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 announced a major leadership transition, with its Board deciding not to renew Paul Hudson’s Director mandate, making February 17, 2026 his last day as Chief Executive Officer. The Board has appointed Belén Garijo as the new CEO, with her term starting after the Annual General Meeting on April 29, 2026, subject to shareholder approval of her appointment as a director and an amendment to the articles of association regarding the CEO age limit. During the transition, Olivier Charmeil, Executive Vice President, General Medicines, will serve as Interim CEO. Sanofi highlights Garijo’s global pharmaceutical leadership experience and states that her priorities will include strengthening productivity, governance, and the innovation capacity of Research & Development.
Sanofi filed a Form 13F reporting its role as an institutional investment manager. The report lists 8 holdings with an aggregate market value of $310,414,825. The filing is signed by Alexandra Roger, Head of Legal Corporate & Finance, in Paris on 02-11-2026.
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, 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.