---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-004964"
form_type: "8-K"
ticker: "BFRI"
cik: "0001858685"
company_name: "Biofrontera Inc."
filed_at: "2024-02-05T23:59:59+00:00"
generated_at: "2026-06-06T09:21:52.007469+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Biofrontera sNDA to allow up to 3 tubes of Ameluz per treatment; PDUFA Oct 4, 2024

## Summary
- FDA completed filing review; target action date October 4, 2024 for Ameluz sNDA to increase max dosage from 1 to 3 tubes per treatment.
- sNDA supported by two Phase 1 safety studies in 32 and 100 patients; systemic and application site AEs similar to 1-tube use.
- Estimated 13M AK treatments annually in US; approval could increase Ameluz utilization by enabling single-visit treatment of larger areas.
- CEO Hermann Luebbert stated potential for more convenient treatment and increased US use if approved.

## SEC filing metadata
- accession: 0001493152-24-004964
- form_type: 8-K
- ticker: BFRI
- cik: 0001858685
- company_name: Biofrontera Inc.
- filed_at: 2024-02-05T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1858685/000149315224004964/0001493152-24-004964-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1858685/000149315224004964/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-004964
- JSON: https://secwatch.observer/filing/0001493152-24-004964.json
- Plain text: https://secwatch.observer/filing/0001493152-24-004964.txt

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