Waldencast (WALDW) wins FDA approval for Obagi saypha MagIQ injectable gel

Rhea-AI Filing Summary

Waldencast plc submitted a Form 6-K to furnish a company announcement dated September 10, 2025. The announcement, attached as Exhibit 99.1, states that Waldencast has received FDA approval for the Obagi® saypha® MagIQ™ Injectable Hyaluronic Acid Gel under the Obagi Medical brand.

The report clarifies that this information is being furnished, not filed, and will only be incorporated into other securities filings if specifically referenced.

Positive

• FDA approval of new Obagi Medical product: The company reports U.S. FDA approval of Obagi® saypha® MagIQ™ Injectable Hyaluronic Acid Gel under the Obagi Medical brand, adding a new regulated injectable aesthetic product to its portfolio.

Negative

• None.

Insights

Healthcare equities analyst

FDA approval expands Waldencast’s Obagi Medical product portfolio in the U.S.

Waldencast reports that the FDA has approved Obagi® saypha® MagIQ™ Injectable Hyaluronic Acid Gel under the Obagi Medical brand. FDA approvals are important regulatory milestones because they permit commercialization of new medical-grade aesthetic products in the U.S. market.

The filing itself does not disclose financial projections, pricing, or market size, so the direct revenue impact is not quantified. However, adding an FDA-approved injectable gel broadens Obagi Medical’s offering and may support future growth, depending on physician adoption and competitive dynamics.

Subsequent company communications or periodic reports may provide more detail on launch timing, marketing strategy, and early sales trends for Obagi® saypha® MagIQ™ Injectable Hyaluronic Acid Gel.

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: 001-40207

Waldencast plc

(Translation of Registrant’s name into English)

81 Fulham Road

London, SW3 6RD

United Kingdom

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

☒ Form 20-F ☐ Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

1

Press Release

On September 10, 2025, Waldencast plc (the “Company”) issued an announcement titled “Waldencast Announces FDA Approval of Obagi® saypha® MagIQ™ Injectable Hyaluronic Acid Gel Under the Obagi Medical Brand”, a copy of which is attached as Exhibit 99.1 to this Form 6-K.

The information in this report on Form 6-K (including Exhibit 99.1 hereto) (“Report”) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

EXHIBIT INDEX

EXHIBIT NO.						DESCRIPTION
99.1						Company announcement dated September 10, 2025, “Waldencast Announces FDA Approval of Obagi® saypha® MagIQ™ Injectable Hyaluronic Acid Gel Under the Obagi Medical Brand”

2

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, Waldencast plc has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

						Waldencast plc
						(Registrant)
Date: September 10, 2025			By:			/s/ Manuel Manfredi
						Name:			Manuel Manfredi
						Title:			Chief Financial Officer and Principal Financial Officer

3

FAQ

What did Waldencast plc (WALDW) report in its September 2025 Form 6-K?

Waldencast plc reported that it issued an announcement on September 10, 2025, regarding FDA approval of Obagi® saypha® MagIQ™ Injectable Hyaluronic Acid Gel under the Obagi Medical brand, furnished as Exhibit 99.1 to the Form 6-K.

What FDA approval did Waldencast plc (WALDW) disclose for the Obagi brand?

Waldencast disclosed FDA approval of Obagi® saypha® MagIQ™ Injectable Hyaluronic Acid Gel under the Obagi Medical brand. This approval allows marketing of the injectable hyaluronic acid gel in the U.S., expanding Obagi Medical’s professional skincare and aesthetic treatment portfolio.

Is the Waldencast plc (WALDW) FDA approval information considered filed or furnished?

The company states the information in this Form 6-K, including Exhibit 99.1, is furnished rather than filed for purposes of Section 18 of the Exchange Act and is only incorporated into other securities filings if specifically referenced by Waldencast.

What exhibit is attached to Waldencast plc’s (WALDW) September 2025 Form 6-K?

The Form 6-K attaches Exhibit 99.1, a company announcement dated September 10, 2025, titled “Waldencast Announces FDA Approval of Obagi® saypha® MagIQ™ Injectable Hyaluronic Acid Gel Under the Obagi Medical Brand,” providing more detail on the approval.

Who signed Waldencast plc’s (WALDW) September 2025 Form 6-K?

The Form 6-K was signed on behalf of Waldencast plc by Manuel Manfredi, who is identified as the company’s Chief Financial Officer and Principal Financial Officer, confirming authorization of the report under the Securities Exchange Act of 1934.

Does Waldencast plc (WALDW) provide financial figures in this FDA-related 6-K?

This Form 6-K does not present financial results or earnings data. It focuses on furnishing the company’s announcement about FDA approval of Obagi® saypha® MagIQ™ Injectable Hyaluronic Acid Gel, rather than detailing revenues, profits, or quantitative financial metrics.