[6-K] Sanofi Current Report (Foreign Issuer)

Rhea-AI Filing Summary

Sanofi (SNY) furnished a Form 6-K noting it has attached a press release dated October 22, 2025. The release reports that efdoralprin alfa met all primary and key secondary endpoints in a phase 2 study for alpha-1 antitrypsin deficiency (AATD) emphysema. This update signals a positive clinical milestone for the program and supports continued development based on the study’s predefined goals.

The filing itself provides no additional trial data beyond the headline result. Readers seeking design details, specific endpoints, or safety and efficacy metrics should refer to Exhibit 99.1, which contains the full press release.

Insights

Biopharma clinical development analyst

Phase 2 success headline; details in attached press release.

Sanofi reports that efdoralprin alfa met all primary and key secondary endpoints in a phase 2 AATD emphysema study. Hitting both primary and key secondary endpoints typically indicates the trial met its predefined goals, a necessary step before advancing development.

The excerpt does not include study size, endpoint definitions, or safety outcomes, which are critical for assessing clinical relevance and next steps. Subsequent filings may provide the quantitative results and proposed development plans.

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 ☐

1

In October 2025, Sanofi published the press release attached hereto as Exhibit 99.1 which is incorporated herein by reference.

Exhibit Index

Exhibit No.		Description
Exhibit 99.1		Press Release dated October  22, 2025: Sanofi’s efdoralprin alfa met all primary and key secondary endpoints in alpha-1 antitrypsin deficiency emphysema phase 2 study

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: October 31, 2025						SANOFI
				By		/s/ Alexandra Roger
						Name: Alexandra Roger
						Title: Head of Legal Corporate & Finance

3

FAQ

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

Sanofi furnished a press release (Exhibit 99.1) stating that efdoralprin alfa met all primary and key secondary endpoints in a phase 2 AATD emphysema study.

Which program is highlighted in Sanofi’s update?

Efdoralprin alfa, studied for alpha-1 antitrypsin deficiency emphysema.

What stage of development is efdoralprin alfa in?

Phase 2, according to the attached press release headline.

What were the reported study outcomes?

The study met all primary and key secondary endpoints, per the press release headline.

When was the press release issued?

October 22, 2025, as listed for Exhibit 99.1.

Where can I find more details on the trial results?

See Exhibit 99.1 to the Form 6-K, which contains the full press release.