Biofrontera Completes Phase 1 Study of Ameluz®; Plans FDA Submission for 2026
- Research Milestone: Biofrontera has completed its Phase 1 pharmacokinetic study of Ameluz®, involving 17 patients applying three tubes over a treatment area of 240 cm², marking a significant step towards a planned FDA submission in summer 2026.
- Market Demand: The study results will be combined with data from a recently completed Phase 3 trial to support a supplemental New Drug Application (sNDA) to the FDA, aiming to expand Ameluz®'s indications to all peripheral body areas, addressing a critical need in dermatology.
- Patient Benefits: If approved, this indication expansion will provide significant treatment options for patients, and Biofrontera anticipates that it will greatly enhance its leadership position in the photodynamic therapy market.
- Industry Impact: With approximately 58 million people affected by actinic keratosis in the U.S. as of 2020, Ameluz® could become a key drug for treating this common skin lesion if approved, further driving the company's business growth.
Trade with 70% Backtested Accuracy
Analyst Views on BFRI
About BFRI
About the author
Biofrontera Reports Record Q4 Revenue of $17.5 Million, Driven by Ameluz® Sales
- Record Revenue: Biofrontera's Q4 revenue is projected to reach $17.5 million, representing a 35% year-over-year increase, marking the highest quarterly revenue in the company's history and showcasing significant sales execution improvements.
- Annual Growth Outlook: Full-year 2025 revenues are expected to range between $41.5 million and $42.0 million, reflecting an 11% to 13% year-over-year growth rate, indicating the company's sustained growth potential and stable business foundation.
- Strong Customer Engagement: CEO Hermann Luebbert noted that strong customer adoption and engagement throughout Q4 supported record revenue performance, validating the company's strategic direction and setting the stage for stronger momentum in 2026.
- Margin Improvement: The recent transaction with Biofrontera AG significantly enhances the company's gross margin profile, further strengthening its financial foundation and instilling confidence in future growth, which is expected to drive continued sustainable growth.
Baidu Inc Proposes Spinoff of Kunlunxin H Shares, Stock Rises 12.3%
- Stock Surge: Baidu's announcement of a proposed spinoff of Kunlunxin (Beijing) Technology Co., Ltd. H shares for a separate listing on the Hong Kong Stock Exchange led to a 12.3% increase in its stock price to $146.69 in pre-market trading, indicating strong market enthusiasm for this strategic move.
- Spinoff Strategy: The spinoff aims to enhance Kunlunxin's independence and market valuation, which is expected to provide Baidu with more flexible capital operations and resource allocation, thereby strengthening its competitive position in the technology sector.
- Market Reaction: The spinoff news has sparked investor excitement, with the significant rise in Baidu's stock reflecting confidence in its future growth potential and likely attracting more institutional investors to its shares.
- Industry Impact: By pursuing this spinoff, Baidu can focus more on its core business while providing Kunlunxin with greater development space, which is anticipated to drive innovation and investment activity across the technology industry.
Biofrontera Completes Transfer of Ameluz® NDA and Patents for $11M Investment
- Asset Transfer Completion: Biofrontera successfully transferred the NDA and IND for Ameluz® and the RhodoLED® lamp series, effective December 17, 2025, enabling full control over clinical development activities and enhancing market competitiveness.
- Intellectual Property Enhancement: The company also transferred 11 granted US patents and 10 pending applications, further strengthening its intellectual property portfolio in the US, which is expected to drive future R&D and market expansion.
- International Patent Strategy: Biofrontera acquired 19 international patent applications, with registration transfers initiated, which will aid in global market expansion and enhance its international competitiveness.
- Strategic Investment Support: This transfer aligns with the recent $11 million investment, demonstrating Biofrontera's strategic commitment to dermatological treatments and aiming to optimize R&D expenditures while swiftly pursuing new indications.
Biofrontera Completes Phase 1 Study of Ameluz®; Plans FDA Submission for 2026
- Research Milestone: Biofrontera has completed its Phase 1 pharmacokinetic study of Ameluz®, involving 17 patients applying three tubes over a treatment area of 240 cm², marking a significant step towards a planned FDA submission in summer 2026.
- Market Demand: The study results will be combined with data from a recently completed Phase 3 trial to support a supplemental New Drug Application (sNDA) to the FDA, aiming to expand Ameluz®'s indications to all peripheral body areas, addressing a critical need in dermatology.
- Patient Benefits: If approved, this indication expansion will provide significant treatment options for patients, and Biofrontera anticipates that it will greatly enhance its leadership position in the photodynamic therapy market.
- Industry Impact: With approximately 58 million people affected by actinic keratosis in the U.S. as of 2020, Ameluz® could become a key drug for treating this common skin lesion if approved, further driving the company's business growth.
Biofrontera Inc. Announces Financial Results for Q3 2025 and Offers Business Update
Financial Performance: Biofrontera Inc. reported stable revenues of $24.6 million for the first nine months of 2025, slightly down from $24.8 million in 2024, with a notable decline in Q3 revenues to $7.0 million due to advanced purchases ahead of a price increase.
Operational Developments: The company completed the acquisition of U.S. rights for Ameluz and RhodoLED assets, which is expected to enhance gross margins and profitability, and announced the divestiture of its Xepi antibiotic cream for up to $10 million in total payments.
Clinical Trials Update: Biofrontera announced the completion of the active treatment phase for its Phase 3 clinical trial of Ameluz for actinic keratoses and the conclusion of participation in a Phase 2b trial for acne vulgaris.
Future Outlook: CEO Hermann Luebbert expressed confidence in achieving full-year sales objectives, anticipating substantial growth in Q4, supported by a revamped sales strategy and increasing demand for Ameluz-PDT treatments.
EXCLUSIVE: Pelthos Acquires Antimicrobial Drug Rights and Raises $18 Million for Commercial Launch Support
Acquisition of Xepi: Pelthos Therapeutics Inc. has acquired U.S. commercialization rights to Xepi (ozenoxacin) Cream from Biofrontera Inc. and Ferrer Internacional S.A. for a total of $4.2 million, with plans to relaunch the product in late 2026.
Product Details: Xepi is a topical antimicrobial treatment for impetigo, a contagious skin infection affecting around 3 million people in the U.S. annually, particularly children aged 2 to 5.
Funding for Commercialization: Pelthos has secured $18 million in private convertible notes financing to support the acquisition and relaunch of Xepi, as well as to accelerate the commercialization of another product, Zelsuvmi.
Market Response: Following the acquisition announcement, Pelthos Therapeutics shares remained stable at $37.42 during premarket trading, indicating limited movement in the stock price.
Biofrontera Reports Record Q4 Revenue of $17.5 Million, Driven by Ameluz® Sales
- Record Revenue: Biofrontera's Q4 revenue is projected to reach $17.5 million, representing a 35% year-over-year increase, marking the highest quarterly revenue in the company's history and showcasing significant sales execution improvements.
- Annual Growth Outlook: Full-year 2025 revenues are expected to range between $41.5 million and $42.0 million, reflecting an 11% to 13% year-over-year growth rate, indicating the company's sustained growth potential and stable business foundation.
- Strong Customer Engagement: CEO Hermann Luebbert noted that strong customer adoption and engagement throughout Q4 supported record revenue performance, validating the company's strategic direction and setting the stage for stronger momentum in 2026.
- Margin Improvement: The recent transaction with Biofrontera AG significantly enhances the company's gross margin profile, further strengthening its financial foundation and instilling confidence in future growth, which is expected to drive continued sustainable growth.
Baidu Inc Proposes Spinoff of Kunlunxin H Shares, Stock Rises 12.3%
- Stock Surge: Baidu's announcement of a proposed spinoff of Kunlunxin (Beijing) Technology Co., Ltd. H shares for a separate listing on the Hong Kong Stock Exchange led to a 12.3% increase in its stock price to $146.69 in pre-market trading, indicating strong market enthusiasm for this strategic move.
- Spinoff Strategy: The spinoff aims to enhance Kunlunxin's independence and market valuation, which is expected to provide Baidu with more flexible capital operations and resource allocation, thereby strengthening its competitive position in the technology sector.
- Market Reaction: The spinoff news has sparked investor excitement, with the significant rise in Baidu's stock reflecting confidence in its future growth potential and likely attracting more institutional investors to its shares.
- Industry Impact: By pursuing this spinoff, Baidu can focus more on its core business while providing Kunlunxin with greater development space, which is anticipated to drive innovation and investment activity across the technology industry.
Biofrontera Completes Transfer of Ameluz® NDA and Patents for $11M Investment
- Asset Transfer Completion: Biofrontera successfully transferred the NDA and IND for Ameluz® and the RhodoLED® lamp series, effective December 17, 2025, enabling full control over clinical development activities and enhancing market competitiveness.
- Intellectual Property Enhancement: The company also transferred 11 granted US patents and 10 pending applications, further strengthening its intellectual property portfolio in the US, which is expected to drive future R&D and market expansion.
- International Patent Strategy: Biofrontera acquired 19 international patent applications, with registration transfers initiated, which will aid in global market expansion and enhance its international competitiveness.
- Strategic Investment Support: This transfer aligns with the recent $11 million investment, demonstrating Biofrontera's strategic commitment to dermatological treatments and aiming to optimize R&D expenditures while swiftly pursuing new indications.
Biofrontera Completes Phase 1 Study of Ameluz®; Plans FDA Submission for 2026
- Research Milestone: Biofrontera has completed its Phase 1 pharmacokinetic study of Ameluz®, involving 17 patients applying three tubes over a treatment area of 240 cm², marking a significant step towards a planned FDA submission in summer 2026.
- Market Demand: The study results will be combined with data from a recently completed Phase 3 trial to support a supplemental New Drug Application (sNDA) to the FDA, aiming to expand Ameluz®'s indications to all peripheral body areas, addressing a critical need in dermatology.
- Patient Benefits: If approved, this indication expansion will provide significant treatment options for patients, and Biofrontera anticipates that it will greatly enhance its leadership position in the photodynamic therapy market.
- Industry Impact: With approximately 58 million people affected by actinic keratosis in the U.S. as of 2020, Ameluz® could become a key drug for treating this common skin lesion if approved, further driving the company's business growth.
Biofrontera Inc. Announces Financial Results for Q3 2025 and Offers Business Update
Financial Performance: Biofrontera Inc. reported stable revenues of $24.6 million for the first nine months of 2025, slightly down from $24.8 million in 2024, with a notable decline in Q3 revenues to $7.0 million due to advanced purchases ahead of a price increase.
Operational Developments: The company completed the acquisition of U.S. rights for Ameluz and RhodoLED assets, which is expected to enhance gross margins and profitability, and announced the divestiture of its Xepi antibiotic cream for up to $10 million in total payments.
Clinical Trials Update: Biofrontera announced the completion of the active treatment phase for its Phase 3 clinical trial of Ameluz for actinic keratoses and the conclusion of participation in a Phase 2b trial for acne vulgaris.
Future Outlook: CEO Hermann Luebbert expressed confidence in achieving full-year sales objectives, anticipating substantial growth in Q4, supported by a revamped sales strategy and increasing demand for Ameluz-PDT treatments.
EXCLUSIVE: Pelthos Acquires Antimicrobial Drug Rights and Raises $18 Million for Commercial Launch Support
Acquisition of Xepi: Pelthos Therapeutics Inc. has acquired U.S. commercialization rights to Xepi (ozenoxacin) Cream from Biofrontera Inc. and Ferrer Internacional S.A. for a total of $4.2 million, with plans to relaunch the product in late 2026.
Product Details: Xepi is a topical antimicrobial treatment for impetigo, a contagious skin infection affecting around 3 million people in the U.S. annually, particularly children aged 2 to 5.
Funding for Commercialization: Pelthos has secured $18 million in private convertible notes financing to support the acquisition and relaunch of Xepi, as well as to accelerate the commercialization of another product, Zelsuvmi.
Market Response: Following the acquisition announcement, Pelthos Therapeutics shares remained stable at $37.42 during premarket trading, indicating limited movement in the stock price.
