Waldencast's Obagi Gets FDA Nod for New Injectable
Ticker: WALDW · Form: 6-K · Filed: Sep 10, 2025 · CIK: 1840199
| Field | Detail |
|---|---|
| Company | Waldencast PLC (WALDW) |
| Form Type | 6-K |
| Filed Date | Sep 10, 2025 |
| Risk Level | low |
| Pages | 1 |
| Reading Time | 1 min |
| Sentiment | bullish |
Sentiment: bullish
Topics: fda-approval, product-launch, cosmetics, medical-devices
TL;DR
Waldencast's Obagi filler just got FDA approved for the US market. Big win for aesthetics.
AI Summary
On September 10, 2025, Waldencast plc announced that its Obagi brand received FDA approval for its new product, Obagi® saypha® MagIQ™ Injectable Hyaluronic Acid Gel. This approval allows the product to be marketed and sold in the United States.
Why It Matters
FDA approval for Obagi® saypha® MagIQ™ opens up the significant US market for this new hyaluronic acid filler, potentially boosting Waldencast's revenue and market share in the aesthetics sector.
Risk Assessment
Risk Level: low — This is a routine regulatory filing announcing product approval, with no immediate financial or operational risks indicated.
Key Players & Entities
- Waldencast plc (company) — Filer of the 6-K report
- Obagi (company) — Brand whose product received FDA approval
- Obagi® saypha® MagIQ™ Injectable Hyaluronic Acid Gel (product) — Product that received FDA approval
- FDA (company) — Regulatory body that granted approval
- September 10, 2025 (date) — Date of the announcement
FAQ
What is the specific product that received FDA approval?
The product that received FDA approval is the Obagi® saypha® MagIQ™ Injectable Hyaluronic Acid Gel.
Which company's brand received the FDA approval?
The Obagi brand, which is part of Waldencast plc, received the FDA approval.
On what date was this FDA approval announced?
The announcement of the FDA approval was made on September 10, 2025.
What is the significance of this FDA approval for Waldencast plc?
The FDA approval allows the Obagi® saypha® MagIQ™ product to be marketed and sold in the United States, opening up a significant market.
What type of product is Obagi® saypha® MagIQ™?
Obagi® saypha® MagIQ™ is an Injectable Hyaluronic Acid Gel.
Filing Stats: 336 words · 1 min read · ~1 pages · Grade level 17.8 · Accepted 2025-09-10 07:26:58
Filing Documents
- 6k.htm (6-K) — 13KB
- ex99-1.htm (EX-99.1) — 19KB
- image0.jpg (GRAPHIC) — 113KB
- 0001341004-25-000082.txt ( ) — 190KB
From the Filing
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