Biofrontera Inc. Announces New Patent Protection on Ameluz® until 2043 and the Completion of Patient Enrollment in Phase 2b Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Moderate to Severe Acne Vulgaris
Patent Approval and Market Potential: Biofrontera has received patent approval for its revised formulation of Ameluz®, extending protection until December 2043, which aims to provide an effective treatment for moderate to severe acne without the side effects of systemic therapies. The U.S. acne treatment market is valued at $5.7 billion and is expected to grow due to increasing demand for advanced therapies.
Clinical Trial Progress: The company has successfully enrolled the final patient in a Phase 2b clinical trial assessing the safety and efficacy of Ameluz® for treating moderate to severe acne vulgaris, with results anticipated by Q3 2025, marking a significant step in expanding its indications beyond current approvals.
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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.
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.
BIOFRONTERA INC PLANS TO FILE SNDA WITH FDA IN Q3 2026
Company Overview: BioFrontier is a company focused on advancing artificial intelligence technologies in various sectors.
Recent Developments: The company has submitted its latest data and findings for Q3 2026, indicating progress in its research and development efforts.
BIOFRONTERA INC Reports 73.1% Lesion Clearance in FAS and 80.3% in PPS
Biofrontier AI: The article discusses advancements in AI technology, particularly in the field of bioinformatics.
Kleisen Clearance: It highlights the effectiveness of the Kleisen clearance method, showing a 73.1% improvement in certain applications.
Infas and PPS: The report mentions significant performance metrics, with Infas achieving a 73.1% clearance rate and PPS reaching 80.3%.
Overall Impact: The advancements in these technologies are expected to have a substantial impact on the healthcare and bioinformatics sectors.
BIOFRONTERA INC - AMELUZ PDT SHOWS 45.6% CLEARANCE RATE IN PHASE 3 TRIAL
- Study Overview: A Phase 3 study has reported a clearance rate of 45.6% for the treatment being evaluated.
- Significance of Results: The findings indicate a potential effectiveness of the treatment in the studied population.
BIOFRONTERA INC - PRIMARY ENDPOINT MET WITH FULL CLEARANCE RATE OF AK LESIONS
Primary Achievement: The BioFrontier AI has successfully achieved a primary endpoint.
Clearance Rate: The project boasts a complete clearance rate of Aklesiions.
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.
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.
BIOFRONTERA INC PLANS TO FILE SNDA WITH FDA IN Q3 2026
Company Overview: BioFrontier is a company focused on advancing artificial intelligence technologies in various sectors.
Recent Developments: The company has submitted its latest data and findings for Q3 2026, indicating progress in its research and development efforts.
BIOFRONTERA INC Reports 73.1% Lesion Clearance in FAS and 80.3% in PPS
Biofrontier AI: The article discusses advancements in AI technology, particularly in the field of bioinformatics.
Kleisen Clearance: It highlights the effectiveness of the Kleisen clearance method, showing a 73.1% improvement in certain applications.
Infas and PPS: The report mentions significant performance metrics, with Infas achieving a 73.1% clearance rate and PPS reaching 80.3%.
Overall Impact: The advancements in these technologies are expected to have a substantial impact on the healthcare and bioinformatics sectors.
BIOFRONTERA INC - AMELUZ PDT SHOWS 45.6% CLEARANCE RATE IN PHASE 3 TRIAL
- Study Overview: A Phase 3 study has reported a clearance rate of 45.6% for the treatment being evaluated.
- Significance of Results: The findings indicate a potential effectiveness of the treatment in the studied population.
BIOFRONTERA INC - PRIMARY ENDPOINT MET WITH FULL CLEARANCE RATE OF AK LESIONS
Primary Achievement: The BioFrontier AI has successfully achieved a primary endpoint.
Clearance Rate: The project boasts a complete clearance rate of Aklesiions.
