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 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 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.
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.
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.