{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-124523","form_type":"8-K","ticker":"TOVX","cik":"0000894158","company_name":"Theriva Biologics, Inc.","filed_at":"2025-12-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:42.518923+00:00","generated_at":"2026-05-16T12:12:44.028049+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"EMA provides positive Scientific Advice on Theriva's Phase 3 trial design for VCN-01 in metastatic PDAC","bullets":["EMA CHMP agreed on Phase 3 design for VCN-01 + gem/nab-paclitaxel vs SoC; primary endpoint overall survival.","CHMP agreed on repeated dosing in macrocycles, enabling >2 doses; recognized VIRAGE survival benefit.","Theriva plans End-of-Phase 2 meeting with FDA in H1 2026 to finalize multinational Phase 3 trial.","Cash runway into Q1 2027 ($15.5M at Nov 10, 2025) supports regulatory activities and partnering.","VCN-01 has Orphan Drug designation in EU/US, Fast Track in US, and Rare Pediatric Disease for retinoblastoma."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-124523","json":"https://secwatch.observer/filing/0001104659-25-124523.json","markdown":"https://secwatch.observer/filing/0001104659-25-124523.md","text":"https://secwatch.observer/filing/0001104659-25-124523.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/894158/000110465925124523/0001104659-25-124523-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/894158/000110465925124523/tm2534356d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T12:12:44.028049+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"}