancement in inflammatory bowel disease treatment with durable efficacy maintained for nearly one year in patients living with ulcerative colitis or Crohn’s disease,” said Houman Ashrafian, Executive Vice President, Head of Research and Development, Sanofi. “With phase 3 studies underway, we’re committed to advancing duvakitug for patients who need new options, and it remains a key opportunity in our pipeline.”
The study enrolled 130 patients who responded to duvakitug in the RELIEVE UCCD induction study and entered a 44-week maintenance period. Patients were re-randomized to receive either a 450 mg or 900 mg subcutaneous dose of duvakitug every four weeks for up to a total of 58 weeks of exposure. At week 44 of the maintenance period:
| ● | UC: 58% (900 mg) and 47% (450 mg) of patients treated with duvakitug achieved the primary endpoint of clinical remission per the modified Mayo score (mMS). |
| ● | CD: 55% (900 mg) and 41% (450 mg) of patients treated with duvakitug achieved the primary endpoint of endoscopic response as defined by the Simple Endoscopic Score for CD (SES-CD). |
| ● | In both UC and CD, consistent benefits were observed across additional efficacy endpoints. |
Both doses of duvakitug were well tolerated. The most frequent observed adverse events (≥5% of all patients) with pooled duvakitug doses were upper respiratory tract infection, nasopharyngitis, Crohn’s disease, and hypertension and were consistent with the RELIEVE UCCD phase 2b induction study. Detailed results from the study will be presented at a forthcoming medical meeting.
“One of the persistent challenges in treating ulcerative colitis and Crohn’s disease isn’t just achieving an initial response, but sustaining it,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, Teva. “These phase 2b results further reinforce TL1A as a compelling target and clearly strengthen the case that duvakitug has the potential to be a best-in-class therapy. They also provide further evidence to support additional indications we anticipate announcing this year, with the goal of bringing meaningful innovation to patients.”
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About IBD
IBD is an autoimmune disorder characterized by chronic inflammation of the gastrointestinal (GI) tract. Globally, approximately 4.9 million cases of IBD have been identified, with incidence rising in several regions. The two main types of IBD are UC and CD, which are characterized by repetitive cycles of relapses and remission. Common symptoms of both conditions include persistent diarrhea, rectal bleeding, abdominal pain, loss of appetite, and weight loss.
Prolonged inflammation can lead to damage within the GI tract, including fibrosis, a common complication of IBD characterized by an excessive accumulation of scar tissue in the intestinal wall, which may cause narrowing and obstruction.
Currently, there is no cure for IBD. The goal of current treatment is to induce and maintain remission and prevent flares.
About the RELIEVE UCCD phase 2b program
The RELIEVE UCCD program is comprised of an induction study and a long-term extension.
RELIEVE UCCD: A 14-week phase 2b, randomized, double-blinded, dose-ranging induction study to evaluate the efficacy, safety, pharmacokinetics, and tolerability of duvakitug in adults with moderate-to-severe UC or CD. The study was an innovative and efficient basket study design allowing the inclusion of patients with either UC or CD. It is the first and only randomized, blinded and placebo-controlled phase 2 study to investigate the impact of TL1A in CD.
RELIEVE UCCD LTE: An ongoing study to evaluate the long-term efficacy and safety of duvakitug. Patients who received duvakitug, completed the 14-week induction study, and were responders, entered a 44-week double-blind maintenance period and were re-randomized to receive either 450 mg or 900 mg of subcutaneous duvakitug every four weeks. Patients who completed the 44-week maintenance period may continue to receive duvakitug in an open-label extension.
Primary efficacy endpoints for both the 14-week induction study and the 44-week maintenance period are clinical remission (as defined by mMS) in the UC cohort or endoscopic response (as defined by SES-CD) in the CD cohort. The study includes sites in the US, Europe, Israel, and Asia.
About duvakitug
Duvakitug, a human monoclonal antibody targeting TL1A, is currently in phase 3 clinical studies for the treatment of UC and CD. TL1A signaling is believed to amplify inflammation and drive fibrosis associated with IBD through binding to its receptor, DR3. Duvakitug preferentially inhibits TL1A-DR3 signaling over DcR3 (decoy receptor 3) binding, with the potential to reduce inflammation and fibrosis.
The safety and efficacy of duvakitug have not been reviewed by any regulatory authority.
About the Teva and Sanofi collaboration
Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug for the treatment of UC and CD. Each company will equally share the development costs globally, and the net profits and losses in major markets, with other markets subject to a royalty arrangement. Sanofi is leading the phase 3 clinical development program. Teva will lead commercialization of the product in Europe, Israel, and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia, and the rest of the world.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the
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future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
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
Sanofi Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | [email protected]
Evan Berland | +1 215 432 0234 | [email protected]
Léo Le Bourhis | +33 6 75 06 43 81 | [email protected]
Victor Rouault | +33 6 70 93 71 40 | [email protected]
Timothy Gilbert | +1 516 521 2929 | [email protected]
Léa Ubaldi | +33 6 30 19 66 46 | [email protected]
Ekaterina Pesheva | +1 410 926 6780 | [email protected]
Sanofi Investor Relations
Thomas Kudsk Larsen |+44 7545 513 693 | [email protected]
Alizé Kaisserian | +33 6 47 04 12 11 | [email protected]
Keita Browne | +1 781 249 1766 | [email protected]
Nathalie Pham | +33 7 85 93 30 17 | [email protected]
Nina Goworek | +1 908 569 7086 | [email protected]
Thibaud Châtelet | +33 6 80 80 89 90 | [email protected]
Yun Li | +33 6 84 00 90 72 | [email protected]
Teva Media Inquiries
Teva Investor Relations Inquires
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 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 performance. 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, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, 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, 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, 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 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, 2024. 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, with the exception of Teva, a trademark of Teva Pharmaceutical Industries Ltd.
Teva Cautionary Note Regarding Forward Looking Statements
This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize duvakitug (anti-TL1A) under the our collaboration with Sanofi; our ability to successfully compete in the marketplace, including our ability to develop
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and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
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Exhibit 99.3
| Press Release |
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Filing of the 2025 U.S. Form 20-F and French “Document d’Enregistrement Universel” containing the Annual Financial Report
Paris, February 17, 2026. Sanofi announces today the filing of its Form 20-F with the U.S. Securities and Exchange Commission (SEC) and its “Document d’Enregistrement Universel” containing its Annual Financial Report with the French market regulator Autorité des marchés financiers (AMF).
These documents are available on the company’s website:
https://www.sanofi.com/en/investors/reports-and-publications/financial-reports-and-regulated-information
In addition, the Form 20-F is available on the website of the SEC (www.sec.gov) and the “Document d’Enregistrement Universel” is available on the website of the AMF (www.amf-france.org). A hard copy of these documents, each of which contains our complete audited financial statements, may be received free of charge, upon request.
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 | [email protected]
Léo Le Bourhis | + 33 6 75 06 43 81 | [email protected]
Investor Relations
Thomas Kudsk Larsen |+ 44 7545 513 693 | [email protected]
Alizé Kaisserian | + 33 6 47 04 12 11 | [email protected]
Keita Browne | + 1 781 249 1766 | [email protected]
Nathalie Pham | + 33 7 85 93 30 17 | [email protected]
Nina Goworek | +1 908 569 7086 | [email protected]
Thibaud Châtelet | + 33 6 80 80 89 90 | [email protected]
Yun Li | +33 6 84 00 90 72 | [email protected]
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