{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-079310","form_type":"8-K","ticker":"MRKR","cik":"0001094038","company_name":"Marker Therapeutics, Inc.","filed_at":"2023-07-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.126509+00:00","generated_at":"2026-06-13T10:27:38.564766+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Marker Therapeutics' MT-401 receives EMA Orphan Drug Designation for AML","bullets":["EMA granted Orphan Drug Designation for zedenoleucel (MT-401) for acute myeloid leukemia (AML).","MT-401 is a non-genetically modified multiTAA-specific T cell therapy targeting four AML-associated antigens.","Phase 2 trial ongoing for relapsed AML after allogeneic HSCT; FDA also granted orphan designation in 2020.","Benefits include 10-year EU market exclusivity post-approval, reduced regulatory fees, and scientific advice.","Relapsed AML after HSCT has median survival <1 year, underscoring the need for new therapies."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-079310","json":"https://secwatch.observer/filing/0001104659-23-079310.json","markdown":"https://secwatch.observer/filing/0001104659-23-079310.md","text":"https://secwatch.observer/filing/0001104659-23-079310.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1094038/000110465923079310/0001104659-23-079310-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1094038/000110465923079310/tm2320895d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T10:27:38.564766+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"}