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 report summarizing two regulatory milestones from September 2025. The company notes a press release on a positive CHMP opinion in the European Union for Dupixent, developed with Regeneron, for treating chronic spontaneous urticaria. A second press release covers an update on the U.S. regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis. The report itself mainly serves to formally furnish these press releases to investors.
Sanofi filed a Form 6-K to share a press release about its experimental medicine amlitelimab. The release states that amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic dermatitis. This means the treatment achieved the main goals and important additional measures set for this late-stage clinical trial, suggesting a broadly positive result for this patient group.
Sanofi (SNY) filed a Form 6-K that includes an exhibit: a press release dated August 29, 2025 announcing that Wayrilz was approved in the United States as the first BTK inhibitor indicated for immune thrombocytopenia. The filing itself is dated September 3, 2025 and is signed by Alexandra Roger, Head of Legal Corporate & Finance.
The disclosure is concise: it notifies investors that a regulatory approval milestone was achieved for a new therapeutic option in immune thrombocytopenia and that the company has publicly released that information via a press release attached as Exhibit 99.1.
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.