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 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 request seeks to expand the current indication from patients aged eight years and older to include children as young as one year old diagnosed with stage 2 type 1 diabetes, to delay the onset of stage 3 disease.
The application is supported by positive interim one-year data from the ongoing PETITE-T1D phase 4 study, which has enrolled 23 young participants and evaluates the safety and pharmacokinetics of Tzield given as a 14-day intravenous infusion regimen. The FDA’s target action date for this review is April 29, 2026. Tzield is already approved in multiple countries for delaying stage 3 type 1 diabetes in adults and children eight years and older, but its use in the PETITE-T1D population has not been approved by any regulatory authority.
Sanofi reported that its medicine Wayrilz has been approved in the European Union as the first BTK inhibitor to treat immune thrombocytopenia, a rare disorder involving low platelet counts. This marks a new treatment option in the EU using Bruton’s tyrosine kinase (BTK) inhibition specifically for this disease. The update is provided through a Form 6-K that forwards a December 23, 2025 press release about the approval.
Sanofi reports two key developments from December 2025. The company completed its acquisition of Vicebio, as described in a press release dated December 4, 2025.
A second press release dated December 11, 2025 reports that Sanofi’s medicines Qfitlia and Cablivi were approved in China, expanding care options for patients with rare diseases in that market.
Sanofi furnished a report summarizing two recent regulatory milestones. One press release describes a pivotal study of Dupixent in allergic fungal rhinosinusitis that met all primary and secondary endpoints and reduced signs and symptoms of the disease, and notes that a supplemental Biologics License Application has been accepted for FDA priority review. A second press release states that Teizeild has been recommended for European Union approval by the CHMP for patients with stage 2 type 1 diabetes.
Sanofi reported the issuance of multiple U.S. dollar notes on November 3, 2025, totaling $3,000,000,000 in principal. The company sold $500,000,000 floating rate notes due November 3, 2027, $500,000,000 floating rate notes due November 3, 2028, $400,000,000 fixed rate notes due November 3, 2027, $400,000,000 fixed rate notes due November 3, 2028, and $1,200,000,000 fixed rate notes due November 3, 2032.
The report is incorporated by reference into Sanofi’s Form F-3 (No. 333-278506). Exhibits include the underwriting agreement with Barclays Capital Inc., BNP Paribas Securities Corp., BofA Securities, Inc., J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, MUFG Securities Americas Inc., and Natixis Securities Americas LLC; an indenture with Deutsche Bank Trust Company Americas as trustee; form notes for each tranche; and legal opinions from Jones Day under French and New York law.
Sanofi (SNY) furnished a Form 6-K noting it has attached a press release dated October 22, 2025. The release reports that efdoralprin alfa met all primary and key secondary endpoints in a phase 2 study for alpha-1 antitrypsin deficiency (AATD) emphysema. This update signals a positive clinical milestone for the program and supports continued development based on the study’s predefined goals.
The filing itself provides no additional trial data beyond the headline result. Readers seeking design details, specific endpoints, or safety and efficacy metrics should refer to Exhibit 99.1, which contains the full press release.
Sanofi S.A. launched a primary debt offering of $500,000,000 floating rate notes due 2027, $500,000,000 floating rate notes due 2028, $400,000,000 3.750% notes due 2027, $400,000,000 3.800% notes due 2028, and $1,200,000,000 4.200% notes due 2032. Interest begins accruing on November 3, 2025.
The floating notes pay Compounded SOFR plus 0.460% (2027) or 0.540% (2028) with quarterly payments; fixed notes pay semiannually. Fixed tranches feature make‑whole redemption prior to defined par call dates, and par redemption thereafter; floaters are not redeemable before maturity except for tax events. The notes are unsecured, unsubordinated, not listed, and issued in $2,000 minimums.
Gross pricing reflected modest underwriting discounts, and net proceeds are approximately $2,986,198,000, intended for general corporate purposes.