{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-25-054961","form_type":"8-K","ticker":"CERO","cik":"0001870404","company_name":"CERO THERAPEUTICS HOLDINGS, INC.","filed_at":"2025-06-17T23:59:59+00:00","discovered_at":"2026-05-14T18:02:50.308492+00:00","generated_at":"2026-05-19T05:13:09.170868+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"FDA grants Orphan Drug Designation to CERo's CER-1236 for AML treatment","bullets":["FDA Orphan Drug Designation granted to CER-1236 for acute myeloid leukemia (AML).","CER-1236 is an engineered T cell therapy leveraging phagocytic mechanisms; currently in Phase 1 trial.","ODD qualifies CERo for 7-year marketing exclusivity, FDA trial assistance, and fee exemptions.","AML is a life-threatening condition affecting ≤200,000 US patients annually."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-054961","json":"https://secwatch.observer/filing/0001213900-25-054961.json","markdown":"https://secwatch.observer/filing/0001213900-25-054961.md","text":"https://secwatch.observer/filing/0001213900-25-054961.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1870404/000121390025054961/0001213900-25-054961-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1870404/000121390025054961/ea0245971-8k_cero.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-19T05:13:09.170868+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"}