MedPath

Biofrontera

🇺🇸United States
Ownership
-
Employees
85
Market Cap
-
Website
Introduction

Biofrontera, Inc. is a biopharmaceutical company, which engages in the commercialization of pharmaceutical products. It specializes in the treatment of dermatological conditions, caused primarily by exposure to sunlight that results in sun damage to the skin. The company is focused on the treatment of actinic keratosis and markets a topical antibiotic for treatment of impetigo. Its products include Ameluz and Xepi, its two prescription drugs, and BF-RhodoLED, a lamp used with Ameluz, for the lesion-directed and field-directed treatment of actinic keratosis of mild-to-moderate severity on the face and scalp. The company was founded on March 3, 2015 and is headquartered in Woburn, MA.

Clinical Trials

0

Active:0
Completed:0

Trial Phases

0 Phases

Drug Approvals

2

FDA:2

Drug Approvals

AMELUZ

Approval Date
Mar 18, 2024
FDA

Xepi

Approval Date
Sep 25, 2023
FDA

Clinical Trials

No trials found

News

Biofrontera Acquires Full US Rights to Ameluz and RhodoLED, Secures $11M Funding

Biofrontera Inc. acquired all US assets for Ameluz® and RhodoLED® from Biofrontera AG, including the New Drug Application and associated patents.

Biofrontera Inc. Negotiates Strategic Partnership Changes with German Parent Company

Biofrontera Inc. and Biofrontera AG are negotiating potential company combination or license agreement adjustments that could transfer rights and reduce transfer pricing for US products.

Biofrontera's Ameluz Secures Patent Extension to 2043, Targets $5.7B Acne Market

Biofrontera Inc. has secured FDA approval for a reformulated Ameluz nanoemulsion gel, extending patent protection until 2043 and allowing up to three tubes per treatment, potentially increasing revenue through larger average sales.

Biofrontera's Ameluz-PDT Shows Promise in Phase 3 Trial for Superficial Basal Cell Carcinoma

Biofrontera's Phase 3 trial of Ameluz-PDT for superficial basal cell carcinoma (sBCC) has reached a crucial milestone with all patients completing the 1-year follow-up.

Ameluz-PDT Demonstrates High Lesion Clearance in Superficial Basal Cell Carcinoma Phase 3 Trial

Ameluz-PDT significantly improved target lesion clearance in superficial basal cell carcinoma (sBCC) compared to placebo-PDT in a phase 3 trial.

Biofrontera's Ameluz Demonstrates High Efficacy in Phase III sBCC Trial

Biofrontera's Ameluz-PDT therapy met the primary endpoint, showing 65.5% success in complete clearance of superficial basal cell carcinoma (sBCC) lesions, compared to 4.8% with placebo.

Biofrontera's Ameluz Demonstrates Success in Phase III sBCC Trial, Stock Surges

Biofrontera's Ameluz-PDT therapy met the primary endpoint in a Phase III trial for superficial basal cell carcinoma (sBCC), showing significant clinical and histological clearance.

Ameluz Demonstrates High Efficacy in Phase 3 Trial for Superficial Basal Cell Carcinoma

Biofrontera's Ameluz-PDT achieved a 65.5% success rate in complete clearance of sBCC lesions, significantly outperforming placebo at 4.8%.

Biofrontera Announces Database Lock for Phase 3 sBCC Study of Ameluz®-PDT

Biofrontera has locked the database for its Phase 3 trial evaluating Ameluz®-PDT for superficial basal cell carcinoma (sBCC) treatment.

FDA Approves Expanded Use of Biofrontera's Ameluz for Actinic Keratosis Treatment

The FDA has approved a supplemental New Drug Application (sNDA) for Biofrontera's Ameluz, allowing up to three tubes per actinic keratosis treatment.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.