{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-033051","form_type":"8-K","ticker":"TOVX","cik":"0000894158","company_name":"Theriva Biologics, Inc.","filed_at":"2026-03-23T23:59:59+00:00","discovered_at":"2026-05-14T18:02:37.972691+00:00","generated_at":"2026-05-15T09:26:25.270883+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Theriva Biologics obtains FDA agreement on Phase 3 trial design for VCN-01 in metastatic PDAC","bullets":["FDA provided general agreement on proposed Phase 3 trial design for VCN-01 plus gemcitabine/nab-paclitaxel.","Phase 3 trial will track successful VIRAGE Phase 2 design with repeat dosing and adaptive elements.","FDA agreed on primary endpoint (OS), key secondary endpoints, inclusion/exclusion criteria, and dosing schedule.","Consistent with prior EMA advice; company to finalize protocol and pursue funding or partnerships.","VIRAGE Phase 2 met primary endpoints; improved OS, PFS, DoR for VCN-01 plus SoC vs SoC alone in metastatic PDAC."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-033051","json":"https://secwatch.observer/filing/0001104659-26-033051.json","markdown":"https://secwatch.observer/filing/0001104659-26-033051.md","text":"https://secwatch.observer/filing/0001104659-26-033051.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/894158/000110465926033051/0001104659-26-033051-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/894158/000110465926033051/tm269559d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T09:26:25.270883+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"}