Biofrontera's Ameluz® sNDA Accepted by FDA for sBCC Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5 days ago
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Should l Buy BFRI?
Source: Newsfilter
- FDA Acceptance Milestone: Biofrontera's supplemental New Drug Application (sNDA) for Ameluz® has been accepted by the FDA, with a target action date set for September 28, 2026; if approved, Ameluz® will be the first and only PDT photosensitizer indicated for superficial Basal Cell Carcinoma (sBCC) in the U.S., significantly expanding its clinical utility.
- Significant Market Opportunity: With approximately 3.6 million cases of basal cell carcinoma diagnosed annually in the U.S., and 10-25% being superficial subtype, the non-invasive treatment option provided by Ameluz® is expected to meet patient demand for safer alternatives, potentially increasing market share substantially.
- Technological Edge: The combination of Ameluz® with the RhodoLED® red-light lamp utilizes nanoemulsion technology to penetrate deeper into skin layers, offering more effective treatment compared to traditional green and blue wavelengths, thereby validating Biofrontera's technological prowess in photodynamic therapy.
- Strategic Growth Focus: CEO Dr. Hermann Luebbert emphasized that the FDA's acknowledgment of no filing deficiencies reflects the strength of their data package, marking a strategic expansion in dermatology aimed at addressing significant unmet medical needs through innovative treatment solutions.
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Analyst Views on BFRI
Wall Street analysts forecast BFRI stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.790
Low
3.00
Averages
6.00
High
9.00
Current: 0.790
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's Ameluz® sNDA Accepted by FDA for sBCC Treatment
- FDA Acceptance Milestone: Biofrontera's supplemental New Drug Application (sNDA) for Ameluz® has been accepted by the FDA, with a target action date set for September 28, 2026; if approved, Ameluz® will be the first and only PDT photosensitizer indicated for superficial Basal Cell Carcinoma (sBCC) in the U.S., significantly expanding its clinical utility.
- Significant Market Opportunity: With approximately 3.6 million cases of basal cell carcinoma diagnosed annually in the U.S., and 10-25% being superficial subtype, the non-invasive treatment option provided by Ameluz® is expected to meet patient demand for safer alternatives, potentially increasing market share substantially.
- Technological Edge: The combination of Ameluz® with the RhodoLED® red-light lamp utilizes nanoemulsion technology to penetrate deeper into skin layers, offering more effective treatment compared to traditional green and blue wavelengths, thereby validating Biofrontera's technological prowess in photodynamic therapy.
- Strategic Growth Focus: CEO Dr. Hermann Luebbert emphasized that the FDA's acknowledgment of no filing deficiencies reflects the strength of their data package, marking a strategic expansion in dermatology aimed at addressing significant unmet medical needs through innovative treatment solutions.
See More
BIOFRONTERA INC - FDA Establishes PDUFA Deadline for September 28, 2026
- Announcement of Date: The BioFrontier AI has set a date for the upcoming event on September 28, 2026.
- Event Significance: This date marks a significant milestone for the organization and its initiatives in the field of artificial intelligence.
See More
BIOFRONTERA CONFIRMS FDA ACCEPTANCE OF SUPPLEMENTAL NEW DRUG APPLICATION FOR AMELUZ® PDT IN TREATING SUPERFICIAL BASAL CELL CARCINOMA
Announcement of FDA Filing: Biofronterra has announced the acceptance of its supplemental new drug application by the FDA.
Drug Focus: The application is specifically for Ameluz® PDT, which is intended for the treatment of superficial basal cell carcinoma.
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
Biofrontera's Ameluz® sNDA Accepted by FDA for sBCC Treatment
- FDA Acceptance Milestone: Biofrontera's supplemental New Drug Application (sNDA) for Ameluz® has been accepted by the FDA, with a target action date set for September 28, 2026; if approved, Ameluz® will be the first and only PDT photosensitizer indicated for superficial Basal Cell Carcinoma (sBCC) in the U.S., significantly expanding its clinical utility.
- Significant Market Opportunity: With approximately 3.6 million cases of basal cell carcinoma diagnosed annually in the U.S., and 10-25% being superficial subtype, the non-invasive treatment option provided by Ameluz® is expected to meet patient demand for safer alternatives, potentially increasing market share substantially.
- Technological Edge: The combination of Ameluz® with the RhodoLED® red-light lamp utilizes nanoemulsion technology to penetrate deeper into skin layers, offering more effective treatment compared to traditional green and blue wavelengths, thereby validating Biofrontera's technological prowess in photodynamic therapy.
- Strategic Growth Focus: CEO Dr. Hermann Luebbert emphasized that the FDA's acknowledgment of no filing deficiencies reflects the strength of their data package, marking a strategic expansion in dermatology aimed at addressing significant unmet medical needs through innovative treatment solutions.
See More
BIOFRONTERA INC - FDA Establishes PDUFA Deadline for September 28, 2026
- Announcement of Date: The BioFrontier AI has set a date for the upcoming event on September 28, 2026.
- Event Significance: This date marks a significant milestone for the organization and its initiatives in the field of artificial intelligence.
See More
BIOFRONTERA CONFIRMS FDA ACCEPTANCE OF SUPPLEMENTAL NEW DRUG APPLICATION FOR AMELUZ® PDT IN TREATING SUPERFICIAL BASAL CELL CARCINOMA
Announcement of FDA Filing: Biofronterra has announced the acceptance of its supplemental new drug application by the FDA.
Drug Focus: The application is specifically for Ameluz® PDT, which is intended for the treatment of superficial basal cell carcinoma.
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
