Biofrontera Reports Positive Phase 3 Results for Ameluz® PDT, Plans sNDA Submission

summarizeSummary

Biofrontera Inc. reported positive Phase 3 clinical trial results for Ameluz® PDT, meeting its primary endpoint with high statistical significance and indicating a significant expansion of its potential market. The company plans to submit an sNDA in Q3 2026.

check_boxKey Events

• Positive Phase 3 Clinical Trial Results

  Biofrontera Inc. announced positive top-line results from its Phase 3 study of Ameluz® PDT for actinic keratoses on the extremities, neck, and trunk.

• Met Primary Endpoint with Statistical Significance

  The study met its primary endpoint, showing highly statistically significant superiority for Ameluz® PDT versus vehicle gel (p<0.0003) in achieving complete clearance of all treated AK lesions.

• Expanded Market Potential

  These data support Ameluz®'s potential to treat broader, high-burden AK fields beyond the face and scalp, significantly expanding its addressable market.

• Planned sNDA Submission

  Based on these positive results, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the U.S. FDA in the third quarter of 2026.

auto_awesomeAnalysis

Biofrontera Inc. announced highly positive Phase 3 clinical trial results for its Ameluz® PDT treatment, demonstrating statistically significant superiority over vehicle gel for actinic keratoses on the extremities, neck, and trunk. This successful trial expands the potential addressable market for Ameluz® beyond its current indication for the face and scalp, which is a critical development for the company. The planned submission of a supplemental New Drug Application (sNDA) in Q3 2026, if approved, could significantly boost revenue and market position. This positive news follows a recent Nasdaq delisting notice, providing a potential catalyst to address compliance issues and build on the preliminary record revenues reported earlier this year.