Sanofi reports phase 2 success for AlphaMedix in GEP-NETs

Rhea-AI Filing Summary

Sanofi furnished a Form 6-K announcing a press release dated October 8, 2025. The release states that AlphaMedixTM (212Pb-DOTAMTATE) achieved all primary efficacy endpoints in a phase 2 study, demonstrating clinically meaningful benefits in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This update highlights mid-stage clinical results disclosed via an attached exhibit.

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 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 8, 2025: AlphaMedixTM (212Pb-DOTAMTATE) achieved all primary efficacy endpoints in phase  2 study, demonstrating clinically meaningful benefits in patients with gastroenteropancreatic neuroendocrine tumors

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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 15, 2025				SANOFI
				By		/s/ Alexandra Roger
						Name: Alexandra Roger
						Title: Head of Legal Corporate & Finance

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FAQ

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

Sanofi furnished a press release stating AlphaMedixTM (212Pb-DOTAMTATE) met all primary efficacy endpoints in a phase 2 study for GEP-NETs.

What is AlphaMedixTM (212Pb-DOTAMTATE)?

It is Sanofi’s radioligand therapy candidate referenced in the press release attached to the 6-K.

What clinical stage is AlphaMedixTM in according to the filing?

Phase 2, with all primary efficacy endpoints achieved per the exhibit description.

Which patients were studied?

Patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

When was the press release issued?

October 8, 2025, and it was furnished as Exhibit 99.1 to the 6-K.

Does the filing include detailed efficacy data or safety results?

The excerpt references the outcome but does not provide detailed data within the text provided.