Sanofi (NASDAQ: SNY) ends amlitelimab in atopic dermatitis trials
Rhea-AI Filing Summary
Sanofi reported two July 2026 updates. One outlines an evolution of the Executive Committee effective September 1, 2026, with leadership changes across regional roles and global functions. Madeleine Roach will become President and Country Lead for Germany, Switzerland and Austria, with her current business operations responsibilities folded into Finance, whose remit will expand to include Global Partnering and Business Development. Thomas Triomphe will add responsibility for China alongside Vaccines leadership, while Olivier Charmeil moves to Strategic Projects Advisor to the CEO and Roy Papatheodorou, Executive Vice President and General Counsel, will leave after over four years.
The other update announces discontinuation of clinical development of amlitelimab in moderate-to-severe atopic dermatitis and a decision not to submit the drug for global regulatory reviews, after determining that the totality of efficacy and safety evidence would not deliver a meaningful improvement over current standard of care. Ongoing atopic dermatitis studies will be wound down with patient transition plans, but a phase 2 study of amlitelimab in celiac disease continues, with results expected in the second half of 2026. Sanofi is not changing its full-year 2026 guidance following this decision.
Positive
- None.
Negative
- None.
Key Figures
Key Terms
Executive Committee regulatory
moderate-to-severe atopic dermatitis medical
long-term extension study medical
monoclonal antibody medical
standard of care medical
full-year 2026 guidance financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What leadership changes did Sanofi (SNY) announce for its Executive Committee?
What decision did Sanofi (SNY) make about amlitelimab in atopic dermatitis?
How does discontinuing amlitelimab in atopic dermatitis affect Sanofi (SNY) guidance?
What is the status of Sanofi (SNY)'s amlitelimab program in celiac disease?
What did Sanofi (SNY) say about the ESTUARY study in atopic dermatitis?
Which executives are changing roles or leaving 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 July 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 July 2026, Sanofi published the press releases attached hereto as Exhibit 99.1 and 99.2 which is incorporated herein by reference.
Exhibit Index
| Exhibit No. |
Description | |
| Exhibit 99.1 | Press Release dated July 21, 2026: Sanofi evolves its Executive Committee to support its next strategic chapter | |
| Exhibit 99.2 | Press Release dated July 24, 2026: Sanofi announces decision not to submit amlitelimab in atopic dermatitis for global regulatory reviews | |
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: July 27, 2026 | SANOFI |
| By |
/s/ Alexandra Roger | |
| Name: Alexandra Roger | ||
| Title: Head of Legal Corporate & Finance |
3
Exhibit 99.1
| Press Release
|
|
Sanofi evolves its Executive Committee to support its next strategic chapter
Paris, July 21, 2026. Sanofi today announced an evolution of its Executive Committee, bringing together a focused leadership team across its businesses, scientific organization and key global functions as the company continues to deliver on its priorities and prepares its next strategic chapter.
Effective September 1, 2026, Sanofi’s Executive Committee will comprise:
| • | François Roger, Executive Vice President, Finance |
| • | Paulo Fontoura, Executive Vice President, Head of Research & Development |
| • | Manuela Buxo, Executive Vice President, Specialty Care |
| • | Thomas Triomphe, Executive Vice President, Vaccines |
| • | Thomas Grenier, Executive Vice President, General Medicines |
| • | Brendan O’Callaghan, Executive Vice President, Manufacturing & Supply |
| • | Jamie Haney, Executive Vice President, General Counsel |
| • | Véronique Jaillet, Executive Vice President, Chief People Officer, ad interim |
Emmanuel Frenehard, Head of Digital and Audrey Duval, Head of Corporate Affairs and President of Sanofi France, will continue to report directly to Belén Garijo, Sanofi’s CEO.
Madeleine Roach, currently Head of Business Operations, will become President and Country Lead of Sanofi Germany, Switzerland and Austria. Her current responsibilities, which focus on optimizing enterprise business services, will be integrated into the Finance function. Finance’s expanded remit will also include Global Partnering and Business Development, helping drive a more integrated approach across Business Development and Mergers & Acquisitions.
Thomas Triomphe will also assume responsibility for China, alongside his role as Executive Vice President, Vaccines.
Olivier Charmeil, currently Executive Vice President, General Medicines, will transition to Strategic Projects Advisor to the CEO. Throughout his career, Olivier has helped shape the company across a succession of leadership roles, with a deep and enduring commitment to its people, its business and the patients it serves. Roy Papatheodorou, currently Executive Vice President, General Counsel, has decided to leave the organization to pursue external opportunities after over four years with the company, during which he has brought outstanding leadership and contributions which went beyond his role as General Counsel.
“This Executive Committee brings together experienced professionals who will work together to help shape our future direction, make disciplined choices, execute them with focus, and ensure we continue to deliver for our patients, our people and all our stakeholders. I would like to thank all those who have contributed to Sanofi’s success and those who will continue to shape its future. I am deeply grateful for their leadership, commitment and dedication, and I wish everyone every success for the future,” said Belén Garijo, Chief Executive Officer of Sanofi.
Biographies and pictures available on sanofi.com or upon request.
About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com
Laura Romby| +33 6 74 16 74 29 | laura.romby@sanofi.com
Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pescheva@sanofi.com
Victor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Investor Relations
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Nina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com
Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com
Sanofi Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future events and economic performance. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” “attempt,” “target,” “project,” “strategy,” “strive,” “desire,” “predict,” “forecast,” “ambition,” “guideline,” “seek,” “should,” “will,” “goal,” or the negative of these, and similar expressions are intended to identify forward-looking statements. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the U.S Food and Drug Administration or the European Medicines Agency, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates; the fact that product candidates if approved may not be commercially successful; unexpected regulatory actions or delays, or government regulation generally; authorities’ decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including “most favored nation” pricing for State Medicaid programs; the future approval and commercial success of therapeutic alternatives; Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation; trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markets Authority (AMF) made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein.
|
|
2/2 |
Exhibit 99.2
| Press Release
|
|
Sanofi announces decision not to submit amlitelimab in atopic dermatitis for global regulatory reviews
Paris, July 24, 2026. Sanofi today announced the discontinuation of clinical development of amlitelimab, an OX40-ligand monoclonal antibody, in moderate-to-severe atopic dermatitis (AD). This decision not to submit for global regulatory reviews was made as part of an ongoing strategic assessment of the pipeline.
Sanofi has determined that the totality of efficacy and safety evidence generated to date does not support further development of amlitelimab in AD. While the ESTUARY phase 3 long-term extension study (clinical study identifier: NCT06407934) showed long-term maintenance of clinical response without relapse in patients aged 12 years and older with moderate-to-severe AD and an emerging safety profile that builds on previous data, amlitelimab would not represent a meaningful improvement to the standard of care for patients with AD. Additional results from the amlitelimab development program in AD, including from the ESTUARY study, will be presented at a forthcoming medical meeting.
Patients and their physicians need additional effective treatments due to the heterogeneity of underlying immune mechanisms that contribute to AD, and Sanofi remains committed to pursuing advances in inflammatory skin conditions.
Sanofi is deeply grateful to the patients, caregivers, and investigators who supported the development of amlitelimab in AD, including in the ESTUARY study. Sanofi will work closely with investigators, site teams, and regulatory authorities to ensure a wind-down of ongoing amlitelimab AD studies, with appropriate transition of care for all enrolled patients.
Financial considerations
Sanofi is not amending its full-year 2026 guidance as a result of this announcement.
About amlitelimab
Amlitelimab (SAR445229, KY1005) is a fully human, non-T cell depleting monoclonal antibody that blocks the OX40L, a key immune regulator. With its novel mechanism of action, amlitelimab selectively blocks OX40L signaling during the inflammatory prequel, the initiating phase of an overactive immune system, to potentially normalize T-cell-mediated inflammation without T-cell depletion.
The phase 2 study of amlitelimab in celiac disease is ongoing and expected to readout in the second half of 2026.
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 | +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
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
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 ForwardLooking 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.