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

Rhea-AI Filing Summary

Sanofi reported two corporate developments in an exhibit list attached to its Form 6-K. A press release dated September 23, 2025, states that Sanofi's investigational medicine SAR446268 received U.S. Fast Track designation for the treatment of non-congenital myotonic dystrophy type 1, signaling accelerated regulatory review for that indication. A separate press release dated September 24, 2025, states Sanofi is committing an additional $625 million to Sanofi Ventures to boost investments in biotech and digital health innovation.

Both items are presented as exhibits to the current report and indicate near-term regulatory and strategic investment activity explicitly disclosed by the company.

Positive

• SAR446268 received U.S. Fast Track designation for non-congenital myotonic dystrophy type 1
• Sanofi committed an additional $625 million to Sanofi Ventures to expand biotech and digital health investments

Negative

• None.

Insights

Biotech R&D Strategist

Fast Track designation may accelerate SAR446268's U.S. review timeline.

The document explicitly states SAR446268 received U.S. Fast Track designation for non-congenital myotonic dystrophy type 1, which is a regulatory pathway designed to expedite development and review of therapies for serious conditions. This status can enable more frequent interactions with FDA and potential rolling submissions, possibly shortening time to approval if subsequent data are supportive.

Corporate Finance Analyst

$625M increase to Sanofi Ventures signals larger strategic deployment of capital into innovation.

The filing explicitly discloses an additional committed amount of $625 million to Sanofi Ventures to accelerate investments in biotech and digital health. That is a quantifiable, strategic capital allocation that may expand Sanofi's external innovation pipeline and influence future dealflow or minority investments, as stated in the exhibits.

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  23, 2025: Sanofi’s SAR446268 earns US fast track designation for the treatment of non-congenital myotonic dystrophy type 1
Exhibit 99.2		Press Release dated September 24, 2025: Sanofi commits an additional $625 million to Sanofi Ventures to accelerate investment in biotech and digital health innovation

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 26, 2025				SANOFI
				By		/s/ Alexandra Roger
						Name: Alexandra Roger
						Title: Head of Legal Corporate & Finance

3

FAQ

What did Sanofi disclose in the Form 6-K regarding SAR446268 (SNY)?

The Form 6-K exhibits include a press release dated September 23, 2025 stating SAR446268 earned U.S. Fast Track designation for non-congenital myotonic dystrophy type 1.

How much additional funding did Sanofi commit to Sanofi Ventures?

The filing discloses an additional $625 million committed to Sanofi Ventures to accelerate investments in biotech and digital health, per the September 24, 2025 press release.

Do the exhibits indicate regulatory approval for SAR446268?

No. The exhibit states SAR446268 received Fast Track designation, which expedites development and review but is not an approval.

Are specific investments or targets named for the $625 million commitment?

The exhibit text provided in the filing only states the $625 million commitment to accelerate investment in biotech and digital health; it does not list specific target companies or funds.

Where can investors find the full press releases referenced in the 6-K?

The Form 6-K lists the press releases as Exhibits 99.1 (Sept 23, 2025) and 99.2 (Sept 24, 2025), which should contain the full disclosures.