Biofrontera (BFRX) Reports Ameluz PDT Phase 3 Success in Actinic Keratoses

Biofrontera (BFRX) announced positive top-line results from its Phase 3 trial of Ameluz PDT, a treatment for actinic keratoses, showing statistically significant improvement in clearance rates and reduced treatment duration. The trial met primary endpoints, with 70% of patients achieving complete lesion clearance at week 12 versus 40% in the control group. The company plans to submit a New Drug Application in Q1 2026, with potential approval timing dependent on review pace.