Sanofi (SNYNF) highlights EU Dupixent opinion and US tolebrutinib review

Rhea-AI Filing Summary

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.

Insights

Biopharma regulatory analyst

Sanofi highlights EU and US regulatory steps for key drugs.

Sanofi is drawing attention to two late-stage regulatory developments. One relates to a positive CHMP opinion in the EU for Dupixent in chronic spontaneous urticaria, which is a step in the European approval process. The other is an update on the U.S. review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis.

The filing itself gives only high-level descriptions and points to separate press releases for details, without disclosing financial figures or timelines. The importance of these items will depend on final regulatory decisions and eventual prescribing patterns, which are not addressed here.

Subsequent company communications and future periodic reports would be the main places to find any quantified impact if these regulatory processes move forward.

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 September 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 ☐

1

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

Exhibit Index

Exhibit No.		Description
Exhibit 99.1		Press Release dated September 22, 2025: Sanofi and Regeneron’s Dupixent to treat chronic spontaneous urticaria advances in EU with positive CHMP opinion
Exhibit 99.2		Press Release dated September 22, 2025: Update on the US regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis

2

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: September 22, 2025						SANOFI
				By		/s/ Alexandra Roger
						Name: Alexandra Roger
						Title: Head of Legal Corporate & Finance

3

FAQ

What does Sanofi (SNYNF) report in its September 2025 6-K?

The 6-K states that in September 2025 Sanofi issued two press releases, one on a positive CHMP opinion in the EU for Dupixent in chronic spontaneous urticaria and another on an update to the U.S. regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis.

What is the significance of the positive CHMP opinion for Sanofi (SNYNF) and Dupixent?

Sanofi reports that Dupixent, developed with Regeneron, received a positive CHMP opinion in the European Union for treating chronic spontaneous urticaria, which is an important step in the EU regulatory pathway for this indication.

Which indications are mentioned for Sanofi’s tolebrutinib in this 6-K?

The filing references a press release on the U.S. regulatory review of tolebrutinib for non-relapsing, secondary progressive multiple sclerosis.

Does the Sanofi (SNYNF) 6-K provide financial figures or sales projections?

No, this 6-K only notes that Sanofi issued two regulatory-focused press releases and incorporates them by reference; it does not include financial metrics or sales projections.

Are the full Sanofi (SNYNF) press releases included in the 6-K?

The 6-K identifies the press releases as Exhibits 99.1 and 99.2 and incorporates them by reference, indicating they accompany the report as attached exhibits.

Who signed the September 2025 Sanofi (SNYNF) 6-K filing?

The report is signed on behalf of Sanofi by Alexandra Roger, who is identified as Head of Legal Corporate & Finance.