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 filed a Form 6-K reporting an attached press release dated August 14, 2025, announcing that its investigational drug rilzabrutinib received orphan designation in the European Union for the treatment of IgG4-related disease. The filing includes the company signature block signed by Alexandra Roger, Head of Legal Corporate & Finance, dated August 29, 2025. The document is a brief disclosure of the press release and does not contain financial results, transaction details, or additional corporate commentary.
Amundi and Amundi Asset Management report beneficial ownership of 61,769,803 shares of Sanofi (common stock and ADRs), representing 5.03% of the class. The filing shows no sole voting or dispositive power and records shared voting power of 29,534,426 shares and shared dispositive power of 61,769,803 shares.
The filing discloses that 26,790,332 shares are held through an employee FCPE on which Amundi does not exercise voting rights; those voting rights are exercised by the FCPE supervisory board where employee representatives hold the majority. The reporting persons are organized in France and filed this Schedule 13G/A under the Securities Exchange Act.
Sanofi (SNY) has filed a July 2025 Form 6-K that incorporates two press releases.
- 16 Jul 2025: Investigational complement inhibitor SAR446597 received FDA Fast Track designation for geographic atrophy secondary to age-related macular degeneration, potentially accelerating development and review.
- 22 Jul 2025: Sanofi announced an agreement to acquire Vicebio, a private company developing respiratory vaccines, to broaden its vaccines pipeline.
No financial statements, deal value, or timing details are included in the filing. Nonetheless, the regulatory milestone and pipeline-expanding acquisition underscore Sanofi’s strategic emphasis on specialty therapies and vaccines, areas that management views as key long-term growth drivers.
Sanofi (SNY) filed a Form 6-K to notify investors that its investigational monoclonal antibody riliprubart has received orphan-drug designation in two major markets during June 2025:
- United States (FDA) – for the prevention of antibody-mediated rejection in solid-organ transplantation (Press Release 25 Jun 2025).
- Japan (MHLW) – for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) (Press Release 30 Jun 2025).
Orphan-drug status can confer regulatory incentives such as market exclusivity (7 years in the U.S., up to 10 years in Japan), tax credits, fee waivers and a potentially faster approval pathway. Although the filing does not disclose clinical data, financial terms or timelines, the dual designation signals regulatory validation of riliprubart’s potential across two distinct immunological indications. No other material transactions, financial results or strategic changes are included in this 6-K.
Sanofi has reported three significant developments in their drug portfolio through Form 6-K filed on June 28, 2025:
- Dupixent superiority demonstrated over Xolair (omalizumab) in the first-ever phase 4 head-to-head respiratory study for treating chronic rhinosinusitis with nasal polyps in patients with coexisting asthma (June 15, 2025)
- FDA approval secured for Dupixent as the only targeted medicine for treating bullous pemphigoid, expanding its therapeutic applications (June 20, 2025)
- CHMP recommendation received for Sarclisa's EU approval to treat transplant-eligible newly diagnosed multiple myeloma (June 23, 2025)
These developments represent significant regulatory and clinical milestones for Sanofi's key drug products, particularly strengthening Dupixent's market position across multiple indications and advancing Sarclisa's potential availability in the EU market for multiple myeloma treatment.
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