SNY: Rilzabrutinib Granted EU Orphan Status for IgG4-Related Disease

Rhea-AI Filing Summary

Sanofi filed a Form 6-K reporting an attached press release dated August 14, 2025, announcing that its investigational drug rilzabrutinib received orphan designation in the European Union for the treatment of IgG4-related disease. The filing includes the company signature block signed by Alexandra Roger, Head of Legal Corporate & Finance, dated August 29, 2025. The document is a brief disclosure of the press release and does not contain financial results, transaction details, or additional corporate commentary.

Positive

• Rilzabrutinib received orphan designation in the EU for IgG4-related disease, as stated in the attached press release dated August 14, 2025
• Form 6-K properly discloses the press release and includes an authorized company signature from Alexandra Roger

Negative

• None.

Insights

Regulatory Affairs Specialist

TL;DR: Orphan designation in the EU for rilzabrutinib is a regulatory milestone that can provide development incentives and market exclusivity benefits.

The filing itself is a short Form 6-K that attaches a press release stating rilzabrutinib earned orphan designation in the European Union for IgG4-related disease. From a regulatory perspective, orphan designation typically grants benefits such as protocol assistance, potential fee reductions, and a period of market exclusivity once approved. The document contains no further details on clinical data, timelines, or commercial strategy, so the precise commercial or timeline impact cannot be assessed from this filing alone.

Securities/Investor Relations Analyst

TL;DR: The 6-K is a routine disclosure of a press release; materiality depends on the program's stage and commercial potential, not provided here.

Sanofi's submission notifies investors that a regulatory designation was granted to rilzabrutinib for IgG4-related disease in the EU. The filing includes the press release date and corporate signature but provides no financial metrics, development stage details, or guidance. As such, while the designation is noteworthy, the filing lacks the additional context investors need to evaluate revenue or timeline implications.

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 August 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 August 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 August 14, 2025: Sanofi’s rilzabrutinib earns orphan designation in the EU for IgG4-related disease.

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: August 29, 2025				SANOFI
				By		/s/ Alexandra Roger
						Name: Alexandra Roger
						Title: Head of Legal Corporate & Finance

3

FAQ

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

The 6-K attaches a press release dated August 14, 2025 stating that rilzabrutinib earned orphan designation in the EU for IgG4-related disease; the filing is signed by Alexandra Roger.

When was the attached press release dated in the filing?

The press release attached to the Form 6-K is dated August 14, 2025.

Who signed the Form 6-K for Sanofi?

The document is signed by Alexandra Roger, listed as Head of Legal Corporate & Finance, and dated August 29, 2025.

Does the 6-K include financial results or development timelines for rilzabrutinib?

No. The filing only references the press release announcing EU orphan designation and contains no financial data, timelines, or clinical details.

What is the regulatory action described in the filing?

The filing reports that rilzabrutinib has been granted orphan designation in the European Union for IgG4-related disease, as per the attached press release.