{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-028528","form_type":"8-K","ticker":"MBRX","cik":"0001659617","company_name":"Moleculin Biotech, Inc.","filed_at":"2025-09-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.583495+00:00","generated_at":"2026-05-17T07:37:15.411028+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Moleculin enrolls first EU patients in pivotal Phase 3 MIRACLE trial for R/R AML","bullets":["First two subjects enrolled, one treated in Spain; active sites in US, Spain, Ukraine, Georgia, Romania.","Goal to recruit 45 subjects for Part A unblinding by end of 2025; initial data readout in 2H 2025.","Phase 2B/3 adaptive design with Annamycin+cytarabine vs placebo; FDA Fast Track and Orphan Drug designations.","Part A randomizes 1:1:1 to HiDAC+placebo, 190 or 230 mg/m² Annamycin; Part B adds ~220 subjects.","EMA approval conditional on nonclinical GLP results before Part B."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-028528","json":"https://secwatch.observer/filing/0001437749-25-028528.json","markdown":"https://secwatch.observer/filing/0001437749-25-028528.md","text":"https://secwatch.observer/filing/0001437749-25-028528.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1659617/000143774925028528/0001437749-25-028528-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1659617/000143774925028528/mbrx20250905_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T07:37:15.411028+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"}