{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-22-030288","form_type":"8-K","ticker":"ABEO","cik":"0000318306","company_name":"ABEONA THERAPEUTICS INC.","filed_at":"2022-11-03T23:59:59+00:00","discovered_at":"2026-05-14T18:03:53.146026+00:00","generated_at":"2026-06-22T10:03:05.168287+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Abeona Phase 3 VIITAL study of EB-101 meets co-primary endpoints; BLA submission planned Q2 2023","bullets":["81.4% of treated wounds achieved ≥50% healing vs 16.3% controls (p<0.0001).","Pain reduction co-primary endpoint met: mean reduction 3.07 treated vs 0.90 control (p=0.0002).","No serious treatment-related adverse events; consistent with past safety profile.","BLA submission to FDA for EB-101 in RDEB targeted for Q2 2023.","EB-101 has Orphan Drug and Rare Pediatric Disease designations, may qualify for Priority Review Voucher."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-22-030288","json":"https://secwatch.observer/filing/0001493152-22-030288.json","markdown":"https://secwatch.observer/filing/0001493152-22-030288.md","text":"https://secwatch.observer/filing/0001493152-22-030288.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/318306/000149315222030288/0001493152-22-030288-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/318306/000149315222030288/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-22T10:03:05.168287+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"}