{"schema_version":"secwatch.filing_event.v1","accession":"0001641172-25-000207","form_type":"8-K","ticker":"IMNN","cik":"0000749647","company_name":"Imunon, Inc.","filed_at":"2025-03-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:06.264534+00:00","generated_at":"2026-05-24T07:31:19.919616+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":"IMUNON finalizes Phase 3 OVATION 3 trial design with FDA for IMNN-001 in advanced ovarian cancer","bullets":["FDA aligns on Phase 3 protocol for IMNN-001 plus NACT vs NACT alone in newly diagnosed advanced ovarian cancer (stage 3/4).","Primary endpoint is overall survival; secondary endpoints include surgical response, clinical response, time to second-line treatment.","Phase 2 data showed median OS of 46 months for IMNN-001+NACT vs 33 months for SoC, a 13-month improvement.","Company initiating trial sites; IMNN-001 manufactured at in-house facility in Huntsville, AL.","Conference call on March 25, 2025 at 2:00 p.m. ET to discuss Phase 3 OVATION 3 trial."],"urls":{"canonical":"https://secwatch.observer/filing/0001641172-25-000207","json":"https://secwatch.observer/filing/0001641172-25-000207.json","markdown":"https://secwatch.observer/filing/0001641172-25-000207.md","text":"https://secwatch.observer/filing/0001641172-25-000207.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/749647/000164117225000207/0001641172-25-000207-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/749647/000164117225000207/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T07:31:19.919616+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"}