Biofrontera Transfers Of Ameluz, RhodoLED New Drug Applications, Investigational New Drug Applications; Completes Requirements For Transfer Of All U.S., Some Global Intellectual Property Associated With Ameluz And RhodoLED

Benzinga · 1d ago

Biofrontera Inc. (Nasdaq: BFRI) ("Biofrontera" or the "Company"), a leader in photodynamic therapy (PDT) development and commercialization, today 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.

With the NDA and IND transfers effective as of December 17, 2025, Biofrontera now assumes full control of the Ameluz® NDA and IND, enabling the Company to manage ongoing and future clinical development activities independently, and to take full responsibility for all aspects of manufacturing and marketing Ameluz® and the RhodoLED® lamps in the US. The patent and trademark transfers further strengthen Biofrontera's intellectual property portfolio and market position in the US.