{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-24-035211","form_type":"8-K","ticker":"PDSB","cik":"0001472091","company_name":"PDS Biotechnology Corp","filed_at":"2024-08-01T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.150903+00:00","generated_at":"2026-05-31T13:45:48.014027+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"PDS Biotech aligns with FDA on Phase 3 VERSATILE-003 trial for HPV16-positive HNSCC; initiation in Q4 2024","bullets":["Received official FDA minutes supporting Phase 3 trial of Versamune HPV + pembrolizumab for first-line recurrent/metastatic HPV16-positive HNSCC.","FDA agreed to separate PDS01ADC dose optimization to avoid delay; VERSATILE-003 proceeds as a 2-arm double combination registrational trial.","Phase 3 VERSATILE-003 trial to begin enrollment in Q4 2024; primary endpoint is overall survival.","Versamune HPV + pembrolizumab combination holds FDA Fast Track designation for this indication.","Corporate presentation updated; management cites matured VERSATILE-002 survival data supporting revised statistical endpoints."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-24-035211","json":"https://secwatch.observer/filing/0001140361-24-035211.json","markdown":"https://secwatch.observer/filing/0001140361-24-035211.md","text":"https://secwatch.observer/filing/0001140361-24-035211.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1472091/000114036124035211/0001140361-24-035211-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1472091/000114036124035211/ef20033424_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T13:45:48.014027+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"}