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 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.
Sanofi, through Samba Merger Sub, has successfully completed its cash tender offer for Dynavax Technologies at $15.50 per share. The purchaser has irrevocably accepted for payment all Dynavax shares validly tendered and not withdrawn under the offer.
Because the Sanofi group now holds more than the percentage of shares needed to approve the merger agreement, it plans to complete a merger under Section 251(h) of Delaware law without a Dynavax stockholder vote. At the merger’s effective time, each remaining Dynavax share (with limited exceptions such as treasury shares and properly perfected appraisal shares) will be converted into the right to receive the same $15.50 cash merger consideration. After the merger, Dynavax shares will be delisted from the NASDAQ Global Select Market and deregistered under the Exchange Act, ending public trading in the stock.
Sanofi filed a 6-K summarizing three developments: regulatory progress for Rezurock, pivotal data for venglustat, and a new share buyback mandate.
The European regulator’s advisory committee issued a positive opinion recommending conditional EU marketing authorization for Rezurock to treat chronic graft-versus-host disease in adults and certain adolescents after other options are exhausted. This follows a re-examination of an earlier negative view and is based on clinical and real-world data, including a phase 2 study showing a 74% overall response rate.
Sanofi also reported that venglustat met the primary and most key secondary endpoints in a phase 3 trial for type 3 Gaucher disease and plans global regulatory filings. Separately, the company signed a mandate to repurchase up to €1 billion of its own shares between February 3 and December 31, 2026.
Sanofi, through Samba Merger Sub, is pursuing a cash tender offer to acquire all outstanding shares of Dynavax Technologies for $15.50 per share. This amendment reports that Germany’s Federal Ministry for Economic Affairs and Energy cleared the related Dynavax GmbH foreign investment transaction effective January 29, 2026.
The German foreign direct investment clearance had been a condition to acquiring 100% of the voting rights in Dynavax GmbH, a Dynavax subsidiary. With this regulatory approval in place, a key international review hurdle tied to the tender offer structure has been satisfied.
Sanofi reported strong 2025 growth with a rich pipeline and active capital return. Net sales reached €43,626 million, up 9.9% at constant exchange rates, led by Dupixent (€15,714 million, +25.2%) and new pharma launches (€3,911 million, +47.9%). Business EPS rose to €7.83, up 15.0% at constant exchange rates, while free cash flow was €8,089 million.
In Q4 2025, sales were €11,303 million (+13.3% at constant exchange rates) and business EPS was €1.53 (+26.7% at constant exchange rates), showing margin expansion from a shift toward specialty medicines. IFRS EPS was -€0.66 in the quarter, mainly reflecting large intangible impairments including tolebrutinib.
Sanofi completed a €5 billion share buyback and proposes a €4.12 dividend for 2025, its 31st consecutive increase, and plans a €1 billion buyback in 2026. It closed the $1.2 billion Vicebio acquisition, agreed to acquire Dynavax for about $2.2 billion, and generated €10.4 billion net cash from the Opella consumer health separation. For 2026, Sanofi expects sales to grow by a high single-digit percentage at constant exchange rates with business EPS growing slightly faster, and sees profitable growth continuing for at least five years.
Samba Merger Sub, an indirect Sanofi subsidiary, has amended its cash tender offer for all Dynavax Technologies shares at $15.50 per share. The update confirms key regulatory clearances and outlines shareholder litigation related to the deal.
The 15-day waiting period under the U.S. Hart-Scott-Rodino Act expired effective January 27, 2026, satisfying the offer condition tied to U.S. antitrust review. German merger control clearance was also received from the Federal Cartel Office on January 14, 2026, allowing the acquisition to proceed under German competition law.
As of January 28, 2026, one federal and two New York state court complaints, plus multiple stockholder demand letters and a books and records demand, challenge aspects of the transaction disclosures and seek to delay or unwind the deal. Dynavax and its directors state they intend to vigorously defend these actions.
Sanofi reported new late-stage clinical results for amlitelimab, an experimental antibody targeting OX40-ligand for patients 12 and older with moderate-to-severe atopic dermatitis.
Two global phase 3 trials, SHORE and COAST 2, showed that amlitelimab given every four or twelve weeks improved skin clearance and disease severity at Week 24 versus placebo on key measures such as vIGA-AD 0/1 and EASI-75, with a safety profile similar to placebo in both studies. In COAST 2, amlitelimab met the primary endpoint for the US estimand but did not achieve statistical significance on co-primary endpoints for the EU estimand.
A preliminary analysis of the open-label ATLANTIS phase 2 study showed progressive improvement in vIGA-AD 0/1 from 35.4% at Week 24 to 50.3% at Week 52 and EASI-75 from 62.9% to 76.5%, with low discontinuations and serious adverse events. Sanofi plans global regulatory submissions for amlitelimab in the second half of 2026, while emphasizing that the drug remains under clinical development and is not yet approved.
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 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.