Biofrontera Inc. confirmed that the databases for its two most critical clinical studies were locked on January 5 2026, a milestone announced on January 8 2026. The first study is a Phase III trial of Ameluz® photodynamic therapy (PDT) for actinic keratosis (AK) on the extremities, neck, and trunk, while the second is a Phase II trial evaluating Ameluz for moderate‑to‑severe acne vulgaris.
The database lock enables the company to unblind the data and conduct the final statistical analysis, a prerequisite for regulatory submissions. Biofrontera expects the results from both studies to be available in February 2026. A positive outcome would allow the company to file a supplemental New Drug Application for AK on the extremities, neck, and trunk in summer 2026, and to present the acne data to the FDA in early Q3 2026 to inform a future Phase III program.
Financially, Biofrontera reported a Q3 2025 revenue of $6.99 million and a net loss of $6.6 million, down from $9.0 million in revenue and a $5.7 million net loss in Q3 2024. The revenue decline was driven by customers advancing purchases in Q3 2024 ahead of a planned price increase, illustrating a temporary headwind that the company has managed through pricing strategy adjustments.
CEO Prof. Hermann Luebbert highlighted the unmet need for effective AK and acne treatments, noting that antibiotic resistance and treatment burden are significant challenges. He emphasized that Ameluz’s in‑office PDT could improve patient compliance and offer a non‑antibiotic alternative, reinforcing the company’s strategic focus on expanding the drug’s therapeutic portfolio.
The database lock is a critical step toward expanding Ameluz beyond its current facial and scalp AK indications. Successful regulatory submissions could unlock new revenue streams and improve Biofrontera’s long‑term financial prospects, aligning with the company’s goal of broadening its market share in dermatology.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.