Welcome to our dedicated page for Sanofi SEC filings (Ticker: SNY), 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.
Sanofi filings document a foreign biopharmaceutical issuer whose American depositary shares represent interests in ordinary shares. Its SEC record includes Form 6-K reports and Form 20-F annual reporting that incorporate parent-company press releases, financial reports, governance materials and ADR-related disclosure.
Sanofi’s filings cover operating results, research and development spending, product and pipeline updates, regulatory approvals and designations, and therapeutic areas such as immunology, vaccines, rare diseases, oncology, respiratory disease and diabetes. They also document bond issuance under its Euro Medium Term Note programme, share buyback activity, annual meeting resolutions, board and executive appointments, risk factors and capital-structure matters.
Sanofi has filed its annual report on Form 20-F, outlining 2025 results and a wide range of risks that could affect future performance. The company prepares its consolidated accounts under IFRS and emphasizes that forward-looking statements are highly uncertain.
Sanofi spent €7,842 million on research and development in 2025, equal to 18.0% of net sales, while its key drug Dupixent generated net sales of €15,714 million, or 36.0% of total net sales. The United States represented 50.8% of net sales, underscoring exposure to US pricing and policy changes.
The report details major risks: product liability litigation, tightening global regulation, intellectual property challenges, cyber and data-privacy threats, complex manufacturing and supply chains, climate and geopolitical disruptions, and heavy dependence on a few blockbuster products. Sanofi highlights growing pressure from US and European pricing policies, including an MFN agreement with the US government and the Inflation Reduction Act, as significant long-term headwinds.
Sanofi reported that its BTK inhibitor Wayrilz (rilzabrutinib) received FDA breakthrough therapy designation in the US and orphan drug designation in Japan for treating warm autoimmune hemolytic anemia (wAIHA), a rare autoimmune disease that destroys red blood cells and can cause serious complications.
Both designations are based on clinical data from the ongoing LUMINA 2 phase 2b study, with a new LUMINA 3 phase 3 trial comparing rilzabrutinib to placebo in wAIHA. Rilzabrutinib is already approved as Wayrilz for immune thrombocytopenia (ITP) in the US, EU, and UAE, and remains investigational for wAIHA and other rare immune-mediated diseases.
Sanofi announced a major leadership transition, with its Board deciding not to renew Paul Hudson’s Director mandate, making February 17, 2026 his last day as Chief Executive Officer. The Board has appointed Belén Garijo as the new CEO, with her term starting after the Annual General Meeting on April 29, 2026, subject to shareholder approval of her appointment as a director and an amendment to the articles of association regarding the CEO age limit. During the transition, Olivier Charmeil, Executive Vice President, General Medicines, will serve as Interim CEO. Sanofi highlights Garijo’s global pharmaceutical leadership experience and states that her priorities will include strengthening productivity, governance, and the innovation capacity of Research & Development.
Sanofi filed a Form 13F reporting its role as an institutional investment manager. The report lists 8 holdings with an aggregate market value of $310,414,825. The filing is signed by Alexandra Roger, Head of Legal Corporate & Finance, in Paris on 02-11-2026.
Sanofi has completed its acquisition of Dynavax Technologies Corporation, adding the marketed adult hepatitis B vaccine HEPLISAV‑B and a shingles vaccine candidate (Z‑1018), along with additional vaccine pipeline projects. The transaction is intended to strengthen Sanofi’s position in adult immunization by combining Dynavax’s products with Sanofi’s global commercial and development capabilities.
The tender offer for all outstanding Dynavax common shares expired on February 9, 2026, and Sanofi accepted and will pay $15.50 per share in cash, without interest and subject to applicable taxes, for all validly tendered shares and, via a follow‑on merger, for all remaining shares. Dynavax has become an indirect, wholly owned Sanofi subsidiary, and its common stock will cease trading on the NASDAQ Global Select Market as of February 10, 2026.
Sanofi filed a 6-K summarizing three developments: regulatory progress for Rezurock, pivotal data for venglustat, and a new share buyback mandate.
The European regulator’s advisory committee issued a positive opinion recommending conditional EU marketing authorization for Rezurock to treat chronic graft-versus-host disease in adults and certain adolescents after other options are exhausted. This follows a re-examination of an earlier negative view and is based on clinical and real-world data, including a phase 2 study showing a 74% overall response rate.
Sanofi also reported that venglustat met the primary and most key secondary endpoints in a phase 3 trial for type 3 Gaucher disease and plans global regulatory filings. Separately, the company signed a mandate to repurchase up to €1 billion of its own shares between February 3 and December 31, 2026.
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 reports that the European Commission has approved Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes in adults and children aged eight years and older with stage 2 disease. Teizeild is described as the first disease‑modifying therapy for type 1 diabetes approved in the EU, based on the TN‑10 phase 2 trial.
In TN‑10, the median time to diagnosis of stage 3 type 1 diabetes was 48.4 months with Teizeild versus 24.4 months with placebo, and 57% of treated patients versus 28% on placebo remained in stage 2. Frequently observed side effects included transient lymphopenia and rash. Teizeild (known as Tzield outside the EU) is already approved for the same indication in several other countries, and additional regulatory reviews are ongoing.
Sanofi reported that the US Food and Drug Administration has accepted for priority review a supplemental biologic license application for Tzield (teplizumab-mzwv). The filing seeks to expand Tzield’s current US indication from patients eight years and older to include children as young as one year with stage 2 type 1 diabetes, aiming to delay the onset of stage 3 disease. The application is backed by positive interim one-year data from the ongoing phase 4 PETITE-T1D study in children under eight. The FDA’s target action date for this review is April 29, 2026. Tzield is already approved in several countries to delay stage 3 type 1 diabetes in stage 2 patients aged eight and above.