{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-125774","form_type":"8-K","ticker":"TOVX","cik":"0000894158","company_name":"Theriva Biologics, Inc.","filed_at":"2024-12-05T23:59:59+00:00","discovered_at":"2026-05-14T18:03:11.294387+00:00","generated_at":"2026-05-29T07:54:10.486616+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":"Theriva Biologics receives FDA guidance for Phase 3 study of VCN-01 in metastatic pancreatic cancer","bullets":["FDA advised stand-alone Phase 3 study of VCN-01 with gemcitabine/nab-paclitaxel; VIRAGE Phase 2b should not be expanded into Phase 3.","FDA generally agreed with Theriva's proposed Phase 3 design; no additional chemotherapy needed for PDAC.","VIRAGE Phase 2b enrollment completed; final patient follow-up is underway.","Additional FDA meeting planned after VIRAGE completion to discuss Phase 3 protocol details."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-125774","json":"https://secwatch.observer/filing/0001104659-24-125774.json","markdown":"https://secwatch.observer/filing/0001104659-24-125774.md","text":"https://secwatch.observer/filing/0001104659-24-125774.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/894158/000110465924125774/0001104659-24-125774-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/894158/000110465924125774/tm2430229d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T07:54:10.486616+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"}