BFRI Stock Catalyst: Biofrontera Announces Positive Phase 3 Results for Ameluz PDT in AKs Treatment

Biofrontera Inc. (Nasdaq: BFRI) announced on February 09, 2026, positive results from its Phase 3 clinical study evaluating Ameluz photodynamic therapy (PDT) for the treatment of actinic keratoses (AKs) on the extremities, neck, and trunk. The study involved 172 patients, with a 4:1 randomization to receive either Ameluz gel or vehicle gel.

45.6% of patients treated with Ameluz PDT achieved complete clearance of AKs compared to 16.7% with vehicle PDT. The per-protocol set (PPS) analysis showed 53.2% clearance for Ameluz PDT versus 22.2% for vehicle PDT. In the full analysis set (FAS), 73.1% of patients showed a response, while in the PPS, 80.3% responded. On the extremities, 38.5% (FAS) and 46.5% (PPS) of patients achieved clearance. On the neck and trunk, 74.1% (FAS) and 78.3% (PPS) of patients showed clearance. Overall, 75.2% of patients in the FAS and 70.9% in the PPS experienced at least one adverse event, with 86.3% of these events being mild or moderate.

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