---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-043187"
form_type: "8-K"
ticker: "BFRI"
cik: "0001858685"
company_name: "Biofrontera Inc."
filed_at: "2024-10-31T23:59:59+00:00"
generated_at: "2026-05-30T07:39:45.379026+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Biofrontera reports Phase 3 sBCC study success; Ameluz-PDT primary endpoint met p<0.0001

## Summary
- Primary endpoint: 65.5% complete clearance vs 4.8% placebo (p<0.0001); histological clearance 75.9% vs 19.0%.
- Total clearance of all sBCC lesions: 64.1% vs 4.8% (p<0.0001); clinical clearance 83.4% vs 21.4%.
- FDA dossier submission expected around end of Q2/early Q3 2025 after 12-month follow-up ends Dec 2024.
- Study enrolled 187 patients; double-blind, randomized, placebo-controlled, multi-center design.
- BCC is most common skin cancer in US (~3.6M cases/year); sBCC is a subset with limited non-invasive options.

## SEC filing metadata
- accession: 0001493152-24-043187
- form_type: 8-K
- ticker: BFRI
- cik: 0001858685
- company_name: Biofrontera Inc.
- filed_at: 2024-10-31T23:59:59+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/1858685/000149315224043187/0001493152-24-043187-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1858685/000149315224043187/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-043187
- JSON: https://secwatch.observer/filing/0001493152-24-043187.json
- Plain text: https://secwatch.observer/filing/0001493152-24-043187.txt

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