Biofrontera's Ameluz New Drug Application Accepted by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 11 2026
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Should l Buy BFRI?
Biofrontera announced that the U.S. Food and Drug Administration has completed its filing review and accepted filing of the Company's supplemental New Drug Application for Ameluz topical gel used in combination with the RhodoLED red-light lamp series for the treatment of sBCC. The FDA identified no filing deficiencies and assigned a PDUFA target action date of September 28, 2026.
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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: 0.912
Low
3.00
Averages
6.00
High
9.00
Current: 0.912
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 Wins Patent Review Against Sun Pharma
- Patent Review Outcome: On February 23, 2026, the U.S. Patent Trial and Appeal Board ruled that all challenged claims of Sun Pharmaceutical Industries' '028 Patent are unpatentable, providing Biofrontera with legal support in the photodynamic therapy market.
- Litigation Background: Following Sun Pharma's infringement lawsuit against Biofrontera in June 2024, the company proactively challenged the patent's validity, leading to a favorable decision that strengthens its position.
- Future Development Focus: Biofrontera's CEO Hermann Luebbert stated that the company will continue to concentrate on clinical research and development in the PDT space, aiming to enhance treatment outcomes for clinicians and improve patients' quality of life.
- Product Commercialization: Biofrontera specializes in dermatological treatments, commercializing Ameluz® with the RhodoLED® lamp series for treating actinic keratosis, with future plans to expand into non-melanoma skin cancers and moderate-to-severe acne treatments.
See More
Biofrontera Completes Phase 1 Pharmacokinetics Study for Ameluz®
- Research Milestone: Biofrontera locked the database for its Phase 1 pharmacokinetics study evaluating Ameluz® on February 11, 2026, which assessed systemic exposure to 5-aminolevulinic acid (ALA) and its metabolite protoporphyrin IX (PpIX) under maximal use conditions, marking a significant advancement in the company's clinical program.
- Clinical Data Support: The study involved 17 patients and measured plasma concentrations of ALA and PpIX after applying three tubes of Ameluz® over a 240 cm² treatment area, with the data intended to support a supplemental New Drug Application (sNDA) to the FDA for label expansion.
- Label Expansion Plan: The sNDA, expected to be submitted in Q3 2026, aims to extend Ameluz®'s indication from a 60 cm² treatment area on the face and scalp to 240 cm² on other body parts, which, if approved, would significantly enhance Ameluz®'s market potential for treating extensive actinic keratosis.
- Market Opportunity: With approximately 58 million people affected by actinic keratosis in the U.S. in 2020, Biofrontera's expansion plans not only address this substantial market demand but also strengthen its competitive position in the photodynamic therapy sector.
See More
BIOFRONTERA INC ANTICIPATES SUPPLEMENTAL NDA FILING FOR EXTREMITY, NECK, AND TRUNK INDICATION IN Q3 2026
- Supplemental Indication: A new supplemental indication for the treatment of extremities, neck, and trunk is expected to be submitted in Q3 2026.
- Focus on Extremities: The indication aims to address specific medical needs related to extremities, neck, and trunk conditions.
See More
BIOFRONTERA INC. REPORTS COMPLETION OF DATABASE LOCK FOR PHASE 1 PHARMACOKINETICS STUDY OF AMELUZ® IN TREATING ACTINIC KERATOSES ON TRUNK AND EXTREMITIES
Announcement of Study: BioFrontier AI has announced a study focusing on the pharmacokinetics of a Phase 1 drug, specifically a formulation for Actinic Keratosis.
Target Condition: The study aims to evaluate the drug's effectiveness on trunk and extremities affected by Actinic Keratosis.
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 Wins Patent Review Against Sun Pharma
- Patent Review Outcome: On February 23, 2026, the U.S. Patent Trial and Appeal Board ruled that all challenged claims of Sun Pharmaceutical Industries' '028 Patent are unpatentable, providing Biofrontera with legal support in the photodynamic therapy market.
- Litigation Background: Following Sun Pharma's infringement lawsuit against Biofrontera in June 2024, the company proactively challenged the patent's validity, leading to a favorable decision that strengthens its position.
- Future Development Focus: Biofrontera's CEO Hermann Luebbert stated that the company will continue to concentrate on clinical research and development in the PDT space, aiming to enhance treatment outcomes for clinicians and improve patients' quality of life.
- Product Commercialization: Biofrontera specializes in dermatological treatments, commercializing Ameluz® with the RhodoLED® lamp series for treating actinic keratosis, with future plans to expand into non-melanoma skin cancers and moderate-to-severe acne treatments.
See More
Biofrontera Completes Phase 1 Pharmacokinetics Study for Ameluz®
- Research Milestone: Biofrontera locked the database for its Phase 1 pharmacokinetics study evaluating Ameluz® on February 11, 2026, which assessed systemic exposure to 5-aminolevulinic acid (ALA) and its metabolite protoporphyrin IX (PpIX) under maximal use conditions, marking a significant advancement in the company's clinical program.
- Clinical Data Support: The study involved 17 patients and measured plasma concentrations of ALA and PpIX after applying three tubes of Ameluz® over a 240 cm² treatment area, with the data intended to support a supplemental New Drug Application (sNDA) to the FDA for label expansion.
- Label Expansion Plan: The sNDA, expected to be submitted in Q3 2026, aims to extend Ameluz®'s indication from a 60 cm² treatment area on the face and scalp to 240 cm² on other body parts, which, if approved, would significantly enhance Ameluz®'s market potential for treating extensive actinic keratosis.
- Market Opportunity: With approximately 58 million people affected by actinic keratosis in the U.S. in 2020, Biofrontera's expansion plans not only address this substantial market demand but also strengthen its competitive position in the photodynamic therapy sector.
See More
BIOFRONTERA INC ANTICIPATES SUPPLEMENTAL NDA FILING FOR EXTREMITY, NECK, AND TRUNK INDICATION IN Q3 2026
- Supplemental Indication: A new supplemental indication for the treatment of extremities, neck, and trunk is expected to be submitted in Q3 2026.
- Focus on Extremities: The indication aims to address specific medical needs related to extremities, neck, and trunk conditions.
See More
BIOFRONTERA INC. REPORTS COMPLETION OF DATABASE LOCK FOR PHASE 1 PHARMACOKINETICS STUDY OF AMELUZ® IN TREATING ACTINIC KERATOSES ON TRUNK AND EXTREMITIES
Announcement of Study: BioFrontier AI has announced a study focusing on the pharmacokinetics of a Phase 1 drug, specifically a formulation for Actinic Keratosis.
Target Condition: The study aims to evaluate the drug's effectiveness on trunk and extremities affected by Actinic Keratosis.
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
