Sanofi wins FDA accelerated approval for Tzield

Sanofi reports that the US FDA has granted accelerated approval to Tzield (teplizumab-mzwv) to delay the decline of natural insulin production in children aged eight to 17 years recently diagnosed with stage 3 type 1 diabetes.

Rhea-AI Filing Summary

Sanofi reports that the US FDA has granted accelerated approval to Tzield (teplizumab-mzwv) to delay the decline of natural insulin production in children aged eight to 17 years recently diagnosed with stage 3 type 1 diabetes. This makes Tzield the first disease-modifying therapy for autoimmune type 1 diabetes in this setting.

The decision is based on the phase 3 PROTECT study, where Tzield significantly slowed the decrease in C-peptide, a marker of beta cell function, compared with placebo, and on data from more than 900 treated patients. Approval is conditional on confirmation of clinical benefit in the ongoing BETA-PRESERVE phase 3 study.

Positive

• FDA accelerated approval for new Tzield indication: Tzield received accelerated approval in the US to delay decline in endogenous insulin production in children aged eight to 17 years with recently diagnosed stage 3 type 1 diabetes, establishing it as the first disease-modifying therapy for autoimmune T1D in this setting.

Negative

• None.

Insights

Biopharma regulatory analyst

FDA accelerated approval of Tzield adds a new disease‑modifying option in stage 3 type 1 diabetes.

The FDA granted accelerated approval for Tzield in children eight to 17 with recently diagnosed stage 3 type 1 diabetes, based on the phase 3 PROTECT trial. Tzield significantly slowed the decline in C-peptide, indicating preservation of insulin-producing beta cell function.

This approval builds on prior indications in stage 2 disease and confirms Tzield as the first disease-modifying therapy in autoimmune type 1 diabetes. The label notes common adverse reactions and serious risks such as cytokine release syndrome and viral reactivation, especially in immunocompromised patients.

Because approval is conditional, continued market access depends on confirming clinical benefit in the BETA-PRESERVE phase 3 study, which is enrolling. Outcomes from this study and any additional safety data discussed in future periodic reports will be central to understanding the long-term impact of this therapy.

Key Figures

Annual T1D diagnoses: 64,000 people per year C-peptide LS mean difference: 0.13 pmol/mL C-peptide confidence interval: 0.09–0.17 pmol/mL +5 more

8 metrics

Annual T1D diagnoses 64,000 people per year Approximate annual type 1 diabetes diagnoses referenced by Breakthrough T1D CEO

C-peptide LS mean difference 0.13 pmol/mL PROTECT phase 3 primary endpoint difference vs placebo

C-peptide confidence interval 0.09–0.17 pmol/mL 95% confidence interval for LS mean difference in PROTECT trial

PROTECT enrollment 328 participants Children and adolescents aged eight to 17 years with stage 3 T1D

Treatment allocation 217 Tzield / 111 placebo Randomization in PROTECT phase 3 study (2:1 ratio)

Infusion courses 2 × 12 daily infusions Initial and 26-week courses of Tzield or placebo in PROTECT

Eligible age range 8–17 years Children and adolescents targeted in new stage 3 T1D indication

US rare disease threshold Fewer than 200,000 people Criterion for FDA orphan drug designation referenced for Tzield

Key Terms

accelerated approval, stage 3 type 1 diabetes, C-peptide, breakthrough therapy, +2 more

6 terms

accelerated approval regulatory

"The US Food and Drug Administration (FDA) has granted accelerated approval to Tzield"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

stage 3 type 1 diabetes medical

"patients recently diagnosed with stage 3 type 1 diabetes"

Stage 3 type 1 diabetes is the clinical, symptomatic phase of an autoimmune disease in which the body can no longer make enough insulin, causing persistently high blood sugar and requiring ongoing insulin therapy. For investors this stage matters because it defines the patient population that needs chronic treatment, shapes clinical trial goals and regulatory requirements, and helps estimate long‑term market demand—think of it as the point when a warning light becomes an urgent service call.

C-peptide medical

"slowing the decrease in mean C-peptide levels (area under the curve"

C‑peptide is a short protein fragment released at the same time the pancreas produces insulin; because it lingers in the blood longer than insulin itself, clinicians measure C‑peptide levels as a clear sign of how much natural insulin a person still makes. For investors, C‑peptide matters because it’s used as a measurable outcome in diabetes drug and device trials, in diagnostic tests, and by regulators to judge treatment benefit — results that can affect clinical success, approvals, and market value.

breakthrough therapy regulatory

"Tzield was previously designated by the FDA as breakthrough therapy"

A breakthrough therapy is a regulatory designation granted to an experimental drug or treatment when early clinical evidence indicates it could offer a substantial improvement over existing options for a serious or life‑threatening condition. For investors it matters because the label brings faster, more intensive interaction with regulators and can shorten development and review time—like a VIP fast‑track toward potential approval, reducing time and risk before a product can reach the market.

orphan drug designation regulatory

"and was granted orphan drug designation, for investigational medicines that treat rare diseases"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

cytokine release syndrome medical

"Serious events such as cytokine release syndrome and life-threatening cases of viral reactivation"

An intense immune overreaction in which the body's defense system releases a large surge of signaling proteins, causing fever, low blood pressure, breathing trouble or organ stress; imagine the immune system's alarm going into overdrive and flooding the body with emergency responders. Investors care because this side effect can slow or block regulatory approval, increase clinical trial costs and liabilities, limit how widely a therapy can be used, and therefore affect a drug's market value and sales potential.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Sanofi (SNY) announce about Tzield in the US?

Sanofi announced US FDA accelerated approval for Tzield to delay decline of endogenous insulin production in children aged eight to 17 with recently diagnosed stage 3 type 1 diabetes. This makes Tzield the first disease-modifying therapy for autoimmune type 1 diabetes in this clinical stage.

What clinical data supported Sanofi (SNY) Tzield’s new approval?

The approval is supported by the PROTECT phase 3 trial, where Tzield significantly slowed the decrease in mean C-peptide levels versus placebo, with a least-squares mean difference of 0.13 pmol/mL (95% CI 0.09–0.17; p<0.001). Additional safety and efficacy data from over 900 treated patients also contributed.

Which patients are eligible for Sanofi (SNY) Tzield under this indication?

Tzield is indicated to delay decline in endogenous insulin production in children aged eight to 17 years recently diagnosed with stage 3 type 1 diabetes. All participants in the pivotal study also received standard-of-care medicines, reflecting use alongside established insulin-based management approaches.

What are key risks and side effects of Sanofi (SNY) Tzield?

Common adverse reactions include lymphopenia, vomiting, rash, leukopenia, diarrhea, neutropenia, increased liver transaminase, and headache. Serious events such as cytokine release syndrome and life-threatening viral reactivation have been reported, with immunocompromised patients at increased risk for viral reactivation requiring careful monitoring and clinical judgment.

Is Sanofi (SNY) Tzield’s new indication fully approved or conditional?

The indication is granted under accelerated approval, based on a surrogate endpoint of reduced C-peptide decline. Continued approval may depend on verifying and describing clinical benefit in confirmatory studies, including the ongoing BETA-PRESERVE phase 3 trial that is currently enrolling participants globally.

How does this Tzield approval fit with Sanofi (SNY) global indications?

Before this stage 3 approval, Tzield was approved to delay onset of stage 3 type 1 diabetes in stage 2 patients in the US and multiple countries, including the UK, EU, China, Australia, Canada, and others. The new label extends Sanofi’s autoimmune T1D franchise into recently diagnosed stage 3 disease in US children.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 06/22/2026 - 08:43 AM EDT Learn about SEC filing dates

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 June 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 June 2026, Sanofi published the press release attached hereto as Exhibit 99.1 which is incorporated herein by reference.

Exhibit Index

Exhibit No.		Description
Exhibit 99.1		Press Release dated June 13, 2026: Sanofi’s Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes.

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: June 22, 2026 SANOFI

By		/s/ Alexandra Roger
		Name: Alexandra Roger
		Title: Head of Legal Corporate & Finance

3

Exhibit 99.1

Press Release

Sanofi’s Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes

● Accelerated approval in children aged eight to 17 years old recently diagnosed with stage 3 T1D to delay the decline in endogenous insulin production

● Approval based on the PROTECT phase 3 study and additional data from the global clinical development program from over 900 patients who received Tzield

Paris, June 13, 2026. The US Food and Drug Administration (FDA) has granted accelerated approval to Tzield (teplizumab-mzwv) to delay the decline in endogenous (own) insulin production in children aged eight to 17 years recently diagnosed with stage 3 T1D. Tzield is not effective as a disease-modifying therapy in non-autoimmune dysglycemic conditions.

“We now have a novel therapy that targets the autoimmune and progressive nature of stage 3 type 1 diabetes,” said Aaron J. Kowalski, PhD, CEO of Breakthrough T1D. “Approximately 64,000 people are diagnosed with T1D every year. We are excited that the approval of Tzield in this indication provides a treatment option for certain patients diagnosed in stage 3 T1D, which is when many start experiencing common symptoms of the disease.”

The approval was supported by data from the PROTECT phase 3 study (clinical study identifier: NCT03875729), evaluating beta cell function as assessed by significantly slowing the decrease in mean C-peptide levels (area under the curve after a four-hour, mixed-meal tolerance test; difference in least-squares means 0.13 pmol/mL; 95% confidence interval: 0.09-0.17; p<0.001) at trial completion, compared to placebo, as well as data from the broader clinical development program that included over 900 patients who received Tzield. Adverse events observed in the PROTECT phase 3 study were consistent with previous studies.

The most common adverse reactions were lymphopenia, vomiting, rash, leukopenia, diarrhea, neutropenia, increased liver transaminase, and headache. Serious events such as cytokine release syndrome and life-threatening cases of viral reactivation have been reported with Tzield. Patients who are immunocompromised are at increased risk for viral reactivation.

This indication is granted under accelerated approval based on evidence of reduced C-peptide decline. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory study(ies).

Medicines that receive accelerated approval are intended to treat serious conditions that fill an unmet medical need, based on a surrogate endpoint reasonably likely to predict clinical benefit. In line with this, the confirmatory BETA-PRESERVE phase 3 study (clinical study identifier: NCT07088068) was initiated and is currently enrolling participants.

“We welcome this accelerated approval by the FDA, which recognizes the potential of Tzield to delay the progression of recently diagnosed stage 3 T1D in children aged eight to 17 years,” said Christopher Corsico, Global Head of Development, Sanofi. “Tzield will now offer a new pathway in the treatment paradigm of stage 3 T1D, one that we hope will further enable healthcare providers in the US to take a more proactive approach to disrupt the underlying autoimmune attack against insulin-producing beta cells.”

Prior to this approval in recently diagnosed stage 3 T1D, in April 2026, the FDA expanded the indication to delay the onset of stage 3 T1D in adults and children eight years and older with stage 2 T1D, to include children aged one year and above. It is also approved to delay the onset of stage 3 T1D in adults and children eight years and older with stage 2 T1D in the UK, the EU (under the name Teizeild), China, Australia, Canada, Israel, Saudi Arabia, the UAE, Kuwait, Brazil and Switzerland. Regulatory reviews are ongoing in other jurisdictions around the world. Tzield was previously designated by the FDA as breakthrough therapy and was granted orphan drug designation, for investigational medicines that treat rare diseases affecting fewer than 200,000 people in the US.

About PROTECT

PROTECT was a phase 3, randomized, double blind, placebo-controlled, multinational study. It enrolled 328 children and adolescents (Tzield n=217, placebo n=111) aged eight to 17 years diagnosed with clinical stage 3 T1D in the preceding six weeks; randomization ratio of Tzield to placebo was 2:1. Participants received a first course of 12 daily infusions (of either Tzield or placebo) at randomization, followed by a second course of 12 daily infusions after 26 weeks (approximately six months). All participants received standard-of-care medicines as required.

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.

- 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.

About Tzield

Tzield (teplizumab) is a CD3-directed monoclonal antibody. Tzield is the first disease- modifying therapy in autoimmune T1D; it was approved in the US in November 2022 to delay the onset of stage 3 T1D in adults and children eight years and older diagnosed with stage 2 T1D. In April 2026, the FDA expanded this indication to include children aged one year and above. Today, it is also approved in to delay the onset of stage 3 T1D in adults and children eight years and older with stage 2 in the UK, the EU (under the name Teizeild), China, Australia, Canada, Israel, Saudi Arabia, the UAE, Kuwait, Brazil and Switzerland. Other regulatory reviews are ongoing.

About Sanofi

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations

Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com

Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com

Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com

Victor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com

Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com

Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com

Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com

Investor Relations

Thomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com

Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com

Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com

Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com

Nina Goworek | +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 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.

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