{"schema_version":"secwatch.filing_event.v1","accession":"0001641172-25-006548","form_type":"8-K","ticker":"ABEO","cik":"0000318306","company_name":"ABEONA THERAPEUTICS INC.","filed_at":"2025-04-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:50.927457+00:00","generated_at":"2026-05-23T04:19:30.026696+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA approves Abeona's ZEVASKYN, first cell-based gene therapy for RDEB","bullets":["81% of ZEVASKYN-treated wounds achieved ≥50% healing at 6 months vs 16% control (P<0.0001) in Phase 3 VIITAL study.","Rare Pediatric Disease Priority Review Voucher granted; company plans to monetize the PRV.","ZEVASKYN available through Qualified Treatment Centers starting 3Q 2025; Abeona Assist support program launched.","CEO cites pivotal moment for RDEB community; single surgical application aims for long-term wound healing and pain reduction."],"urls":{"canonical":"https://secwatch.observer/filing/0001641172-25-006548","json":"https://secwatch.observer/filing/0001641172-25-006548.json","markdown":"https://secwatch.observer/filing/0001641172-25-006548.md","text":"https://secwatch.observer/filing/0001641172-25-006548.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/318306/000164117225006548/0001641172-25-006548-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/318306/000164117225006548/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T04:19:30.026696+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"}