SNY: Wayrilz Approved in US as First BTK Inhibitor for ITP

Rhea-AI Filing Summary

Sanofi (SNY) filed a Form 6-K that includes an exhibit: a press release dated August 29, 2025 announcing that Wayrilz was approved in the United States as the first BTK inhibitor indicated for immune thrombocytopenia. The filing itself is dated September 3, 2025 and is signed by Alexandra Roger, Head of Legal Corporate & Finance.

The disclosure is concise: it notifies investors that a regulatory approval milestone was achieved for a new therapeutic option in immune thrombocytopenia and that the company has publicly released that information via a press release attached as Exhibit 99.1.

Positive

• U.S. regulatory approval achieved for Wayrilz (first BTK inhibitor for immune thrombocytopenia)
• First‑in‑class positioning as the initial BTK inhibitor approved for this indication

Negative

• None.

Insights

Regulatory Affairs Analyst

Approval secures a US regulatory milestone for Sanofi's BTK program.

The United States approval of Wayrilz as the first BTK inhibitor for immune thrombocytopenia creates a new, FDA‑authorized treatment category for this indication. Regulatory clearance typically enables product launch planning, labeling, and reimbursement discussions that can convert approval into commercial availability.

Near‑term dependencies include completion of labeling, distribution setup, and payer discussions; monitor company statements on launch timing and expected availability in the coming months.

Commercial Strategy Specialist

Market impact will depend on rollout speed and payer coverage.

Being the first approved BTK inhibitor for immune thrombocytopenia may provide first‑mover advantages in physician awareness and formulary positioning. Commercial success will depend on pricing, reimbursement, and physician uptake compared with existing therapies for the condition.

Watch for announcements on launch timing, recommended pricing, and any distribution or access programs over the next several months to a year.

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 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 29, 2025: Sanofi’s Wayrilz approved in US as first BTK inhibitor for 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: September 3, 2025						SANOFI
				By		/s/ Alexandra Roger
						Name: Alexandra Roger
						Title: Head of Legal Corporate & Finance

3

FAQ

What did Sanofi (SNY) disclose in this 6‑K?

The filing attaches a press release dated August 29, 2025 stating that Wayrilz was approved in the United States as the first BTK inhibitor for immune thrombocytopenia.

When was the press release announcing Wayrilz approval issued?

The press release is dated August 29, 2025 and the Form 6‑K is dated September 3, 2025.

Who signed the Form 6‑K for Sanofi?

The report is signed by Alexandra Roger, Head of Legal Corporate & Finance.

Does the filing include commercial or launch details for Wayrilz?

No. The filing lists the press release announcing approval but does not provide pricing, launch timing, or distribution details.

Is Wayrilz described as a first‑in‑class therapy?

The press release states Wayrilz is the first BTK inhibitor approved in the U.S. for immune thrombocytopenia.