BFRI News & Events

Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, commented "We are very pleased with our fourth quarter performance which was driven by strong execution across the business, continued growth of Ameluz PDT and the pricing adjustment introduced in December. Customer adoption and engagement remained strong throughout the quarter, supporting record quarterly revenue performance, validating our strategic approach and setting us up for even stronger momentum throughout 2026."

Biofrontera announced the successful database lock of two clinical studies evaluating Ameluz PDT, marking an important milestone ahead of several anticipated data and regulatory events in 2026. The databases for the treatment phase of the Company's Phase 3 clinical study evaluating Ameluz PDT for the treatment of actinic keratosis on the extremities, neck and trunk as well as its Phase 2 clinical study evaluating the treatment of moderate to severe acne vulgaris were successfully locked on January 5, 2026. All data from participants that is collected throughout each study is captured in a specific database. Locking the database enables unblinding and statistical analysis of the study results in accordance with the pre-specified study endpoints. Biofrontera expects data for both studies to be available in February of this year.

Biofrontera announced the completion of the transfer of the FDA approvals for Ameluz and the RhodoLED Lamp Series, including the NDA and the Investigational New Drug Application, IND, to Biofrontera. In addition, the Company has completed all necessary filings to transfer all US and some international intellectual property associated with Ameluz and the RhodoLED Lamp Series, including 11 granted US patents, 10 US patent applications, and 19 patent filings or registered designs outside of the US. The registration of the assignment to Biofrontera of all associated trademarks has also been initiated. These asset transfers were secured, in part, by an $11.0 million investment recently reported by the Company.

Biofrontera Inc. files to sell 4M shares of common stock for holders