{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-108958","form_type":"8-K","ticker":"TOVX","cik":"0000894158","company_name":"Theriva Biologics, Inc.","filed_at":"2024-10-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:11.293740+00:00","generated_at":"2026-05-30T14:14:32.285423+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":"European Commission grants orphan designation to VCN-01 for retinoblastoma","bullets":["Orphan medicinal product designation granted by European Commission for VCN-01 oncolytic adenovirus to treat retinoblastoma.","FDA previously granted orphan drug and rare pediatric disease designations for same indication.","Designation provides 10-year EU market exclusivity post-approval, protocol assistance, and fee reductions.","Phase 1 trial in pediatric refractory retinoblastoma showed encouraging safety/activity with intravitreal VCN-01.","Company working with physicians and regulators on VCN-01 as adjunct to chemotherapy."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-108958","json":"https://secwatch.observer/filing/0001104659-24-108958.json","markdown":"https://secwatch.observer/filing/0001104659-24-108958.md","text":"https://secwatch.observer/filing/0001104659-24-108958.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/894158/000110465924108958/0001104659-24-108958-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/894158/000110465924108958/tm2426230d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T14:14:32.285423+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"}