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.
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 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.
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 filed a Form 6-K to furnish two December 15, 2025 press releases related to its multiple sclerosis candidate tolebrutinib. One press release provides an update on the regulatory submission for tolebrutinib in non-relapsing secondary progressive multiple sclerosis, and the other provides an update on tolebrutinib in primary progressive multiple sclerosis. Both press releases are incorporated into this report by reference.
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 filed a Form 13F reporting its institutional holdings. The filing lists 9 holdings entries with a total reported market value of $260,361,143 (rounded to nearest dollar). The report is signed by Alexandra Roger, Head of Legal Corporate & Finance, and dated 11-04-2025.
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.
Sanofi furnished a Form 6-K noting a press release titled “Sanofi successfully prices USD 3 billion of bond issue.” The filing indicates the company priced a USD 3 billion bond and includes the press release as Exhibit 99.1.
The press release is dated October 28, 2025, and is incorporated by reference in the submission.