---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-005717"
form_type: "8-K"
ticker: "BFRI"
cik: "0001858685"
company_name: "Biofrontera Inc."
filed_at: "2026-02-09T23:59:59+00:00"
generated_at: "2026-05-16T03:56:23.102706+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Biofrontera Phase 3 Ameluz® PDT meets primary endpoint for AK on extremities/neck/trunk

## Summary
- Complete clearance 45.6% (Ameluz®) vs 16.7% (vehicle), p<0.0003 in FAS.
- Per protocol set complete clearance 53.2% vs 22.2% (p<0.001).
- Study enrolled 172 patients randomized 4:1; lesion clearance rate 73.1% (FAS).
- Cosmetic outcomes: 75.2% rated 'good/very good'; 86.3% would choose PDT again.
- sNDA submission to FDA planned for Q3 2026 based on these positive results.

## SEC filing metadata
- accession: 0001493152-26-005717
- form_type: 8-K
- ticker: BFRI
- cik: 0001858685
- company_name: Biofrontera Inc.
- filed_at: 2026-02-09T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1858685/000149315226005717/0001493152-26-005717-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1858685/000149315226005717/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-005717
- JSON: https://secwatch.observer/filing/0001493152-26-005717.json
- Plain text: https://secwatch.observer/filing/0001493152-26-005717.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.