# EDGAR Filing Document

**Accession Number:** 0001121404
**File Stem:** 0001193125-26-014575
**Filing Date:** 2026-1
**Character Count:** 23967
**Document Hash:** 2181a0788312d2a141ae4a76baaab348
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-014575.hdr.sgml**: 20260116

**ACCESSION NUMBER**: 0001193125-26-014575

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 6

**CONFORMED PERIOD OF REPORT**: 20260116

**FILED AS OF DATE**: 20260116

**DATE AS OF CHANGE**: 20260116

**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:** 26537568

**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 January 2026

Commission File Number: 001-31368

**SANOFI** 

(Translation of registrant's name into English)

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

(Address of principal executive offices)

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

Form 20-F ☒ Form 40-F ☐

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In January 2026, 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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| | |
|:---|:---|
| Exhibit No. | Description |
| Exhibit 99.1 | [Press Release dated January 12, 2026: Sanofi's Teizeild approved in the EU for patients with stage 2 type 1 diabetes](d100861dex991.htm) |
| Exhibit 99.2 | [Press Release dated January 15, 2026: Myqorzo and Redemplo approved in China](d100861dex992.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: January 16, 2026 |  | SANOFI |
|  | By | /s/ <u>Alexandra Roger</u> |
|  |  | Name: Alexandra Roger |
|  |  | Title: Head of Legal Corporate & Finance |

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## Exhibit 99.1

**Exhibit 99.1** 

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| | |
|:---|:---|
| **Press Release** | ![LOGO](g100861g0115232645976.jpg) |

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*Sanofi's Teizeild approved in the EU for patients with stage 2 type 1 diabetes* 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Approval based on the TN-10 phase 2 study that demonstrated a significant delay
of onset of stage 3 T1D in stage 2 T1D patients

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Teizeild represents a potential significant change in the treatment of autoimmune T1D, preventing the natural disease
progression protecting beta-cell function

**Paris, January 12, 2026.** The European Commission has approved Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients eight years of age and older with stage 2 T1D. This follows the <u>positive opinion</u> by the European Medicines Agency's Committee for Medicinal Products for Human Use. Teizeild is the first T1D disease-modifying therapy approved in the EU, marking a significant milestone in the treatment of this progressive autoimmune disease. The approval is based on positive results from the TN-10 phase 2 study (clinical study identifier: <u>NCT01030861</u>) demonstrating that Teizeild delayed the onset of stage 3 T1D by a median of two years compared to placebo, in adults and children aged eight years and older with stage 2 T1D.

*"We are pleased that, for the first time, we will be able to offer patients and families in the EU a disease-modifying therapy designed to address the underlying immune process of type 1 diabetes,"* said **Olivier Charmeil,** Executive Vice President, General Medicines, Sanofi. *"We remain committed to working with external stakeholders across the EU to bring patients the benefits of Teizeild, a unique therapy that may prevent the natural progression of type 1 diabetes by protecting beta-cell function."*

At the end of the <u>TN-10</u> phase 2 study, the proportion of patients who remained in stage 2 T1D was almost twice as high in the Teizeild group as in the placebo group (57% vs 28%). The safety profile was consistent with the one observed in previous studies of Teizeild. The most frequently observed adverse events were blood or bone marrow-related (transient lymphopenia) in 75% of the participants and dermatologic or skin-related (rash) in 36% of the participants.

Teizeild (known as Tzield outside the EU) is also approved in the US, the UK, China, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait to delay the onset of stage 3 T1D in adults and children aged eight years and older with stage 2 T1D. As previously communicated, following the positive CHMP recommendation for this newly approved indication, Sanofi has decided not to progress with a second application for Teizeild in recently diagnosed stage 3 T1D at this time. Next steps are under evaluation. Other regulatory reviews are ongoing.

*About TN-10* 

The pivotal TN-10 phase 2 study was a randomized, placebo-controlled, double-blind study which evaluated Teizeild for the delay of stage 3 T1D in adults and children aged eight years and older diagnosed with stage 2 T1D (presence of at least two T1D-related autoantibodies and dysglycemia) who are relatives of people living with autoimmune T1D. Seventy-six participants aged eight to 45 were enrolled (Teizeild n=44, placebo n=32). They were randomized to receive a single 14-day course of either Teizeild or placebo.

The primary endpoint was the elapsed time from randomization to the clinical diagnosis of autoimmune stage 3 T1D (progression from stage 2 T1D to stage 3 T1D). Key secondary end points included safety and tolerability.

Results demonstrated that the median time to the diagnosis of stage 3 T1D was 48.4 months in the Teizeild group and 24.4 months in the placebo group. The disease was diagnosed in 19 (43%) of the participants who received Teizeild and in 23 (72%) of those who received placebo. The

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hazard ratio for the diagnosis of type 1 diabetes (Teizeild vs. placebo) was 0.41 (95% CI: 0.22 to 0.78; p=0.006 by adjusted Cox proportional-hazards model). There were expected adverse events of rash and transient lymphopenia.

*About Teizeild* 

Teizeild (teplizumab) is a CD3-directed monoclonal antibody. Teizeild is the first and only disease modifying therapy in autoimmune T1D; it was approved in the US in November 2022 to delay the onset of stage 3 type 1 diabetes in adults and children eight years and older diagnosed with stage 2 T1D. Today, it is also approved in the UK, China, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait for the same indication. Other regulatory reviews are ongoing.

*About autoimmune T1D* 

T1D is a progressive autoimmune disease where the body's ability to regulate blood sugar levels is impacted due to the gradual destruction of insulin producing beta cells by one's own immune system. There are four stages to the progression of T1D:

- In stage 1, the autoimmune attack to the beta cells has started, and this can be detected by the presence of 2 or more T1D-related autoantibodies in the blood. During stage 1, blood sugar levels are in a normal range (normoglycemia). At this stage, T1D is presymptomatic.

- In stage 2 (also presymptomatic), in addition to the presence of 2 or more T1D-related autoantibodies, blood sugar levels are now abnormal (dysglycemia) due to the progressive loss of beta cells / beta cell function.

Stage 3 (also known as clinical stage) comes once a significant portion of the beta cells have been destroyed. At this point, rising blood sugar levels reach the point of clinical hyperglycemia (which defines diabetes), and many people will start to experience the classic symptoms that come with the onset of stage 3 T1D: increased thirst, frequent urination, unexplained weight loss, blurred vision, and generalized fatigue. Management of stage 3 T1D requires daily and burdensome insulin replacement therapy. <br>

Stage 4 is defined as long-standing autoimmune T1D, often accompanied by evidence of chronic diabetic complications, where little to no beta-cell function remains (it's been estimated that beta-cell mass is reduced by up to 95%). At this point, the T1D-related autoantibodies might not be present anymore in the blood, as most beta-cells have been rendered useless by the autoimmune attack. <br>

*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 \| <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** \| +1 617 356 4751 \| <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>

**Ekaterina Pesheva** \| + 1 410 926 6780 <u>ekaterina.pesheva@sanofi.com</u>

*Sanofi 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>

**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>

**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>

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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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans", and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

All trademarks mentioned in this press release are the property of the Sanofi group.

## Exhibit 99.2

**Exhibit 99.2** 

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| | |
|:---|:---|
| <br> **Press Release** | ![LOGO](g100861g0116004144721.jpg) |

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*Myqorzo and Redemplo approved in China* 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Approval of Myqorzo for obstructive hypertrophic cardiomyopathy and Redemplo for familial chylomicronemia syndrome

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Underscores Sanofi's long-term commitment to China, reinforcing the ambition to provide transformative medicines
to patients in disease areas with large unmet medical needs

**Paris, January 15, 2026.** The National Medical Products Administration in China has approved two Sanofi-licensed innovative medicines, Myqorzo (aficamten*)* for the treatment of obstructive hypertrophic cardiomyopathy (oHCM), and Redemplo (plozasiran) for the reduction of triglyceride levels, in adult patients with familial chylomicronaemia syndrome (FCS) on the basis of dietary control.

"We are pleased to bring Myqorzo and Redemplo to patients in Greater China. Both medicines represent important advances in treatment options and address unmet medical needs among people living with complex conditions," said ***Olivier Charmeil***, Executive Vice President, General Medicines, Sanofi. "The latest approvals underscore Sanofi's long-term commitment to bringing innovative medicines to Chinese patients."

**Myqorzo** is a selective, small-molecule cardiac myosin inhibitor to improve functional capacity and relieve symptoms in patients with oHCM, in which the myocardium, the heart muscle, becomes abnormally thick. It is the most common monogenic inherited cardiovascular disorder. The approval was based on the positive pivotal SEQUOIA-HCM phase 3 study (clinical study identifier: <u>NCT05186818</u>) in patients with symptomatic oHCM.

**Redemplo** is a small-interfering RNA (siRNA) medicine, suppressing the production of apoc-III, an important target for reducing triglycerides in patients with FCS. FCS is a severe and rare disease where extremely high triglyceride levels can lead to various serious signs and symptoms including acute and potentially fatal pancreatitis, chronic abdominal pain, diabetes, hepatic steatosis, and cognitive issues. The approval was based on the positive pivotal PALISADE phase 3 study (clinical study identifier: <u>NCT05089084</u>) in patients with genetically confirmed or clinically diagnosed FCS.

*About HCM* 

HCM is the most common inherited cardiovascular disorder, characterized by abnormal thickening of the heart muscle (myocardium). This leads to the left ventricle becoming smaller and stiffer, impairing its ability to relax and fill with blood, limiting the heart's pumping function and exercise capacity. HCM symptoms include: chest pain, dizziness, shortness of breath, or fainting during physical activity.

HCM has two forms: oHCM (two-thirds of patients), where thickened muscle blocks blood flow, and non-obstructive HCM (one-third), where the muscle is thickened but blood flows normally. HCM patients face serious complications including atrial fibrillation, stroke, and mitral valve disease. It's a leading cause of sudden cardiac death in young people and athletes due to dangerous heart rhythm abnormalities. Some patients have a high risk of progressive diseases leading to dilated cardiomyopathy and heart failure requiring transplantation.

*About Myqorzo* 

Myqorzo (aficamten) is a selective, small-molecule cardiac myosin inhibitor discovered following an extensive chemical optimization program that was conducted with careful attention to therapeutic index and pharmacokinetic properties. Myqorzo was designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the

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|:---|:---|
| ![LOGO](g100861g1215174610493.jpg) | 1/3 |

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myocardial hypercontractility that is associated with HCM. In preclinical models, Myqorzo reduced myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state. Myqorzo is approved in the US and China.

Myqorzo, for the treatment of symptomatic oHCM, was designated breakthrough therapy and orphan drug in the US, and breakthrough therapy in China. On December 12, 2025, The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending marketing authorization in the EU with a final decision expected in the first quarter of 2026. In <u>December 2024</u>, Sanofi obtained exclusive rights to develop and commercialize Myqorzo in Greater China for treating both forms of HCM. These rights came through an agreement with Corxel Pharmaceuticals, who had acquired them from Cytokinetics.

*About FCS* 

FCS is a severe and rare disease leading to extremely high triglyceride levels, over 880 mg/dL (9.94 mmol/L). Such severe elevations can lead to various serious signs and symptoms including acute and potentially fatal pancreatitis, chronic abdominal pain, diabetes, hepatic steatosis, and cognitive issues.

*About Redemplo* 

Redemplo (plozasiran) is a siRNA medicine suppressing the production of apoC-III, a protein produced primarily in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting apoC-III with sustained silencing, Redemplo delivers significant reductions in triglyceride levels. Redemplo has been studied in both genetically confirmed and clinically diagnosed patients living with FCS. Redemplo, for the treatment of FCS, was designated breakthrough therapy, fast track, and orphan drug in the US, orphan in the EU, and breakthrough therapy in China. Redemplo is approved in the US, Canada, and China for the treatment of FCS patients. Regulatory review is ongoing in the EU.

In <u>August 2025</u>, Sanofi acquired the rights to develop and commercialize Redemplo in Greater China from Visirna Therapeutics, a majority-owned subsidiary of Arrowhead Pharmaceuticals.

*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>

**Ekaterina Pesheva** \| +1 410 926 6780 \| <u>ekaterina.pesheva@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>

**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>

**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 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.* 

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| ![LOGO](g100861g1215174610493.jpg) | 2/3 |

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 *Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.* 

*All trademarks mentioned in this press release are the property of the Sanofi group.* 

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| ![LOGO](g100861g1215174610493.jpg) | 3/3 |

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