{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-015531","form_type":"8-K","ticker":"ABEO","cik":"0000318306","company_name":"ABEONA THERAPEUTICS INC.","filed_at":"2024-04-22T23:59:59+00:00","discovered_at":"2026-05-14T18:03:21.536926+00:00","generated_at":"2026-06-03T14:39:58.613122+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Abeona receives FDA Complete Response Letter for pz-cel BLA due to CMC deficiencies","bullets":["FDA CRL for pz-cel BLA cites additional CMC information needed; no clinical efficacy/safety deficiencies.","No new clinical trials or clinical data requested by FDA for approval.","Company expects to complete BLA resubmission with requested CMC data in Q3 2024.","PDUFA date of May 25, 2024 will be missed due to proposed timing of data submission."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-015531","json":"https://secwatch.observer/filing/0001493152-24-015531.json","markdown":"https://secwatch.observer/filing/0001493152-24-015531.md","text":"https://secwatch.observer/filing/0001493152-24-015531.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/318306/000149315224015531/0001493152-24-015531-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/318306/000149315224015531/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-03T14:39:58.613122+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"}