# EDGAR Filing Document

**Accession Number:** 0001121404
**File Stem:** 0001193125-25-154381
**Filing Date:** 2025-7
**Character Count:** 20845
**Document Hash:** 7ae6d664185d1e7353db81adee82e45e
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-154381.hdr.sgml**: 20250702

**ACCESSION NUMBER**: 0001193125-25-154381

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 5

**CONFORMED PERIOD OF REPORT**: 20250702

**FILED AS OF DATE**: 20250702

**DATE AS OF CHANGE**: 20250702

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Sanofi
- **CENTRAL INDEX KEY:** 0001121404
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 133529324
- **STATE OF INCORPORATION:** I0
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-31368
- **FILM NUMBER:** 251098394

**BUSINESS ADDRESS:**
- **STREET 1:** 46 AVENUE DE LA GRANDE ARMEE
- **CITY:** PARIS
- **STATE:** I0
- **ZIP:** 75017
- **BUSINESS PHONE:** 33153774400

**MAIL ADDRESS:**
- **STREET 1:** 46 AVENUE DE LA GRANDE ARMEE
- **CITY:** PARIS
- **STATE:** I0
- **ZIP:** 75017

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** SANOFI-AVENTIS
- **DATE OF NAME CHANGE:** 20040826

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** SANOFI SYNTHELABO SA
- **DATE OF NAME CHANGE:** 20010104

**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 2025

Commission File Number: 001-31368

**SANOFI** 

(Translation of registrant's name into English)

46, avenue de la Grande Armée, 75017 Paris, FRANCE

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

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In June 2025, Sanofi published the press releases attached hereto as Exhibits 99.1 and 99.2 which are incorporated herein by reference.

**Exhibit Index** 

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| | |
|:---|:---|
| <u>Exhibit No.</u> | <u>Description</u> |
| Exhibit 99.1 | [Press Release dated June 25, 2025: Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation](d27662dex991.htm) |
| Exhibit 99.2 | [Press Release dated June 30, 2025: Riliprubart granted orphan drug designation in Japan for chronic inflammatory demyelinating polyneuropathy](d27662dex992.htm) |

---

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

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| | | | |
|:---|:---|:---|:---|
| Dated: July 2, 2025 | SANOFI | SANOFI | SANOFI |
|  | By | /s/ | Alexandra Roger |
|  |  | Name: Alexandra Roger | Name: Alexandra Roger |
|  |  | Title: Head of Legal Corporate & Finance | Title: Head of Legal Corporate & Finance |

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## Exhibit 99.1

**Exhibit 99.1** 

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| | |
|:---|:---|
| **Press Release** | ![LOGO](g27662g0618022340665.jpg) |

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*Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation* 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Ongoing phase 2 study evaluating riliprubart for the potential prevention and treatment of active antibody-mediated
rejection in kidney transplant recipients

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Riliprubart was also designated orphan drug for the investigational use in chronic inflammatory demyelinating
polyneuropathy in the US and EU

**Paris, June 25, 2025**. The US Food and Drug Administration (FDA) has granted orphan drug designation to riliprubart for the investigational treatment of antibody-mediated rejection (AMR) in solid organ transplantation. This designation reflects Sanofi's commitment to addressing a critical unmet need in transplant medicine, where AMR remains a significant challenge with no FDA-approved treatments available. The FDA grants orphan drug designation to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the US.

***Alyssa Johnsen***

Global Therapeutic Area Development Head, Immunology and Inflammation, Sanofi

*"Orphan drug designation for riliprubart marks an important milestone in our mission to address critical challenges in transplant medicine leveraging our expertise in immunology. Antibody mediated rejection represents a serious threat to transplanted organs and patient survival. Through riliprubart's innovative mechanism of action, we hope to bring forward a treatment option that could significantly improve outcomes for kidney transplant recipients."* 

Riliprubart is currently being explored in multiple clinical studies across different indications in transplant and neurology. A phase 2 clinical study is currently ongoing, exploring its potential in kidney transplant recipients (<u>NCT05156710</u>). The study includes two patient cohorts: those at risk of developing rejection and those with active forms of antibody-mediated rejection. In addition, Sanofi is conducting two phase 3 studies exploring riliprubart in chronic inflammatory demyelinating polyneuropathy (CIPD), a rare neurological disorder, specifically in patients refractory to standard of care (MOBILIZE, clinical study identifier: <u>NCT06290128</u>), and in IVIg-treated patients (VITALIZE, clinical study identifier: <u>NCT06290141</u>). The broad clinical development program for riliprubart emphasizes Sanofi's commitment to exploring riliprubart's potential across multiple immune-mediated conditions with high unmet medical needs.

*About Riliprubart* 

SAR445088 (riliprubart) is a potential first-in-class, IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway of the innate immune system. Riliprubart is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. For more information on riliprubart clinical studies, please visit <u>www.clinicaltrials.gov</u>.

*About AMR* 

Antibody-mediated rejection is a serious complication that may arise after solid organ transplantation, occurring when the recipient's immune system produces antibodies that attack the transplanted organ. Sensitized recipients, who have pre-existing antibodies that target foreign antigens including those found on transplanted organs, face a high risk of developing antibody-mediated rejection. Subsequent immune response can lead to inflammation, organ damage, and organ failure if left untreated.

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|:---|:---|
| ![LOGO](g27662g39w89.jpg) | 1/2 |

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*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 \| <u>sandrine.guendoul@sanofi.com</u>

**Evan Berland** \| +1 215 432 0234 \| <u>evan.berland@sanofi.com</u>

**Léo Le Bourhis** \| +33 6 75 06 43 81 \| <u>leo.lebourhis@sanofi.com</u>

**Victor Rouault** \| +33 6 70 93 71 40 \| <u>victor.rouault@sanofi.com</u>

**Timothy Gilbert** \| +1 516 521 2929 \| <u>timothy.gilbert@sanofi.com</u>

**Léa Ubaldi** \| +33 6 30 19 66 46 \| <u>lea.ubaldi@sanofi.com</u>

*Investor Relations* 

**Thomas Kudsk Larsen** \| +44 7545 513 693 \| <u>thomas.larsen@sanofi.com</u>

**Alizé Kaisserian** \| +33 6 47 04 12 11 \| <u>alize.kaisserian@sanofi.com</u>

**Felix Lauscher** \| +1 908 612 7239 \| <u>felix.lauscher@sanofi.com</u>

**Keita Browne** \| +1 781 249 1766 \| <u>keita.browne@sanofi.com</u>

**Nathalie Pham** \| +33 7 85 93 30 17 \| <u>nathalie.pham@sanofi.com</u>

**Tarik Elgoutni** \| +1 617 710 3587 \| <u>tarik.elgoutni@sanofi.com</u>

**Thibaud Châtelet** \| +33 6 80 80 89 90 \| <u>thibaud.chatelet@sanofi.com</u>

**Yun Li** \| +33 6 84 00 90 72 \| <u>yun.li3@sanofi.com</u>

**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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|:---|:---|
| ![LOGO](g27662g39w89.jpg) | 2/2 |

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## Exhibit 99.2

**Exhibit 99.2** 

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| | |
|:---|:---|
| **Press Release** | ![LOGO](g27662g0618022340665.jpg) |

---

*Riliprubart granted orphan drug designation in Japan for* 

*chronic inflammatory demyelinating polyneuropathy* 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Two phase 3 studies are currently underway testing riliprubart in people with CIDP as a potential first-in-class treatment

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Japanese Ministry of Health, Labour and Welfare decision adds to similar designations in the US and Europe,
underscoring global regulatory recognition of the potential for riliprupart to address significant unmet medical needs for people living with this rare neurological condition

**Paris, June 30, 2025**. The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted orphan drug designation to riliprubart, a monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway for people with chronic inflammatory demyelinating polyneuropathy (CIDP). Despite available therapies, many CIDP patients are left with residual symptoms, including weakness, numbness, and fatigue that can lead to long-term morbidity and diminished quality of life. Approximately 30% of people with CIDP do not respond to standard therapies. The MHLW grants orphan drug designation to medicines that address rare medical diseases or conditions with unmet medical needs. There are currently approximately 4,000 people diagnosed with CIDP in Japan.

***Erik Wallstroem, MD, PhD***

Global Head of Neurology Development, Sanofi

*"The orphan drug designation of riliprubart for people living with CIDP in Japan underscores our commitment to applying our deep understanding of the immune system to address rare neurological disorders with significant unmet medical needs. While CIDP therapies exist, many individuals continue to experience debilitating symptoms, including pain, fatigue and weakness. Our ongoing development of riliprubart reflects our dedication to challenging the status quo in neurology with the goal of improving people's lives."* 

Long-term, 76-week sustained efficacy and safety data from riliprubart's phase 2 study were presented at the <u>Peripheral Nerve Society</u> meeting in Edinburgh, UK on May 17-20, 2025. Findings suggest a potential sustained long-term benefit provided by riliprubart across a broad spectrum of participants with CIDP. Riliprubart is currently being tested in two separate phase 3 studies: MOBILIZE in patients refractory to standard of care (clinical study identifier: NCT06290128) and VITALIZE in IVIg-treated patients (clinical study identifier: NCT06290141).

*About riliprubart* 

SAR445088 (riliprubart) is an IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway of the innate immune system. By blocking C1s, riliprubart has the potential to inhibit key inflammatory mechanisms that drive demyelination and axonal damage in CIDP. Riliprubart is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. For more information on riliprubart clinical studies, please visit <u>www.clinicaltrials.gov</u>.

*About CIDP* 

CIDP is a rare neurological condition that causes progressive weakness and sensory impairment in the arms and legs. CIDP occurs when the body's immune system attacks the myelin sheaths around nerve cells in the peripheral nervous system. Timely diagnosis of CIDP is important because it allows for appropriate treatment, which is essential to preventing long-term disability. However, despite available therapies, many individuals are left with residual symptoms, including weakness, numbness, and fatigue that can lead to long-term morbidity and diminished quality-of-life. Approximately 30% of people with CIDP do not respond to standard therapies. In people with CIDP who do respond, about 70% of the response is considered incomplete. Less than one-third of people with CIDP remain in remission without continued therapy.

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|:---|:---|
| ![LOGO](g27662g39w89.jpg) | 1/2 |

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------

*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 \| <u>sandrine.guendoul@sanofi.com</u>

**Evan Berland** \| +1 215 432 0234 \| <u>evan.berland@sanofi.com</u>

**Léo Le Bourhis** \| +33 6 75 06 43 81 \| <u>leo.lebourhis@sanofi.com</u>

**Victor Rouault** \| +33 6 70 93 71 40 \| <u>victor.rouault@sanofi.com</u>

**Timothy Gilbert** \| +1 516 521 2929 \| <u>timothy.gilbert@sanofi.com</u>

**Léa Ubaldi** \| +33 6 30 19 66 46 \| <u>lea.ubaldi@sanofi.com</u>

*Investor Relations* 

**Thomas Kudsk Larsen** \|+44 7545 513 693 \| <u>thomas.larsen@sanofi.com</u>

**Alizé Kaisserian** \| +33 6 47 04 12 11 \| <u>alize.kaisserian@sanofi.com</u>

**Felix Lauscher** \| +1 908 612 7239 \| <u>felix.lauscher@sanofi.com</u>

**Keita Browne** \| +1 781 249 1766 \| <u>keita.browne@sanofi.com</u>

**Nathalie Pham** \| +33 7 85 93 30 17 \| <u>nathalie.pham@sanofi.com</u>

**Tarik Elgoutni** \| +1 617 710 3587 \| <u>tarik.elgoutni@sanofi.com</u>

**Thibaud Châtelet** \| +33 6 80 80 89 90 \| <u>thibaud.chatelet@sanofi.com</u>

**Yun Li** \| +33 6 84 00 90 72 \| <u>yun.li3@sanofi.com</u>

**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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| ![LOGO](g27662g39w89.jpg) | 2/2 |

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