Biofrontera Reports Positive Phase 3 Trial Results for Ameluz PDT
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
0mins
Should l Buy BFRI?
Source: NASDAQ.COM
- Clinical Trial Results: Biofrontera Inc. announced positive outcomes from its Phase 3 clinical trial, demonstrating Ameluz PDT's efficacy in treating mild to moderate actinic keratoses, achieving a complete clearance rate of 45.6%, significantly higher than the 16.7% in the control group.
- Market Reaction: Despite the positive trial results, Biofrontera's stock fell by 8.66% to $0.75, indicating market concerns regarding future profitability, with an opening price of $0.70 and a session high of $0.96.
- FDA Application Plans: Based on the clinical data, Biofrontera plans to submit a supplemental New Drug Application to the U.S. FDA in the third quarter of 2026, aiming to further advance Ameluz's market access.
- Patient Satisfaction: Ameluz PDT not only showed superior efficacy but also favorable cosmetic outcomes and high patient satisfaction, which may enhance the product's competitive position in the market.
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Analyst Views on BFRI
Wall Street analysts forecast BFRI stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for BFRI is 6.00 USD with a low forecast of 3.00 USD and a high forecast of 9.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.821
Low
3.00
Averages
6.00
High
9.00
Current: 0.821
Low
3.00
Averages
6.00
High
9.00
About BFRI
Biofrontera Inc. is a biopharmaceutical company. The Company specializes in the development and commercialization of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (PDT). The PDT treatment is used for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp. The Company’s primary licensed products, which include Ameluz as well as the BF-RhodoLED and RhodoLED XL lamps (the RhodoLED Lamps), are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions. The Company commercializes the drug-device combination Ameluz with the RhodoLED lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. Its belixos ACTIVE CARE is a skin-soothing care foam for irritated and itchy skin, which can be used as basic care for atopic dermatitis and psoriasis as well as for soothing intensive care for everyday skin problems.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Biofrontera Reports Positive Phase 3 Trial Results for Ameluz PDT
- Clinical Trial Results: Biofrontera Inc. announced positive outcomes from its Phase 3 clinical trial, demonstrating Ameluz PDT's efficacy in treating mild to moderate actinic keratoses, achieving a complete clearance rate of 45.6%, significantly higher than the 16.7% in the control group.
- Market Reaction: Despite the positive trial results, Biofrontera's stock fell by 8.66% to $0.75, indicating market concerns regarding future profitability, with an opening price of $0.70 and a session high of $0.96.
- FDA Application Plans: Based on the clinical data, Biofrontera plans to submit a supplemental New Drug Application to the U.S. FDA in the third quarter of 2026, aiming to further advance Ameluz's market access.
- Patient Satisfaction: Ameluz PDT not only showed superior efficacy but also favorable cosmetic outcomes and high patient satisfaction, which may enhance the product's competitive position in the market.
See More
Biofrontera's Ameluz® Clinical Trial Shows Significant Success
- Clinical Trial Results: Biofrontera's Ameluz® demonstrated a significant increase in complete clearance rates of 45.6% compared to the control group in its Phase 3 trial for mild to moderate actinic keratosis (p<0.0003), establishing a strong foundation for market promotion.
- Efficacy Assessment: In the Full Analysis Set (FAS), 73.1% of patients showed lesion clearance 12 weeks post-treatment, indicating Ameluz®'s effectiveness in treating actinic keratosis, which may attract more attention from physicians and patients alike.
- Patient Satisfaction: 75.2% of patients rated the aesthetic appearance of their skin as
See More
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.
See More
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.
See More
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.
See More
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.
See More
Biofrontera Reports Positive Phase 3 Trial Results for Ameluz PDT
- Clinical Trial Results: Biofrontera Inc. announced positive outcomes from its Phase 3 clinical trial, demonstrating Ameluz PDT's efficacy in treating mild to moderate actinic keratoses, achieving a complete clearance rate of 45.6%, significantly higher than the 16.7% in the control group.
- Market Reaction: Despite the positive trial results, Biofrontera's stock fell by 8.66% to $0.75, indicating market concerns regarding future profitability, with an opening price of $0.70 and a session high of $0.96.
- FDA Application Plans: Based on the clinical data, Biofrontera plans to submit a supplemental New Drug Application to the U.S. FDA in the third quarter of 2026, aiming to further advance Ameluz's market access.
- Patient Satisfaction: Ameluz PDT not only showed superior efficacy but also favorable cosmetic outcomes and high patient satisfaction, which may enhance the product's competitive position in the market.
See More
Biofrontera's Ameluz® Clinical Trial Shows Significant Success
- Clinical Trial Results: Biofrontera's Ameluz® demonstrated a significant increase in complete clearance rates of 45.6% compared to the control group in its Phase 3 trial for mild to moderate actinic keratosis (p<0.0003), establishing a strong foundation for market promotion.
- Efficacy Assessment: In the Full Analysis Set (FAS), 73.1% of patients showed lesion clearance 12 weeks post-treatment, indicating Ameluz®'s effectiveness in treating actinic keratosis, which may attract more attention from physicians and patients alike.
- Patient Satisfaction: 75.2% of patients rated the aesthetic appearance of their skin as
See More
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.
See More
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.
See More
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.
See More
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.
See More
