Biofrontera Inc. Completes Transfer of Ameluz® and RhodoLED® FDA approval and Associated Intellectual Property Portfolio

Rhea-AI Summary

Biofrontera (Nasdaq: BFRI) completed transfer of the Ameluz NDA and IND and FDA approvals, effective December 17, 2025, giving the company full US regulatory control for Ameluz and the RhodoLED lamp series.

The company also filed assignments for US trademarks and completed transfer filings for intellectual property including 11 granted US patents, 10 US patent applications and 19 international patent filings/registered designs. These transfers were secured in part by an $11.0 million investment.

Positive

• NDA and IND transfers effective December 17, 2025
• Acquired 11 granted US patents tied to Ameluz and RhodoLED
• Filed assignment for 10 US patent applications
• Added 19 international patent filings/registered designs
• Asset transfers secured partly by an $11.0 million investment

Negative

• None.

Key Figures

US granted patents 11 Ameluz and RhodoLED intellectual property transferred to Biofrontera Inc.

US patent applications 10 Pending US patent applications for Ameluz and RhodoLED portfolio

International filings 19 International patent applications and/or registered designs for RhodoLED lamps

Investment backing transfer $11.0 million Investment that helped secure NDA/IND and IP transfers

Market Reality Check

$0.0700 Last Close

Volume Volume 44,793 is below the 20-day average of 104,599, showing muted pre-news activity. low

Technical Price $0.7201 was trading below the 200-day MA of $0.85 ahead of this news.

Peers on Argus 2 Up

Peers showed mixed action: names like YCBD and INM appeared on momentum scanners moving up, while BFRI’s price was down 2.01% pre‑announcement, suggesting a stock-specific setup rather than a broad sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 04	Clinical trial update	Positive	+3.2%	Completion of Phase 1 PK study for Ameluz on trunk and extremities.
Dec 02	sNDA submission	Positive	-0.1%	Filing sNDA for Ameluz-PDT in superficial basal cell carcinoma.
Nov 13	Earnings and update	Negative	-8.6%	Q3 2025 revenue decline, losses and going-concern language disclosed.
Nov 07	Asset sale	Positive	-6.9%	Sale of Xepi U.S. license for up to $10M to refocus on PDT.
Nov 06	Earnings call notice	Neutral	+6.4%	Announcement of Q3 2025 earnings release and investor call schedule.

Pattern Detected

Recent news shows mixed reactions: positive clinical and deal updates twice saw negative price moves, while other positive and negative events aligned with subsequent trading.

Recent Company History

Over the last months, Biofrontera reported multiple milestones tied to Ameluz and its PDT platform. A Phase 1 PK study completion on Dec 4, 2025 saw a 3.2% gain, while an sNDA for sBCC on Nov 28, 2025 coincided with a slight -0.11% move. Q3 results on Nov 13, 2025 highlighted revenue pressure and going-concern disclosure with a -8.59% reaction. The Xepi license sale on Nov 7, 2025 led to a -6.9% move. Today’s FDA/IP transfer further consolidates Ameluz’s U.S. position following these steps.

Market Pulse Summary

This announcement completes the transfer of FDA approvals, NDA/INDs, and a portfolio of 11 granted US patents, 10 US applications, and 19 international filings for Ameluz and RhodoLED to Biofrontera Inc., backed by an $11.0 million investment. It builds on earlier steps like Orange Book patent listing and U.S. rights acquisition. Investors may watch future clinical updates, U.S. sales trends, and additional regulatory milestones around Ameluz’s expanded indications.

Key Terms

new drug application (nda) regulatory

"Ameluz® and RhodoLED® New Drug Application (NDA) and Investigational..."

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

investigational new drug application (ind) regulatory

"New Drug Application (NDA) and Investigational New Drug Application (IND)..."

An investigational new drug application (IND) is a formal request made to regulatory authorities to begin testing a new medicine in humans. It is a crucial step in the drug development process, allowing companies to conduct clinical trials to determine if the drug is safe and effective. For investors, an IND signals progress in the drug's development, which can influence a company's potential growth and valuation.

fda regulatory

"completion of the transfer of the FDA approvals for Ameluz® and the RhodoLED®..."

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

us patent office (uspto) regulatory

"applied for registration with the relevant authorities, including the US Patent Office (USPTO)..."

The United States Patent and Trademark Office is the federal agency that examines and issues patents and registers trademarks, giving inventors legal rights to block others from making, using or selling a protected invention or brand. For investors, USPTO decisions matter because patents and trademarks can act like a protective fence around products and technologies, shaping a company’s competitive edge, potential revenue from sales or licenses, and overall valuation.

photodynamic therapy (pdt) medical

"a leader in photodynamic therapy (PDT) development and commercialization..."

Photodynamic therapy (PDT) is a medical treatment that uses special light-sensitive drugs and a light source to target and destroy abnormal or cancerous cells. It works like a precise spotlight, activating the drug only in the affected area to minimize damage to surrounding tissue. While primarily a health care method, its development and adoption can influence biotech and pharmaceutical markets, making it relevant for investors tracking advancements in medical technology.

AI-generated analysis. Not financial advice.

• Ameluz^® and RhodoLED^® New Drug Application (NDA) and Investigational New Drug Application (IND) have successfully been transferred to Biofrontera Inc.
• Assignment to Biofrontera Inc. of 11 granted US patents, 10 pending US patent applications and various trademarks associated with Ameluz^® and the RhodoLED^® Lamp Series has been applied for registration with the relevant authorities, including the US Patent Office (USPTO)
• In addition, 19 international patent applications and/or registered designs for RhodoLED^® lamps outside of the US were acquired and registration of the transfer has been initiated

WOBURN, Mass., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a leader in photodynamic therapy (PDT) development and commercialization, today announced the completion of the transfer of the FDA approvals for Ameluz^® and the RhodoLED^® Lamp Series, including the NDA and the Investigational New Drug Application (IND), to Biofrontera. In addition, the Company has completed all necessary filings to transfer all US and some international intellectual property associated with Ameluz^® and the RhodoLED^® Lamp Series, including 11 granted US patents, 10 US patent applications, and 19 patent filings or registered designs outside of the US. The registration of the assignment to Biofrontera of all associated trademarks has also been initiated. These asset transfers were secured, in part, by an $11.0 million investment recently reported by the Company.

With the NDA and IND transfers effective as of December 17, 2025, Biofrontera now assumes full control of the Ameluz^® NDA and IND, enabling the Company to manage ongoing and future clinical development activities independently, and to take full responsibility for all aspects of manufacturing and marketing Ameluz^® and the RhodoLED^® lamps in the US. The patent and trademark transfers further strengthen Biofrontera’s intellectual property portfolio and market position in the US.

“This achievement represents the next important milestone in the transformative arrangement we initiated in June 2025,” said Dr. Hermann Luebbert, CEO and Chairman of Biofrontera. “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 is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz^® with the RhodoLED^® lamp series for PDT of Actinic Keratosis, pre-cancerous skin lesions which may progress to invasive skin cancers¹. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and X.

References
1 https://www.skincancer.org/skin-cancer-information/actinic-keratosis/

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz^® in combination with BF-RhodoLED^® and/or RhodoLED^® XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the impact of any extraordinary external events; the Company’s ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company’s ability to obtain and distribute its products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s products; whether the market opportunity for Ameluz ^® in combination with BF- RhodoLED^® and/or RhodoLED^® XL is consistent with the Company’s expectations; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), which can be obtained on the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

Investor Relations
Ben Shamsian
646-829-9701
shamsian@lythampartners.com

FAQ

When did Biofrontera (BFRI) assume US regulatory control of Ameluz and RhodoLED?

The NDA and IND transfers became effective on December 17, 2025.

How many US patents did Biofrontera (BFRI) acquire for Ameluz and RhodoLED?

Biofrontera acquired 11 granted US patents related to Ameluz and RhodoLED.

What intellectual property filings did Biofrontera (BFRI) complete in the US?

The company completed filings to transfer 11 granted US patents and 10 US patent applications, plus trademark assignment filings.

Did Biofrontera (BFRI) acquire international IP for RhodoLED lamps?

Yes; Biofrontera acquired and initiated registration for 19 international patent filings or registered designs for RhodoLED lamps.

How was the Ameluz and RhodoLED asset transfer financed by Biofrontera (BFRI)?

The asset transfers were secured, in part, by an investment of $11.0 million.

What operational responsibilities does Biofrontera (BFRI) now hold for Ameluz in the US?

Biofrontera now controls ongoing and future clinical development and is responsible for manufacturing and marketing Ameluz and RhodoLED lamps in the US.