{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-064544","form_type":"8-K","ticker":"TOVX","cik":"0000894158","company_name":"Theriva Biologics, Inc.","filed_at":"2024-05-23T23:59:59+00:00","discovered_at":"2026-05-14T18:03:22.347097+00:00","generated_at":"2026-06-01T09:30:39.205079+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Theriva Biologics receives FDA Fast Track Designation for VCN-01 in metastatic pancreatic cancer","bullets":["FDA granted Fast Track Designation for VCN-01 combined with gemcitabine/nab-paclitaxel for metastatic pancreatic adenocarcinoma.","VCN-01 is being evaluated in the ongoing Phase 2b VIRAGE trial as first-line therapy for pancreatic ductal adenocarcinoma.","Enrollment in VIRAGE expected to complete in Q3 2024.","Previously, FDA granted orphan drug designation to VCN-01 for PDAC."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-064544","json":"https://secwatch.observer/filing/0001104659-24-064544.json","markdown":"https://secwatch.observer/filing/0001104659-24-064544.md","text":"https://secwatch.observer/filing/0001104659-24-064544.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/894158/000110465924064544/0001104659-24-064544-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/894158/000110465924064544/tm2415354d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T09:30:39.205079+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"}