(RTTNews) - Biofrontera Inc. (BFRI), Monday announced positive and statistically significant top-line results from its Phase 3 clinical trial, evaluating Ameluz PDT with the red-light LEDplatform for the treatment of mild to moderate actinic keratoses on the extremities, neck, and trunk.
Despite these positive findings, Biofrontera's stock is moving down 8.66 percent, to $0.75 on the Nasdaq. The stock opened at $0.7 and has traded as far as $0.96 in today's session.
The multicenter, randomized, double-blind, vehicle-controlled study met its primary endpoint and showed highly statistically significant superiority for Ameluz vs. vehicle gel.
In the Full Analysis Set, complete clearance was achieved in 45.6 percent of patients treated with Ameluz PDT, compared with 16.7 percent of patients treated with vehicle PDT.
Additionally, Ameluz PDT demonstrated favorable cosmetic outcomes and high patient satisfaction.
Based on this data, Biofrontera plans to submit a supplemental New Drug Application to the U.S. Food and Drug Administration in the third quarter of 2026.
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