{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-24-064993","form_type":"8-K","ticker":"ATNM","cik":"0001388320","company_name":"Actinium Pharmaceuticals, Inc.","filed_at":"2024-08-05T23:59:59+00:00","discovered_at":"2026-05-14T18:03:12.867596+00:00","generated_at":"2026-05-31T13:02:50.668275+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA requires additional Phase 3 trial for Iomab-B; SIERRA alone not adequate for BLA filing","bullets":["SIERRA met primary endpoint (dCR) with p<0.0001, but FDA now demands overall survival benefit in randomized head-to-head trial.","New trial required: Iomab-B plus Flu/TBI vs cyclophosphamide plus Flu/TBI; no crossover allowed (vs 60% crossover in SIERRA).","FDA suggests patient population could include all adult AML; specifics to be discussed in requested meeting.","Actinium will seek a strategic partner for Iomab-B in U.S. after FDA interactions; focus shifts to Actimab-A, Iomab-ACT, preclinical.","Management disappointed but will work with FDA; SIERRA supportive evidence for future BLA filing."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-24-064993","json":"https://secwatch.observer/filing/0001213900-24-064993.json","markdown":"https://secwatch.observer/filing/0001213900-24-064993.md","text":"https://secwatch.observer/filing/0001213900-24-064993.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1388320/000121390024064993/0001213900-24-064993-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1388320/000121390024064993/ea0210560-8k_actinium.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T13:02:50.668275+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"}