Welcome to our dedicated page for Sanofi FR 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.
The Sanofi (SNY) SEC filings page provides access to the company’s regulatory disclosures as a foreign private issuer listed on NASDAQ and EURONEXT. Sanofi files annual reports on Form 20-F and frequent Form 6-K current reports that incorporate press releases, financial statements, and transaction documents by reference. These filings help investors track Sanofi’s operations as an R&D driven, AI-powered biopharma company focused on medicines and vaccines in immunology, autoimmune disease, rare disease, diabetes, respiratory conditions, and other areas.
Recent 6-K filings referenced in the available data include current reports attaching press releases on product approvals and recommendations (such as Wayrilz for immune thrombocytopenia, Qfitlia and Cablivi approvals in China, and high-dose influenza vaccine data), clinical and regulatory updates for pipeline assets (including tolebrutinib and efdoralprin alfa), and corporate transactions such as the completed acquisition of Vicebio and the planned acquisition of Blueprint Medicines. Other 6-Ks describe debt offerings, including the issuance and pricing of multiple series of fixed and floating rate notes under an indenture, along with the related underwriting agreement and legal opinions.
Sanofi’s interim financial information is also furnished on Form 6-K, including unaudited condensed half-year consolidated financial statements prepared under IFRS. These documents discuss topics such as discontinued operations, joint ventures, contingent consideration, royalties, and financial instruments. Together, the filings provide a detailed view of Sanofi’s capital structure, financing activities, product pipeline progress, and geographic footprint.
On this page, Stock Titan surfaces Sanofi’s latest SEC filings as they are made available from EDGAR and applies AI-powered summaries to help explain the contents of lengthy documents. Users can quickly identify key points in 20-F annual reports, 6-K current reports, and related exhibits, and can review how clinical, regulatory, and financing events are reflected in Sanofi’s official disclosures.
Sanofi reported Q1 2026 net sales of €10,509 million, up 13.6% at constant exchange rates, with business EPS rising to €1.88, an increase of 14.0% at CER. Growth was driven by pharma launches, Dupixent, and recent acquisitions.
Pharma launch sales climbed 49.6% at CER to €1.2 billion, while Dupixent sales rose 30.8% to €4.17 billion. Vaccines sales reached €1.29 billion, up 2.1% at CER, supported by newly acquired Heplisav‑B and Beyfortus. Business operating income grew 10.9% at CER to €2.97 billion, despite higher Regeneron profit sharing.
The company completed the $2.2 billion Dynavax acquisition and executed €921 million of a planned €1 billion share buyback, while net debt increased to €12.9 billion. Sanofi affirmed 2026 guidance for high single‑digit sales growth at CER, with business EPS expected to grow slightly faster than sales.
Sanofi reports two major immunology updates. Its experimental drug lunsekimig met primary and key secondary endpoints in phase 2 respiratory studies in moderate-to-severe asthma (AIRCULES) and chronic rhinosinusitis with nasal polyps (DUET), showing fewer exacerbations and better lung function or polyp scores versus placebo, with a generally acceptable safety profile. A separate phase 2b atopic dermatitis study (VELVET) missed its primary endpoint but improved key skin-clearance measures. Lunsekimig is progressing into new phase 2 and phase 3 programs in high-risk asthma.
Sanofi also announces that the European Commission approved Dupixent for moderate-to-severe chronic spontaneous urticaria in children aged two to 11 years who do not respond adequately to antihistamines and are naïve to anti-IgE therapy. This expands Dupixent’s prior EU approval in CSU for adults and adolescents, based on the LIBERTY-CUPID phase 3 program, where Dupixent reduced itch and hives and improved disease control with a safety profile consistent with earlier dermatology uses.
SANOFI reported a Schedule 13G/A showing Amundi and Amundi Asset Management beneficially own 61,506,935 shares, representing 5.04% of the class.
The filing states Amundi holds shared voting power for 30,913,607 shares and shared dispositive power for 61,506,935. It notes 27,407,379 shares are held in an employee FCPE whose voting rights are exercised by the FCPE supervisory board.
Sanofi files a Form 6-K highlighting multiple March 2026 R&D and regulatory milestones across immunology and oncology. Dupixent won approval in Japan as the first targeted medicine for adults with moderate-to-severe bullous pemphigoid, based on the LIBERTY‑BP‑ADEPT phase 2/3 study where 18% of treated patients achieved sustained disease remission versus 4% on placebo at Week 36.
The European regulator’s CHMP issued a positive opinion for a subcutaneous Sarclisa formulation delivered by on-body injector for multiple myeloma, supported by the phase 3 IRAKLIA study and other trials. Sanofi also reported positive phase 3 results for amlitelimab in three large atopic dermatitis studies (COAST 1, COAST 2 and SHORE), showing improved skin clearance and symptom relief with both every-four-week and every-12-week dosing.
Additionally, the European Commission granted conditional marketing authorisation for Rezurock to treat chronic graft-versus-host disease in patients aged 12 and older when prior systemic therapies are inadequate. This decision drew on phase 2 ROCKstar data, where Rezurock delivered a 74% best overall response rate, and supports Sanofi’s expansion in serious immune-mediated diseases.
Sanofi reports that the US FDA has granted Breakthrough Therapy designation to venglustat, an investigational oral glucosylceramide synthase inhibitor, for treating neurological manifestations of type 3 Gaucher disease, a rare lysosomal storage disorder.
The designation is based on the phase 3 LEAP2MONO study, where patients on venglustat showed statistically significant neurological improvement versus those on imiglucerase enzyme replacement therapy (p=0.007). Venglustat was generally well tolerated; the most common adverse events included headache, nausea, spleen enlargement and diarrhea, with comparable or acceptable rates versus the comparator arm.
There are currently no approved treatments for the neurological symptoms of GD3, and venglustat is designed to cross the blood-brain barrier to address underlying central nervous system pathology. Sanofi plans to pursue global regulatory filings for venglustat in GD3 during 2026.
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.