Sanofi files 6-K with CHMP, FDA and vaccine data updates

Rhea-AI Filing Summary

Sanofi furnished a Form 6-K listing recent company press releases from October 17–20, 2025. The exhibits cover: an EU regulatory review update for Rezurock in chronic graft-vs-host disease; a CHMP recommendation for EU approval of Wayrilz to treat immune thrombocytopenia; new data showing Sanofi’s high-dose influenza vaccine provided superior protection for older adults against hospitalization versus standard-dose; ESMO phase 2 findings for AlphaMedix supporting first-in-class potential in gastroenteropancreatic neuroendocrine tumors; and Tzield being accepted for expedited review in the US through the FDA Commissioner’s National Priority Voucher pilot program.

The filing compiles these updates for investors and incorporates the press releases by reference.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of October 2025

Commission File Number: 001-31368

SANOFI

(Translation of registrant’s name into English)

46, avenue de la Grande Armée, 75017 Paris, FRANCE

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒  Form 40-F ☐

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In October 2025, Sanofi published the press releases attached hereto as Exhibits 99.1, 99.2, 99.3, 99.4 and 99.5 which are incorporated herein by reference.

Exhibit Index

Exhibit No.		Description
Exhibit 99.1		Press Release dated October  17, 2025: Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic graft-vs-host disease
Exhibit 99.2		Press Release dated October 17, 2025: Sanofi’s Wayrilz recommended for EU approval by the CHMP to treat immune thrombocytopenia
Exhibit 99.3		Press Release dated October 20, 2025: Sanofi’s high-dose influenza vaccine demonstrates superior protection for older adults against hospitalization vs standard-dose
Exhibit 99.4		Press Release dated October  20, 2025: ESMO: AlphaMedixTM phase 2 data support first-in-class potential of new targeted alpha therapy in gastroenteropancreatic neuroendocrine tumors
Exhibit 99.5		Press Release dated October  20, 2025: Sanofi’s Tzield accepted for expedited review in the US for stage 3 type 1 diabetes through FDA Commissioner’s National Priority Voucher pilot program

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Dated: October 24, 2025				SANOFI
		By		/s/ Alexandra Roger
				Name: Alexandra Roger Title: Head of Legal Corporate & Finance

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FAQ

What did Sanofi (SNY) file in this Form 6-K?

Sanofi furnished a 6-K that incorporates by reference press releases published on October 17 and 20, 2025.

Which products are mentioned in Sanofi’s October 2025 updates?

Rezurock, Wayrilz, Sanofi’s high-dose influenza vaccine, AlphaMedix, and Tzield.

Did the CHMP take action related to Sanofi in October 2025?

Yes. The CHMP recommended EU approval for Wayrilz to treat immune thrombocytopenia.

What does the 6-K say about Tzield in the US?

Tzield was accepted for expedited review through the FDA Commissioner’s National Priority Voucher pilot program.

What influenza vaccine data did Sanofi reference?

A press release reported superior protection for older adults against hospitalization versus standard-dose vaccine.

What oncology data were included in the exhibits?

Phase 2 data for AlphaMedix presented at ESMO supporting first-in-class potential in GEP neuroendocrine tumors.

Is there an EU update for Rezurock?

Yes. Sanofi provided an update on the regulatory review in the EU for Rezurock to treat chronic graft-vs-host disease.