Sanofi 6-K: Lunsekimig Phase 2, EU Dupixent OK
Sanofi reports two major immunology updates.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Sanofi reports two major immunology updates. Its experimental drug lunsekimig met primary and key secondary endpoints in phase 2 respiratory studies in moderate-to-severe asthma (AIRCULES) and chronic rhinosinusitis with nasal polyps (DUET), showing fewer exacerbations and better lung function or polyp scores versus placebo, with a generally acceptable safety profile. A separate phase 2b atopic dermatitis study (VELVET) missed its primary endpoint but improved key skin-clearance measures. Lunsekimig is progressing into new phase 2 and phase 3 programs in high-risk asthma.
Sanofi also announces that the European Commission approved Dupixent for moderate-to-severe chronic spontaneous urticaria in children aged two to 11 years who do not respond adequately to antihistamines and are naïve to anti-IgE therapy. This expands Dupixent’s prior EU approval in CSU for adults and adolescents, based on the LIBERTY-CUPID phase 3 program, where Dupixent reduced itch and hives and improved disease control with a safety profile consistent with earlier dermatology uses.
Insights
Sanofi advances a new respiratory biologic while broadening Dupixent’s pediatric reach in Europe.
Sanofi highlights two levers of long-term growth: pipeline progress and label expansion. Lunsekimig’s phase 2 success in asthma and CRSwNP, including fewer exacerbations and better lung function or polyp scores versus placebo, supports moving into phase 2 and phase 3 respiratory programs.
The atopic dermatitis miss on the primary endpoint in VELVET tempers the molecule’s dermatology potential but secondary skin-clearance gains preserve optionality. In parallel, the EU approval of Dupixent for chronic spontaneous urticaria in children aged two to 11 years extends an established franchise into a younger population with limited targeted options.
Together, these developments underscore a strategy centered on type 2 inflammation: a new investigational asset in respiratory disease and a broader commercial footprint for Dupixent in CSU. Actual financial impact will depend on future late-stage data, regulatory decisions outside the EU, and pediatric uptake trends disclosed in subsequent filings.
Key Figures
Key Terms
chronic spontaneous urticaria medical
Nanobody VHH medical
type 2 inflammation medical
EASI-75 medical
fractional exhaled nitric oxide (FeNO) medical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Sanofi (SNY) announce about lunsekimig in this 6-K filing?
How did lunsekimig perform in Sanofi’s atopic dermatitis VELVET study?
What new Dupixent indication for Sanofi (SNY) was approved in the EU?
On what clinical data is the new pediatric CSU approval for Dupixent based?
What safety profile did Sanofi report for lunsekimig in phase 2 studies?
How is Dupixent dosed for children with CSU according to Sanofi’s update?
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 April 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 April 2026, Sanofi published the press releases attached hereto as Exhibits 99.1 and 99.2 which are incorporated herein by reference.
Exhibit Index
| Exhibit No. |
Description | |
| Exhibit 99.1 | Press Release dated April 7, 2026: Sanofi’s lunsekimig met primary and key secondary endpoints in phase 2 respiratory studies in asthma and CRSwNP | |
| Exhibit 99.2 | Press Release dated April 13, 2026: Sanofi and Regeneron’s Dupixent approved in the EU as the first targeted medicine to treat young children with chronic spontaneous urticaria | |
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: April 15, 2026 |
By |
SANOFI
/s/ Alexandra Roger |
| |||
| Name: Alexandra Roger Title: Head of Legal Corporate & Finance |
3
Exhibit 99.1
|
Press Release |
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Sanofi’s lunsekimig met primary and key secondary endpoints in phase 2 respiratory studies in asthma and CRSwNP
| • | The AIRCULES phase 2b study achieved its primary and key secondary endpoints in moderate-to-severe asthma regardless of biomarker status |
| • | The DUET phase 2a study met its primary and key secondary endpoints in chronic rhinosinusitis with nasal polyps, reinforcing lunsekimig’s potential as a respiratory treatment |
| • | The exploratory VELVET phase 2b study did not meet its primary endpoint in moderate-to-severe atopic dermatitis |
| • | In all studies, lunsekimig was well tolerated |
Paris, April 7, 2026. Phase 2 studies of lunsekimig in two chronic respiratory diseases met their primary and key secondary endpoints compared to placebo. Lunsekimig, a novel bispecific Nanobody® VHH, is made of five linked antibody fragments designed to simultaneously block TSLP and IL-13, two separate drivers of inflammation that contribute to tissue damage in asthma and related diseases. In both studies, lunsekimig was well tolerated, with an acceptable safety profile.
“These data are promising and support our belief that the dual-targeting mechanism of lunsekimig may offer a novel treatment option for patients living with respiratory diseases, including asthma,” said Houman Ashrafian, Executive Vice President, Head of Research & Development at Sanofi. “Importantly, these findings underscore lunsekimig’s potential to address multiple critical aspects of respiratory disease management through its unique mechanism.”
In the AIRCULES phase 2b study (clinical study identifier: NCT06102005), lunsekimig met its primary and key secondary endpoints demonstrating a statistically significant and clinically meaningful reduction in exacerbations and improvement in lung function, as measured by pre-bronchodilator forced expiratory volume in one second (pre-BD FEV1). The study enrolled adult patients with moderate-to-severe asthma, a form of the disease marked by recurrent symptoms and frequent flareups despite standard-of-care treatment.
The DUET phase 2a proof-of-concept study (clinical study identifier: NCT06454240), of lunsekimig in chronic rhinosinusitis with nasal polyps (CRSwNP), met its primary endpoint of change in nasal polyp score from baseline and met its key secondary endpoints of change in patient reported nasal congestion/obstruction score and change in Lund-Mackay Computed Tomography (LMK-CT) score, all compared to placebo at Week 24.
The separate exploratory VELVET phase 2b study (clinical study identifier: NCT06790121) evaluating lunsekimig in moderate-to-severe atopic dermatitis did not meet its primary endpoint of percent change from baseline in eczema area severity index (EASI) score. However, improvements were seen in the key secondary endpoints measuring skin clearance including EASI-75 (proportion of patients reaching a 75% or greater improvement in the EASI total score), and vIGA-AD 0/1 (proportion of patients reaching validated investigator global assessment scale for atopic dermatitis score of 0 or 1).
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Across these studies, lunsekimig was generally well tolerated. In the AIRCULES study, among those who received at least one dose of lunsekimig, the most common (≥5%) treatment-emergent adverse events (TEAEs) were nasopharyngitis, upper respiratory tract infection, headache, and dose scheduling errors. In the DUET study, among those who received at least one dose of lunsekimig, the most common (≥5%) TEAEs were injection site reaction or erythema, viral upper respiratory tract infection, nasopharyngitis, epistaxis, ear pain, and increased creatine phosphokinase. Overall, rates of serious adverse events and TEAEs leading to treatment discontinuation in both studies were similar in the lunsekimig group and the placebo group. In the VELVET study, lunsekimig was generally well tolerated and had a safety profile consistent with the other studies.
Detailed results from the AIRCULES, DUET, and VELVET studies will be presented at upcoming medical congresses.
Lunsekimig is currently in clinical development in the AIRLYMPUS phase 2 study in high-risk asthma (clinical study identifier: NCT06676319) and in the PERSEPHONE and the THESEUS phase 3 studies (clinical study identifiers PERSEPHONE: NCT07190209, THESEUS: NCT07190222), and its safety and efficacy have not been evaluated by any regulatory authority.
About asthma
Asthma is one of the most common chronic diseases worldwide, with an estimated 262 million patients diagnosed globally as of 2019. However, despite several available therapies, more than 50% of patients have asthma that is not well controlled. A significant unmet need persists for treatments that prevent and reduce asthma exacerbations, which profoundly diminish patients’ quality of life, disrupt daily activities, and contribute substantially to healthcare resource utilization.
About CRSwNP
CRSwNP is a persistent inflammatory disease of the nose and sinuses characterized by the presence of soft, noncancerous growths, called nasal polyps, in the nasal passages. Individuals with CRSwNP often experience symptoms such as nasal congestion, facial pressure, and a reduced sense of smell, which can significantly impact their quality of life. The majority of patients with CRSwNP have comorbid asthma, which increases in frequency with severity of the disease.
About the AIRCULES study
AIRCULES was a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to evaluate the efficacy, safety, and tolerability of subcutaneous lunsekimig added to standard of care in adult patients with moderate-to-severe asthma across the range of FeNO (fractional exhaled nitric oxide) and eosinophil values. Lunsekimig was administered in multiple dosing regimens, and the primary endpoint was the annualized rate of asthma exacerbation events over 48 weeks. The key secondary endpoint evaluated lung function improvement, as measured by pre-BD FEV1 at Week 48. Lung function was assessed indirectly by measuring the volume of air a patient can exhale forcefully in one second. The study included sites across the US, Canada, Argentina, Brazil, Chile, China, India, Israel, Japan, Mexico, South Africa, South Korea, Turkey, and the UK.
About the DUET study
DUET was a randomized, double-blind, placebo-controlled, parallel-group phase 2a study designed to evaluate the efficacy, safety, and tolerability of subcutaneous lunsekimig in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Key objectives include measuring the efficacy and safety of lunsekimig compared to placebo over 24 weeks. The primary endpoint was change in nasal polyps score from baseline at Week 24 through bilateral endoscopy and the key secondary endpoints were change from baseline in patient-reported nasal congestion/obstruction score and change from baseline in LMK-CT score, both at Week 24. The study included sites across the US, Argentina, Belgium, Bulgaria, Poland, and the UK.
About the VELVET study
VELVET was a randomized, double-blind, placebo-controlled, multicenter exploratory study to assess the efficacy and safety of three subcutaneous dose regimens of lunsekimig in adult patients with moderate-to-severe atopic dermatitis. Key objectives include measuring the efficacy and safety of subcutaneous lunsekimig compared to placebo over 24 weeks. Lunsekimig was administered in three dosing regimens, and the primary endpoint was the percent change in EASI score from baseline at week 24. The study included sites across the United States, Czechia, Japan, and Poland.
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About lunsekimig
Lunsekimig is a novel, pentavalent Nanobody® VHH that combines bispecific targeting of TSLP, an upstream initiator of inflammation and IL-13, a downstream cytokine causing tissue organ damage in respiratory diseases. As a pentavalent Nanobody® VHH (variable heavy-chain domains of a heavy-chain antibody), lunsekimig is made of five linked antibody fragments designed to simultaneously block TSLP and IL-13, which drive airway inflammation and can contribute to tissue damage in certain diseases and bind albumin for longer half-life. Pre-clinical research suggests that the combination of these targets simultaneously can potentially lead to additive and synergistic benefits in immune-mediated diseases such as asthma.
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
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.
All trademarks mentioned in this press release are the property of the Sanofi group.
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Exhibit 99.2
| Press Release |
|
Sanofi and Regeneron’s Dupixent approved in the EU as the first targeted medicine to treat young children with chronic spontaneous urticaria
| • | Approval in CSU for children two to 11 years of age is based on data from the LIBERTY-CUPID clinical study program, including an extrapolation of efficacy data showing that Dupixent significantly reduced urticaria activity compared with placebo in adults |
| • | The latest approval expands Dupixent’s indication for CSU in the EU to children as young as two years; Dupixent is now approved for children less than 12 years of age across four chronic diseases driven in part by type 2 inflammation |
Paris and Tarrytown, NY, April 13, 2026. The European Commission has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged two to 11 years with inadequate response to histamine-1 antihistamines (H1AH) and who are naïve to anti-immunoglobulin E (IgE) therapy for CSU. This expands the previous approval in the EU for adults and adolescents aged 12 years and older with CSU, a chronic, inflammatory skin disease that causes sudden and debilitating hives and recurring itch.
“Previous treatment options for young children with chronic spontaneous urticaria left many patients with uncontrolled disease where the unpredictable appearance of itch and hives continued to disrupt their daily lives,” said Alyssa Johnsen, MD, PhD, Global Therapeutic Area Head, Immunology Development at Sanofi. “Dupixent, which inhibits signaling of IL4 and IL13, two of the key and central drivers of type 2 inflammation, provides a first-of-its kind approach to addressing chronic spontaneous urticaria in young children. This approval demonstrates our commitment to extending the value of Dupixent to all who may benefit, including young children.”
The approval in the EU is based on data from the LIBERTY-CUPID clinical study program. This includes an extrapolation of efficacy data in adults from two phase 3 studies (Study A and Study C; clinical study identifier: NCT04180488) complemented by pharmacokinetic, safety, and efficacy data from the single-arm CUPIDKids phase 3 study in children aged two to 11 years with CSU (clinical study identifier: NCT05526521). Study A and Study C demonstrated Dupixent significantly reduced urticaria activity (a composite of itch and hives) and individual measures of itch and hive severity compared with placebo at Week 24. Dupixent also increased the percentage of patients with well-controlled disease and complete response at Week 24 compared with placebo.
Safety results from Study A, Study C, and CUPIDKids were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. The most common adverse reactions for Dupixent overall are injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia. Additional adverse reactions of injection site induration, injection site dermatitis, and injection site bruising or hematoma were reported in the CSU adult and adolescent studies.* The adverse event more commonly observed with Dupixent (≥5%) than placebo in Study A and Study in adults and adolescents with CSU was COVID-19. Safety data for children aged two to 11 years with CSU were generally consistent with the safety profile for adult and adolescent patients with CSU treated with Dupixent.
“Young children suffering from chronic spontaneous urticaria often experience an unpredictable barrage of unrelenting itch and visible hives during the critical years of their growth and development. As the first and only targeted medicine for young children in the EU with CSU, Dupixent has the potential to become the new standard of care for those who remain symptomatic despite other available treatments,” said George D. Yancopoulos, MD, PhD, Board co-Chair, President and Chief Scientific Officer at Regeneron. “Dupixent is the most widely used innovative branded antibody medicine in the world, and this fourth approval for young children with chronic diseases driven in part by type 2 inflammation brings its proven efficacy and long-term safety profile to yet another vulnerable population in need.”
In the US, the supplemental biologics license application for Dupixent has been accepted for review in certain children aged two to 11 years with CSU. Dupixent is currently approved for CSU in certain adults and adolescents in many jurisdictions, including the US and Japan.
*Adverse reactions in adults and adolescents were pooled from Study A, Study B, and Study C. Study B evaluated Dupixent in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite antihistamine use.
About CSU
CSU is a chronic, inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1AH, medicines that target H1 receptors on cells to control symptoms of itch and urticaria. However, the disease remains uncontrolled despite H1AH treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life.
About the Dupixent CSU phase 3 study program
The LIBERTY-CUPID phase 3 program evaluating Dupixent for CSU in children aged two to 11 years includes Study A, Study C, and CUPIDKids. CUPIDKids was a single arm clinical study that assessed the safety, efficacy, and pharmacokinetics of Dupixent in children aged two to 11 years with CSU who remained symptomatic despite the use of antihistamines. During the 24-week treatment period, Dupixent was administered at 200 mg every two (Q2W) or four weeks (Q4W) or 300 mg Q4W, with or without an initial loading dose, based on age and weight. The primary endpoint measured the serum concentration of Dupixent over time, including Ctrough (lowest concentration before the next dose) at Week 12 and Week 24.
Study A and Study C were replicate, double-blind, placebo-controlled clinical studies that assessed Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone in patients aged six years and older who remained symptomatic despite the use of antihistamines and were naïve to anti-IgE therapy. During the 24-week treatment period in both studies, all patients received an initial loading dose followed by either 300 mg Dupixent Q2W, or for pediatric patients weighing 30 kg to <60 kg, 200 mg Q2W. In both studies, endpoints assessed at Week 24 included:
| • | Change from baseline in itch and hives (weekly urticaria activity score [UAS7], 0-42 scale) the primary endpoint |
| • | Change from baseline in itch (measured by the weekly itch severity score, 0-21 scale), the key secondary endpoint |
| • | Change from baseline in hives (measured by the weekly hive severity score, 0-21 scale), secondary endpoint |
| • | Proportion of patients achieving well-controlled disease status (UAS7 ≤6) |
| • | Proportion of patients with complete response (UAS7=0) |
About Dupixent
Dupixent (dupilumab) is an injection administered under the skin (subcutaneous injection) at different injection sites. In children aged two to 11 years with CSU who remain symptomatic despite H1AH treatment, Dupixent is administered based on age and weight. In children aged two to five years, Dupixent is administered at 200 mg Q4W for patients weighing ≥5 kg to <15 kg and 300 mg Q4W for ≥15 kg to <30 kg, without an initial loading dose. In children and adolescents aged six to 17 years, Dupixent is administered at 300 mg Q4W for ≥15 kg to <30 kg,** 200 mg Q2W for ≥30 kg to <60kg, and 300mg Q2W for ≥60 kg, after an initial loading dose. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home after training by a healthcare professional. In children aged two to 11 years, Dupixent should be administered by a caregiver if given at home.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.
Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, CSU, chronic obstructive pulmonary disease, bullous pemphigoid, and allergic fungal rhinosinusitis in different age populations. More than 1.4 million patients are being treated with Dupixent globally.
**For children and adolescents aged six to 17 years weighing 15 kg to <30 kg, the initial dose is 300 mg on Day 1 followed by 300 mg on Day 15. Subsequent doses are initiated four weeks after Day 15.
Dupilumab development program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 12,000 patients with various chronic diseases driven in part by type 2 inflammation.
In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.
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 | 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
Sanofi 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
Regeneron Media Relations
Kailey Kilmartin | +1 914-652-0679| kailey.kilmartin@regeneron.com
Regeneron Investor Relations
Mark Hudson | +1 914-847-3482 | mark.hudson@regeneron.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 VelociSuite and Regeneron Genetics Center.
Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria in children aged 2 years and above; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, including Dupixent for the treatment of chronic pruritus of unknown origin, lichen simplex chronicus, and other potential indications; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products (such as Dupixent) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron’s business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney’s Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).