BFRI News & Events

Biofrontera announced that on February 23, 2026, the U.S. Patent Trial and Appeal Board issued a Final Written Decision finding all challenged claims of Sun Pharmaceutical Industries, Inc.'s U.S. Patent No. 11,697,028 to be unpatentable. As previously disclosed in Biofrontera's filings with the Securities and Exchange Commission, in June 2024, Sun Pharma initiated proceedings against Biofrontera and certain of its affiliates in the U.S. District Court for the District of Massachusetts and the International Trade Commission alleging infringement of the '028 Patent and a related patent, U.S. Patent No. 11,446,512. In response to these proceedings, Biofrontera challenged the validity of Sun Pharma's asserted claims by filing petitions for Inter Partes Review with the Board. The Board has now agreed with Biofrontera on all challenged claims of the '028 Patent. Sun Pharma has the right to request a review of the decision or appeal it to the United States Court of Appeals for the Federal Circuit. The decision does not affect the petition filed by the Company relating to the '512 patent, which was denied review by the Patent Office on administrative, rather than substantive, grounds. "Biofrontera is pleased with the Board's Final Written Decision.," commented Hermann Luebbert, CEO and Chairman of Biofrontera. "We remain focused on clinical research and development in the PDT space to better serve clinicians and improve their patients' lives."

Biofrontera announced that the U.S. Food and Drug Administration has completed its filing review and accepted filing of the Company's supplemental New Drug Application for Ameluz topical gel used in combination with the RhodoLED red-light lamp series for the treatment of sBCC. The FDA identified no filing deficiencies and assigned a PDUFA target action date of September 28, 2026.

Biofrontera announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz PDT with the red-light LED, or RhodoLED, platform for the treatment of mild to moderate actinic keratoses on the extremities, neck, and trunk. Ameluz PDT demonstrated highly statistically significant superiority over vehicle PDT for the primary endpoint of "subject complete clearance rate," with complete clearance achieved in 45.6% of patients treated with Ameluz PDT compared with 16.7% of patients treated with vehicle gel. "These results represent a critical milestone in our clinical program," said Hermann Luebbert, CEO and chairman of Biofrontera. "These data support Ameluz's potential to treat broader, high-burden AK fields beyond the face and scalp, significantly expanding its potential clinical use across multiple sun-exposed body areas, underscoring the potential to expand Ameluz's addressable market beyond the face and scalp. If approved, this label expansion would provide meaningful benefit to patients with actinic keratoses on the extremities, neck, and trunk and represent an important step forward in advancing our vision to establish leadership in photodynamic therapy."