{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-056480","form_type":"8-K","ticker":"VBIO","cik":"0001787740","company_name":"Valion Bio, Inc.","filed_at":"2025-04-22T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.724084+00:00","generated_at":"2026-05-23T09:27:22.312648+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Tivic Health briefed White House and FDA on TLR5 candidates and ncVNS; positive interest noted","bullets":["On April 17, 2025, briefed White House senior leadership on Entolimod for acute radiation syndrome and need for advanced treatments.","Met with FDA to discuss expedited pathways for Entolimod, Entolasta (second-gen TLR5 agonist), and non-invasive cervical VNS technology.","Previous U.S. government funding from BARDA, NASA, DTRA, DoD, and Army for TLR5 program highlighted.","Positive interest in military/defense applications; FDA explored breakthrough device designations for ncVNS after clinical work.","CEO Jennifer Ernst expects continued discussions as programs progress toward potential FDA approval."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-056480","json":"https://secwatch.observer/filing/0000950170-25-056480.json","markdown":"https://secwatch.observer/filing/0000950170-25-056480.md","text":"https://secwatch.observer/filing/0000950170-25-056480.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1787740/000095017025056480/0000950170-25-056480-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1787740/000095017025056480/tivc-20250422.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T09:27:22.312648+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"}