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 filed a Form 6-K summarizing three March 2026 updates. Japan’s Ministry of Health, Labour and Welfare granted orphan drug designation to rilzabrutinib, an oral BTK inhibitor, for IgG4-related disease after phase 2 data showed reduced disease flares, improved markers and lower glucocorticoid use, with a safety profile consistent with earlier studies. Rilzabrutinib is approved for immune thrombocytopenia in the US, EU and UAE and is in a phase 3 IgG4-RD study. Sanofi also filed an amendment to its French “Document d’Enregistrement Universel” containing the Annual Financial Report, adding corporate governance information. The Board will ask shareholders on April 29, 2026 to appoint Christel Heydemann as an independent director, renew the mandates of Christophe Babule and Jean‑Paul Kress, and notes that Patrick Kron will leave the Board, which would remain at 16 members and 57% women excluding employee representatives.
Sanofi reports governance and compensation changes around its CEO transition. Former Chief Executive Officer Paul Hudson’s mandate ended on February 17, 2026; he resigned as director on February 18 and will receive pro rata 2026 salary and bonus plus a gross termination benefit of €5,207,750 and a €3,124,650 nine‑month non‑compete indemnity, alongside vested and potential performance shares subject to conditions.
Interim CEO Olivier Charmeil keeps his existing executive contract and receives only top‑up cash compensation, with no equity or in‑kind benefits. The future CEO, Belén Garijo, will have fixed pay of €1,600,000 and variable pay targeted at 150% of salary, plus performance share awards totaling 360,000 shares over her four‑year term, split between a 180,000‑share long‑term tranche heavily tied to relative TSR and annual medium‑term tranches. Her package includes a four‑year relocation benefit, a tighter 12‑month cap on termination benefits, a 12‑month non‑compete indemnity, no top‑up pension, strict performance and service conditions on equity, and a clawback policy for erroneously calculated variable pay.
Sanofi reports multiple regulatory milestones centered on its Dupixent franchise and a new treatment for sleeping sickness. The FDA approved Dupixent for allergic fungal rhinosinusitis in patients aged six and older with prior sino-nasal surgery, after a phase 3 trial showed a 50% sinus opacification improvement versus 10% on placebo and a 92% reduction in need for repeat surgery or systemic steroids.
Separately, the EU’s CHMP issued a positive opinion on Acoziborole Winthrop, a three-tablet, single-dose oral treatment for gambiense sleeping sickness, supported by a phase 2/3 study with up to a 96% success rate at 18 months. Sanofi plans to donate the drug to the WHO for free patient access. The CHMP also recommended EU approval of Dupixent for chronic spontaneous urticaria in children aged two to 11, while a U.S. FDA decision on a related pediatric indication is expected by April 2026.
Sanofi furnished a report highlighting new clinical data and regulatory filings. A real-world study of Beyfortus (nirsevimab) in Galicia, Spain found a 94.4% coverage rate (11,796 of 12,492 infants) and an 85.9% reduction in RSV-related lower respiratory tract infection hospitalizations during the first season. Among infants immunized in their first season, hospitalizations fell 55.3% in the second RSV season, with substantial decreases in RSV-related rehospitalizations as well.
Sanofi and Teva reported phase 2b long-term extension results for duvakitug in ulcerative colitis and Crohn’s disease, showing durable clinical and endoscopic efficacy over 44 weeks in patients who initially responded to induction therapy, with both 450 mg and 900 mg doses well tolerated. Sanofi also announced it has filed its 2025 Form 20-F with the SEC and its French “Document d’Enregistrement Universel” containing the Annual Financial Report with the AMF.
Amundi and Amundi Asset Management filed an amended Schedule 13G reporting beneficial ownership of 62,741,607 Sanofi common shares and ADRs, representing 5.11% of the class. They report no sole voting or dispositive power, with 31,006,825 shares subject to shared voting power and 62,741,607 shares subject to shared dispositive power.
The filing explains that 27,972,813 of these shares are held through a French employee investment vehicle (FCPE) dedicated to Sanofi employees, where voting rights are exercised by the FCPE supervisory board rather than Amundi. Amundi certifies that the securities were acquired and are held in the ordinary course of business and not for the purpose of changing or influencing control of Sanofi.
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.