- Ultra-thinly traded Biofrontera (BFRA +4.1%) is up an 8x surge in volume, albeit on turnover of only 12,700 shares, on the heels of preliminary data from a Phase 3 clinical trial evaluating conventional photodynamic therapy (PDT) with topical gel Ameluz (aminolevulinic acid hydrochloride) and the BF-RhodoLED lamp for the treatment of actinic keratoses on the extremities, trunk and neck.
- The study met the primary endpoint, showing the superiority of Ameluz to placebo as measured by average total lesion clearance. Specifically, 86% of lesions were cleared in the Ameluz cohort compared to 33% for the control arm (p<0.0001).
- The company plans to file marketing applications in the U.S. and Europe in Q3.