SNY July 2025 Filing Highlights FDA Fast Track Win & Vicebio Acquisition

Rhea-AI Filing Summary

Sanofi (SNY) has filed a July 2025 Form 6-K that incorporates two press releases.

• 16 Jul 2025: Investigational complement inhibitor SAR446597 received FDA Fast Track designation for geographic atrophy secondary to age-related macular degeneration, potentially accelerating development and review.
• 22 Jul 2025: Sanofi announced an agreement to acquire Vicebio, a private company developing respiratory vaccines, to broaden its vaccines pipeline.

No financial statements, deal value, or timing details are included in the filing. Nonetheless, the regulatory milestone and pipeline-expanding acquisition underscore Sanofi’s strategic emphasis on specialty therapies and vaccines, areas that management views as key long-term growth drivers.

Positive

• FDA Fast Track designation for SAR446597 may shorten development timelines and de-risk regulatory approval.
• Acquisition of Vicebio expands Sanofi’s respiratory vaccine pipeline, aligning with strategic growth areas.

Negative

• Filing provides no financial terms or timelines for the Vicebio acquisition, limiting assessment of economic impact.

Insights

Equity Research Analyst

TL;DR – Positive pipeline catalysts: fast-track drug & vaccine acquisition; financial terms absent.

The fast-track designation enhances the probability of earlier U.S. market entry for SAR446597 and signals FDA recognition of unmet need in geographic atrophy. The Vicebio purchase, although undisclosed in value, strengthens Sanofi’s respiratory vaccine franchise ahead of anticipated market expansion. While the lack of financial metrics limits immediate valuation impact, both events are strategically accretive to the R&D narrative and could support medium-term revenue growth if clinical results remain favorable. Overall impact is positive and material for long-term investors.

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 July 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 July 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 July  16, 2025: Sanofi’s SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration
Exhibit 99.2		Press Release dated July 22, 2025: Sanofi to acquire Vicebio, expanding respiratory vaccines pipeline

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

3

FAQ

What did Sanofi (SNY) announce in its July 2025 Form 6-K?

The filing incorporates press releases on FDA Fast Track status for SAR446597 and the planned acquisition of respiratory-vaccine developer Vicebio.

Why is FDA Fast Track designation for SAR446597 important?

Fast Track can enable rolling submissions and accelerated review, potentially bringing the geographic atrophy therapy to market sooner.

What is Vicebio and why is Sanofi acquiring it?

Vicebio is a private company focused on respiratory vaccines. Sanofi aims to broaden its vaccine portfolio through the acquisition.

Did Sanofi disclose the purchase price for Vicebio?

No. The Form 6-K and referenced press release do not state the deal value or financial terms.

Does the 6-K include any earnings or financial statements?

No. The document only references the two press releases and contains no financial data.