{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-003082","form_type":"8-K","ticker":"PDSB","cik":"0001472091","company_name":"PDS Biotechnology Corp","filed_at":"2025-02-05T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.720288+00:00","generated_at":"2026-05-27T02:32:48.564911+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"PDS Biotech Reaffirms Guidance to Initiate VERSATILE-003 Phase 3 Trial in Q1 2025","bullets":["FDA cleared amended trial design for VERSATILE-003 Phase 3 trial of Versamune HPV plus pembrolizumab in HPV16-positive R/M HNSCC.","First site initiation expected in Q1 2025; FDA comment window has passed and company on track.","Fast Track designation from FDA for the combination in recurrent/metastatic HNSCC.","Companion diagnostic to confirm HPV16-positive status will be used in patient screening.","Guidance reaffirmed on February 5, 2025 via press release and corporate presentation."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-003082","json":"https://secwatch.observer/filing/0001140361-25-003082.json","markdown":"https://secwatch.observer/filing/0001140361-25-003082.md","text":"https://secwatch.observer/filing/0001140361-25-003082.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125003082/0001140361-25-003082-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125003082/ef20042909_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud","generated_at":"2026-05-27T02:32:48.564911+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"}