{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-042775","form_type":"8-K","ticker":"ABEO","cik":"0000318306","company_name":"ABEONA THERAPEUTICS INC.","filed_at":"2024-10-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:10.694616+00:00","generated_at":"2026-05-30T09:27:07.921302+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Abeona Therapeutics resubmits BLA for pz-cel gene therapy for RDEB to FDA","bullets":["Resubmitted Biologics License Application (BLA) for pz-cel to FDA for recessive dystrophic epidermolysis bullosa (RDEB).","Resubmission addresses all Chemistry Manufacturing and Controls (CMC) items from April 2024 Complete Response Letter.","No new clinical trials or data requested; prior CRL had no deficiencies in safety or efficacy.","FDA expected to set new PDUFA target action date; review period is 2 or 6 months based on classification.","Pz-cel holds Regenerative Medicine Advanced Therapy, Breakthrough, Orphan, and Rare Pediatric Disease designations."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-042775","json":"https://secwatch.observer/filing/0001493152-24-042775.json","markdown":"https://secwatch.observer/filing/0001493152-24-042775.md","text":"https://secwatch.observer/filing/0001493152-24-042775.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/318306/000149315224042775/0001493152-24-042775-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/318306/000149315224042775/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T09:27:07.921302+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"}