1. Biofrontera acquired Ameluz® NDA and IND, gaining regulatory control. 2. 11 US patents and 19 international patent applications transferred to Biofrontera. 3. $11 million investment supports Biofrontera's asset transfer completion. 4. Successful transfer strengthens Biofrontera's market position in dermatological treatments. 5. CEO highlights potential for operational efficiency and R&D optimization.
FAQ
Why Bullish?
The acquisition of regulatory control and patents enhances Biofrontera's market potential. Historical examples like gene therapy approvals show stock price increases post-regulatory control.
How important is it?
The article details significant operational changes that directly affect revenue potential, making it highly relevant.
Why Short Term?
Immediate operational control likely to drive short-term stock performance, similar to reactions seen after product approval announcements.
Biofrontera Inc. Completes Transfer of FDA Approvals for Ameluz® and RhodoLED®
WOBURN, Mass., Dec. 18, 2025 (GLOBE NEWSWIRE) — Biofrontera Inc. (Nasdaq: BFRI), a prominent player in photodynamic therapy (PDT), has successfully transferred FDA approvals for its flagship products Ameluz® and the RhodoLED® Lamp Series. This strategic move includes the transfer of the New Drug Application (NDA) and Investigational New Drug Application (IND) to Biofrontera, empowering the company to independently manage its clinical development and marketing efforts.
Details of the Transfer
As part of the comprehensive transfer, Biofrontera has also acquired:
- 11 granted US patents
- 10 pending US patent applications
- 19 international patent applications and/or registered designs for RhodoLED® lamps outside the US
Additionally, the registration of all associated trademarks has been initiated with the relevant authorities, including the US Patent Office (USPTO). This acquisition strengthens Biofrontera's intellectual property and positions it effectively in the competitive market.
Financial Backing for Strategic Growth
The asset transfers were supported in part by a recent $11.0 million investment, which highlights investor confidence in Biofrontera's future prospects. With the NDA and IND transfers effective from December 17, 2025, Biofrontera is now fully responsible for all aspects related to Ameluz® and RhodoLED® in the US.
CEO Statement on Milestone Achievement
Dr. Hermann Luebbert, CEO and Chairman of Biofrontera, commented on this significant milestone, stating, “This achievement represents the next important milestone in the transformative arrangement we initiated in June 2025. By consolidating control of Ameluz’s US regulatory filings and its robust patent portfolio, we are positioned to drive operational efficiencies, optimize R&D expenditures, swiftly pursue new indications, and continue refining our RhodoLED® lamp platform — to meet and exceed the evolving needs of clinicians and patients.”
About Biofrontera Inc.
Biofrontera Inc. specializes in developing innovative treatments for dermatological conditions, particularly through its PDT expertise. The company is known for the drug-device combination, Ameluz®, alongside the RhodoLED® lamp series, specifically targeting Actinic Keratosis—a condition that may lead to invasive skin cancers. Biofrontera also conducts clinical trials aimed at broadening its product applications to include treatments for non-melanoma skin cancers and moderate to severe acne.
Conclusion and Forward-Looking Statements
This successful transfer marks a pivotal moment for BFRI as it solidifies its foothold in the biopharmaceutical landscape. Investors and stakeholders should remain aware of the potential forward-looking statements that may arise from the company’s ongoing efforts and strategies in the evolving dermatological treatment space.
For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and X.