Sanofi (SNY) gets EU nod for Wayrilz, first BTK inhibitor for ITP

Rhea-AI Filing Summary

Sanofi reported that its medicine Wayrilz has been approved in the European Union as the first BTK inhibitor to treat immune thrombocytopenia, a rare disorder involving low platelet counts. This marks a new treatment option in the EU using Bruton’s tyrosine kinase (BTK) inhibition specifically for this disease. The update is provided through a Form 6-K that forwards a December 23, 2025 press release about the approval.

Positive

• EU approval of Wayrilz as the first BTK inhibitor to treat immune thrombocytopenia, expanding Sanofi’s hematology portfolio with a differentiated mechanism in a rare blood disorder.

Negative

• None.

Insights

Biopharma regulatory specialist

EU approval of Wayrilz for immune thrombocytopenia is a potentially meaningful product milestone for Sanofi.

The disclosure centers on Wayrilz receiving approval in the European Union as the first BTK inhibitor to treat immune thrombocytopenia. Gaining an EU authorization for a novel mechanism in a defined rare blood disorder can expand Sanofi’s hematology portfolio and differentiate the product against existing therapies that use other modes of action.

Because the therapy is described as the first BTK inhibitor for this indication in the EU, Sanofi may face limited direct class competition initially, which can help positioning with physicians and payers. Actual commercial impact will depend on label details, pricing, reimbursement decisions, and how quickly clinicians adopt BTK inhibition in this setting.

The key future elements relate to how Sanofi implements the EU launch following the December 2025 press release, including country-by-country market access and uptake among immune thrombocytopenia patients. Subsequent company materials may provide data on sales, patient reach, or any additional regulatory decisions in other regions.

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 December 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 December 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 December 23, 2025: Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia

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

3

FAQ

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

Sanofi reported that it published a press release dated December 23, 2025 announcing that Wayrilz was approved in the European Union as the first BTK inhibitor to treat immune thrombocytopenia.

What is Wayrilz and what condition is it approved to treat in the EU?

Wayrilz is a Sanofi medicine described as the first BTK inhibitor approved in the European Union to treat immune thrombocytopenia, a disorder characterized by low platelet levels.

Why is the EU approval of Wayrilz important for Sanofi (SNY)?

The EU approval gives Sanofi a first-in-class BTK inhibitor for immune thrombocytopenia, potentially strengthening its rare disease and hematology franchise with a novel treatment option.

When was the press release about Wayrilz’s EU approval issued?

The press release titled “Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia” is dated December 23, 2025.

Does the Form 6-K include financial details about Wayrilz for Sanofi (SNY)?

The Form 6-K primarily forwards the press release announcing Wayrilz’s EU approval for immune thrombocytopenia and focuses on the regulatory milestone rather than financial metrics.

Where can investors find more details on Wayrilz’s EU approval mentioned by Sanofi (SNY)?

More details are contained in Exhibit 99.1 to the report, which is the Sanofi press release dated December 23, 2025 about Wayrilz’s EU approval for immune thrombocytopenia.