Welcome to our dedicated page for Sanofi FR SEC filings (Ticker: SNYNF), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The SEC filings page for SANOFI ORD (SNYNF) provides access to Sanofi’s disclosures as a foreign private issuer under the Securities Exchange Act of 1934. Sanofi files annual reports on Form 20-F and current reports on Form 6-K pursuant to Rule 13a-16 or 15d-16, furnishing information that it makes public in its home market or through stock exchanges.
Sanofi’s Form 6-K filings incorporate press releases as exhibits, which describe regulatory and clinical events across several therapeutic areas. For example, exhibits reference Tzield as a disease-modifying therapy for adult and pediatric patients with stage 2 type 1 diabetes approved in China, and Dupixent, developed with Regeneron, which advanced in the European Union with a positive CHMP opinion for chronic spontaneous urticaria.
Other filings highlight an update on U.S. regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis, fast track designation in the United States for SAR402663 in neovascular age-related macular degeneration, and positive phase 2a results for brivekimig in hidradenitis suppurativa. These documents show how Sanofi reports on regulatory designations, approvals, and clinical trial outcomes to U.S. investors.
On this page, users can review Sanofi’s Forms 6-K and related exhibits as they appear in the EDGAR system. AI-powered summaries can help explain the focus of each filing, highlight the therapies and indications mentioned, and clarify the significance of regulatory terms such as fast track designation or positive CHMP opinion, making the content more accessible to readers who are not specialists in regulatory language.
Sanofi reported strong 2025 growth with a rich pipeline and active capital return. Net sales reached €43,626 million, up 9.9% at constant exchange rates, led by Dupixent (€15,714 million, +25.2%) and new pharma launches (€3,911 million, +47.9%). Business EPS rose to €7.83, up 15.0% at constant exchange rates, while free cash flow was €8,089 million.
In Q4 2025, sales were €11,303 million (+13.3% at constant exchange rates) and business EPS was €1.53 (+26.7% at constant exchange rates), showing margin expansion from a shift toward specialty medicines. IFRS EPS was -€0.66 in the quarter, mainly reflecting large intangible impairments including tolebrutinib.
Sanofi completed a €5 billion share buyback and proposes a €4.12 dividend for 2025, its 31st consecutive increase, and plans a €1 billion buyback in 2026. It closed the $1.2 billion Vicebio acquisition, agreed to acquire Dynavax for about $2.2 billion, and generated €10.4 billion net cash from the Opella consumer health separation. For 2026, Sanofi expects sales to grow by a high single-digit percentage at constant exchange rates with business EPS growing slightly faster, and sees profitable growth continuing for at least five years.
Sanofi reported new late-stage clinical results for amlitelimab, an experimental antibody targeting OX40-ligand for patients 12 and older with moderate-to-severe atopic dermatitis.
Two global phase 3 trials, SHORE and COAST 2, showed that amlitelimab given every four or twelve weeks improved skin clearance and disease severity at Week 24 versus placebo on key measures such as vIGA-AD 0/1 and EASI-75, with a safety profile similar to placebo in both studies. In COAST 2, amlitelimab met the primary endpoint for the US estimand but did not achieve statistical significance on co-primary endpoints for the EU estimand.
A preliminary analysis of the open-label ATLANTIS phase 2 study showed progressive improvement in vIGA-AD 0/1 from 35.4% at Week 24 to 50.3% at Week 52 and EASI-75 from 62.9% to 76.5%, with low discontinuations and serious adverse events. Sanofi plans global regulatory submissions for amlitelimab in the second half of 2026, while emphasizing that the drug remains under clinical development and is not yet approved.
Sanofi filed a report summarizing two regulatory milestones from September 2025. The company notes a press release on a positive CHMP opinion in the European Union for Dupixent, developed with Regeneron, for treating chronic spontaneous urticaria. A second press release covers an update on the U.S. regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis. The report itself mainly serves to formally furnish these press releases to investors.
Sanofi reported three corporate press developments in September 2025 affecting its late-stage pipeline. On September 10, 2025, Tzield was approved in China as the first disease-modifying therapy for adult and pediatric patients with stage 2 type 1 diabetes, marking a regulatory milestone for that indication in China. On September 11, 2025, Sanofi announced that SAR402663 received fast track designation in the U.S. for neovascular age-related macular degeneration, which can accelerate development and review. On September 17, 2025, Sanofi reported positive phase 2a results for brivekimig in hidradenitis suppurativa. The report is signed by Alexandra Roger, Head of Legal Corporate & Finance.