{"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","discovered_at":"2026-05-14T18:03:26.108070+00:00","generated_at":"2026-06-06T09:21:52.007469+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"FDA accepts Biofrontera sNDA to allow up to 3 tubes of Ameluz per treatment; PDUFA Oct 4, 2024","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-004964","json":"https://secwatch.observer/filing/0001493152-24-004964.json","markdown":"https://secwatch.observer/filing/0001493152-24-004964.md","text":"https://secwatch.observer/filing/0001493152-24-004964.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-06T09:21:52.007469+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}