{"schema_version":"secwatch.filing_event.v1","accession":"0000805928-25-000140","form_type":"8-K","ticker":"AXGN","cik":"0000805928","company_name":"Axogen, Inc.","filed_at":"2025-12-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:42.220399+00:00","generated_at":"2026-05-16T14:59:52.865284+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Axogen receives FDA approval of BLA for Avance nerve allograft under Accelerated Approval pathway","bullets":["FDA approved Biologics License Application for Avance (acellular nerve allograft) for sensory, mixed, motor nerve discontinuities in adults and pediatric patients 1 month+.","Indications for sensory gaps >25mm and mixed/motor gaps approved under Accelerated Approval pathway; continued approval depends on confirmatory studies.","Commercial launch of licensed Avance expected early Q2 2026; product remains available under current tissue framework until then.","CEO Michael Dale says approval strengthens regulatory footing and confirms Avance as safe, pure, potent therapeutic option."],"urls":{"canonical":"https://secwatch.observer/filing/0000805928-25-000140","json":"https://secwatch.observer/filing/0000805928-25-000140.json","markdown":"https://secwatch.observer/filing/0000805928-25-000140.md","text":"https://secwatch.observer/filing/0000805928-25-000140.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/805928/000080592825000140/0000805928-25-000140-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/805928/000080592825000140/axgn-20251203.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T14:59:52.865284+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"}