Sanofi (NASDAQ: SNY) plans €1B buyback and reports late-stage drug wins
Rhea-AI Filing Summary
Sanofi filed a 6-K summarizing three developments: regulatory progress for Rezurock, pivotal data for venglustat, and a new share buyback mandate.
The European regulator’s advisory committee issued a positive opinion recommending conditional EU marketing authorization for Rezurock to treat chronic graft-versus-host disease in adults and certain adolescents after other options are exhausted. This follows a re-examination of an earlier negative view and is based on clinical and real-world data, including a phase 2 study showing a 74% overall response rate.
Sanofi also reported that venglustat met the primary and most key secondary endpoints in a phase 3 trial for type 3 Gaucher disease and plans global regulatory filings. Separately, the company signed a mandate to repurchase up to €1 billion of its own shares between February 3 and December 31, 2026.
Positive
- Rezurock receives a positive EU advisory opinion for conditional marketing authorization in chronic graft-versus-host disease after multiple prior therapies, potentially expanding Sanofi’s rare disease revenue base.
- Venglustat succeeds in a phase 3 GD3 trial, meeting the primary and most key secondary endpoints, and Sanofi plans global regulatory filings, reinforcing its position in lysosomal storage disorders.
- Sanofi launches a share buyback mandate of up to €1 billion running through December 31, 2026, enhancing capital returns to shareholders.
Negative
- None.
Insights
Regulatory wins, late-stage data, and a €1 billion buyback support Sanofi’s growth and capital return story.
The positive advisory opinion for Rezurock in chronic graft-versus-host disease in Europe strengthens Sanofi’s rare disease and transplant-related portfolio. The recommendation follows additional review and relies on phase 2 data showing a best overall response rate of
For venglustat, the phase 3 LEAP2MONO study in type 3 Gaucher disease met its primary endpoint and three of four key secondary endpoints in adults and adolescents. Sanofi intends to pursue global regulatory filings, which, if successful, could expand its Gaucher franchise into neurologic manifestations where no approved therapies exist today.
On capital allocation, Sanofi authorized a mandate to repurchase shares for up to
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 ☐
1
In January and 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
| Exhibit No. |
Description | |
| Exhibit 99.1 | Press Release dated January 30, 2026: Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease | |
| Exhibit 99.2 | Press Release dated February 2, 2026: Sanofi’s venglustat met all primary endpoints in a phase 3 study of type 3 Gaucher disease | |
| Exhibit 99.3 | Press Release dated February 3, 2026: Sanofi announces the signing of a share buyback mandate for up to €1 billion | |
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: February 6, 2026 | SANOFI |
| By |
/s/ Alexandra Roger | |
| Name: Alexandra Roger | ||
| Title: Head of Legal Corporate & Finance |
3
Exhibit 99.1
| Press Release |
|
Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease
| • | Recommendation supported by safety and efficacy results from several clinical studies and real-world evidence |
| • | If approved, Rezurock would offer a new treatment option in the EU for adult patients and in children aged 12 years and older in late line chronic GVHD |
Paris, January 30, 2026. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the conditional marketing authorisation of Rezurock (belumosudil) in the EU for the treatment of adults and in children aged 12 years and older with a body weight of at least 40 kg, with chronic graft-versus-host disease (GvHD). The medicine is to be used when other treatment options provide limited clinical benefit, are not suitable, or have been exhausted. This positive recommendation comes after Sanofi requested a re-examination of the prior negative opinion adopted by the CHMP in October 2025. The final European Commission decision is expected in the coming weeks.
“Chronic GVHD can involve multiple organs and profoundly affect patients’ daily lives, limiting everyday activities and taking a substantial emotional toll,” said Prof Mohamad Mohty, Professor of Haematology, Head of the Haematology and Cellular Therapy Department at Hôpital Saint-Antoine and Sorbonne University, Paris, France. “For patients who have exhausted available treatment options, this positive opinion marks an important step forward in our ability to better manage this challenging disease.”
“We sought a re-examination of the CHMP opinion, and made the commitment to conduct a new post-approval confirmatory study, given the limited late-line treatment options available for EU patients living with chronic GVHD and the body of Rezurock clinical evidence generated including data from patients in Europe,” said Olivier Charmeil, Executive Vice President, General Medicines, Sanofi. “We remain committed to supporting the GVHD community and welcome this positive CHMP opinion, which brings us closer to delivering a new approved treatment in the EU for adult and adolescent GVHD patients who are waiting.”
This CHMP recommendation is based on safety and efficacy results from several clinical studies and real-world evidence. This includes the randomised, multicentre ROCKstar phase 2 study, which demonstrated clinically meaningful and durable responses with Rezurock for patients living with chronic GVHD after stem cell transplant and at least two prior lines of systemic therapy. Treatment was generally well tolerated. Under the CHMP positive opinion for conditional marketing authorisation, Sanofi will also conduct a confirmatory randomised controlled study.
Rezurock is approved in 20 countries, including the US, UK, and Canada for the treatment of patients 12 years and older with chronic GVHD after failure of at least two prior lines of systemic therapy and in China after failure of one prior line of systemic therapy.
More than 17,000 patients living with chronic GVHD have been treated with Rezurock in approved countries since its first approval in the US in July 2021.
About Rezurock
Rezurock (belumosudil) is Sanofi’s first-in-class selective ROCK2 (Rho-associated coiled- coil kinase 2) inhibitor (ROCK2i). It has been shown to help many different types of people with chronic GVHD after failure of any two other types of treatment.
Sanofi is committed to investigating the safety and efficacy of Rezurock in other age groups and indications, including through ongoing studies for paediatric patients with chronic GVHD from one year old who have been treated with at least two prior lines of systemic therapy and for patients with chronic lung allograft dysfunction. These additional indications are currently under investigation and have not been approved by regulatory authorities.
About the ROCKstar study
ROCKstar was a pivotal phase 2, open label, non-controlled, randomised, multicentre study that evaluated the efficacy and safety of Rezurock in patients with chronic GVHD after receiving 2 to 5 prior lines of systemic therapy. A 3-year, open-label, follow-up analysis of the ROCKstar study evaluated the long-term efficacy of Rezurock.
Treatment consisted of Rezurock 200 mg and was administered continuously until clinically significant progression of chronic GvHD or unacceptable toxicity. The primary endpoint was best overall response rate (ORR) at any time.
Study results demonstrated clinically meaningful and statistically significant best ORR of 74% on treatment with Rezurock (n=77, 95% CI, 63-83). The most common adverse reactions were fatigue (46%), diarrhoea (35%), nausea (35%), dyspnoea (32%), cough (30%) and upper respiratory tract infections (26%).
About chronic graft-versus-host disease
GVHD is a life-threatening complication that can occur following stem cell transplant (or allogeneic hematopoietic stem cell transplant) where the donor’s (graft) cells attack the host’s cells, leading to inflammation and fibrosis (scarring or thickening) that can damage multiple tissues and organs. Chronic GVHD devastates the lives of up to 50% of patients who undergo an allogeneic hematopoietic stem cell transplant. GVHD is considered one of the main causes of morbidity (poor health) and late non-relapse mortality after stem cell transplant. The consequences are far-reaching, both in terms of the burden it can place on the individual’s physical and emotional well-being, as well as the broader socio-economic impact.
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
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
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
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, 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 media update are the property of the Sanofi group.
Exhibit 99.2
| Press Release |
|
Sanofi’s venglustat met all primary endpoints in a phase 3 study of type 3 Gaucher disease
| • | In the LEAP2MONO phase 3 study, venglustat, dosed orally once daily, demonstrated clinically meaningful efficacy in patients with type 3 Gaucher disease (GD3), a rare lysosomal storage disorder |
| • | Venglustat demonstrated superiority versus enzyme replacement therapy in addressing neurological symptoms in GD3, for which there are no approved treatments |
| • | Sanofi will pursue global regulatory submissions for GD3 |
| • | In the PERIDOT phase 3 study in Fabry disease, venglustat did not show superiority on the patient-reported primary endpoint and an additional phase 3 CARAT study is ongoing |
Paris, February 2, 2026. Positive results from the LEAP2MONO phase 3 study (clinical study identifier: NCT05222906) demonstrated that venglustat met the primary and three out of four key secondary endpoints in adults and pediatric patients (12 years and older) with neurological manifestations of type 3 Gaucher disease (GD3), a rare lysosomal storage disorder.
Venglustat, which works by reducing the abnormal accumulation of sugar-and-fat molecules in cells and organs, is an investigational glucosylceramide synthase inhibitor (GCSi) that crosses the blood-brain barrier with the goal of targeting some of the neurological aspects of GD3 that currently have no approved therapies. Sanofi has supported the Gaucher disease community for decades as part of an over 40-year commitment to improving care for rare diseases.
The results will be shared this week at the 22nd annual WORLDSymposium™ as late-breaking research.
“These findings underscore Sanofi’s commitment to rare disease research and the promise we aim to deliver for people living with these conditions,” said Houman Ashrafian, Executive Vice President and Head of Research and Development at Sanofi. “What excites us most is the potential to address critical unmet medical needs. A daily pill could make a serious difference for Gaucher patients facing neurological challenges. Most importantly, none of this would be possible without the courage of the patients and families who participate in our studies, and for that we owe them a debt of gratitude.”
In the LEAP2MONO study, GD3 patients receiving venglustat demonstrated statistically significant improvements in neurological symptoms measured by a global test score for two assessments, the Scale for Assessment and Rating of Ataxia (SARA) modified total score and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), at week 52 compared with those receiving enzyme replacement therapy (ERT) (p=0.007). Venglustat performed as well as ERT on non-neurological outcomes, including changes in spleen volume, liver volume, and hemoglobin levels, three key secondary endpoints of the study.
Venglustat is also being studied for the treatment of Fabry disease, another rare lysosomal storage disorder. Data from the phase 3 PERIDOT study (clinical study identifier: NCT05206773) show that reduction in neuropathic and abdominal pain was observed in both study arms and the primary endpoint was not met. Additional analyses of the data are ongoing with more information to be shared at a future medical meeting. A second phase 3 study, CARAT (clinical study identifier: NCT05280548), evaluating the effect of venglustat on left cardiac ventricular mass index in men and women with Fabry disease, is ongoing.
Venglustat was well tolerated overall with no new safety signals compared with previous studies. In LEAP2MONO, the most commonly reported adverse events during treatment among patients receiving venglustat (21 individuals) compared with those receiving ERT (22 individuals) were headache (14.3% in the venglustat arm versus 18.2% in the ERT arm), nausea (14.3% versus 4.5%), spleen enlargement (14.3% versus 0), and diarrhea (14.3% versus 0).
Sanofi will pursue global regulatory filings for venglustat in GD3. Venglustat is investigational, and its safety and efficacy have not been evaluated by any regulatory authority.
Sanofi currently markets Fabrazyme, an ERT for Fabry disease, and Cerezyme and Cerdelga for Gaucher disease, an ERT and oral therapy, respectively, in markets around the world. In January 2026, the US approved an expanded label for Cerezyme to include non-central nervous system (CNS) manifestations of GD3, building on its long-standing approval in the US for GD1. This US supplemental label expansion was based exclusively on real-world evidence and leveraged data from the International Collaborative Gaucher Group Gaucher Registry. With the US label expansion, Cerezyme can now be prescribed globally to patients with either GD1 or GD3.
About Gaucher disease
Gaucher disease (GD) is a rare inherited lysosomal storage disease that results from a deficiency of an enzyme called glucocerebrosidase (also known as acid ß-glucosidase), leading to the accumulation of molecules called glycosphingolipids (GSLs), particularly in macrophages of the spleen, liver, bone marrow, and lungs. There are three major forms within the clinical spectrum of Gaucher disease: GD1, which is characterized by the lack of (or late) central nervous system (CNS) involvement; GD2, which is the acute neuronopathic form; and GD3, which is the chronic neuronopathic form. In people with GD3, accumulation of GSLs in the CNS can result in neurological manifestations, including ataxia and cognitive deficits, in addition to the systemic manifestations seen in GD1, such as liver and spleen enlargement, anemia, thrombocytopenia, or bone disease. Systemic manifestations of GD3 are treated with ERT, but there are no approved treatments for neurologic manifestations of GD3.
About Fabry disease
Fabry disease is an inherited rare lysosomal storage disease that results from a deficiency of functional alpha-galactosidase A (α-Gal A), leading to a build-up of GSLs, causing progressive cellular accumulation and organ damage in the kidney, cardiovascular and cerebrovascular systems. Neuropathic pain, abdominal pain and other gastrointestinal symptoms are among the first clinical manifestations of Fabry disease and can substantially impact activities of daily living. Clinically, there are two major subtypes: the more severe classic phenotype that presents in childhood with little or no functional α-Gal A enzymatic activity and the non-classic phenotype that presents later in life, typically in adulthood. Non-classic patients have residual α-Gal A activity but progressively accumulate GSLs.
About venglustat
Venglustat is a novel, investigational oral glucosylceramide synthase inhibitor (GCSi), designed to cross the blood brain barrier (i.e., brain-penetrant), that has the potential to slow the progression of certain diseases by inhibiting abnormal GSL accumulation and its physio-pathologic consequences. GSLs are cellular building blocks whose abnormal accumulation is implicated in several rare diseases leading to both cell dysfunction and disease progression. Venglustat was previously granted orphan designation in the EU, the USA and Japan for its potential treatment of both GD3 and Fabry disease. It also received fast-track designation in the US Food & Drug Administration (FDA) for its potential use in GD3 and Fabry disease.
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About the LEAP2MONO study
The LEAP2MONO phase 3 study was a double-blind, double-dummy, active-comparator, two-arm study that evaluated the efficacy and safety of once daily oral venglustat versus intravenous ERT every two weeks in adults and pediatric patients aged 12 and older with GD3. Forty-three patients were randomized [1:1] to receive venglustat and placebo infusion or ERT and placebo tablet. Patients must have been treated with ERT for at least three years and achieved therapeutic goals for systemic disease manifestations. The primary endpoints for the study was change in SARA modified total score and change in RBANS total scale index score for patients receiving venglustat versus those receiving ERT from baseline to week 52. Systemic key secondary endpoints include percent change in spleen volume, liver volume and platelet count and change in hemoglobin levels. Biomarker key secondary endpoints include percent change in cerebrospinal fluid and plasma GL1 and lyso-GL1. The LEAP2MONO study is ongoing and results from its open-label phase will be presented in the future when available.
About the PERIDOT study
The PERIDOT phase 3 study was a double-blind, randomized, placebo-controlled study that evaluated the efficacy and safety of venglustat on neuropathic and abdominal pain in patients aged 16 years and older with Fabry disease. The study randomized 122 patients 1:1 to receive venglustat or placebo. Patients must have been treatment-naïve or untreated for at least six months. The primary endpoint was the percent change from baseline on patient-defined most bothersome symptoms (neuropathic pain in upper extremities, neuropathic pain in lower extremities or abdominal pain), as assessed by the FD-PRO instrument, in those treated with venglustat versus placebo. Secondary endpoints include percent change from baseline in plasma globotriaosylsphingosine (lyso-GL-3), frequency of rescue pain medication use, change from baseline in the percentage of days with diarrhea, percent change from baseline in tiredness component of FD-PRO, and proportion of responders on the patient-defined most bothersome symptoms.
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 | +33 6 70 93 71 40 | 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
Nina Goworek | nina.goworek@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 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.
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Exhibit 99.3
| Press Release |
|
Sanofi announces the signing of a share buyback mandate for up to €1 billion
Paris, February 3, 2026. On January 29, 2026, Sanofi announced its intention to execute a share buyback program in 2026 of €1 billion.
On February 2, 2026, Sanofi entered a mandate with an investment service provider for this program. Under the terms of the mandate, Sanofi will repurchase its own shares for a total consideration of up to €1 billion, between February 3, 2026, and December 31, 2026, at the latest1.
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 | 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 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”, “seeks”, “targets”, “goal”, “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, political pressure to provide beneficial pricing in the United States including to State Medicaid programs of “most favored nation” drug prices and elsewhere, 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.
1 Subject to the renewal by the Annual General Meeting to be held on April 29, 2026, of the authorization granted to the Board of Directors to carry out transactions in the company’s shares.
FAQ
What key developments did Sanofi (SNY) report in its latest 6-K?
What is the significance of the CHMP positive opinion on Sanofi’s Rezurock?
What did Sanofi (SNY) reveal about its phase 3 venglustat trial in type 3 Gaucher disease?
How large is Sanofi’s new share buyback program and over what period?
How many patients have been treated with Rezurock so far, according to Sanofi?
In which rare diseases is Sanofi developing venglustat, based on this filing?
