{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-000786","form_type":"8-K","ticker":"PDSB","cik":"0001472091","company_name":"PDS Biotechnology Corp","filed_at":"2026-01-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.142767+00:00","generated_at":"2026-05-16T11:03:09.646758+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"PDS Biotech Submits FDA Protocol Amendment for Phase 3 VERSATILE-003, PFS Endpoint for Accelerated Approval","bullets":["On January 9, 2026, PDS Biotech submitted a protocol amendment to the FDA for its Phase 3 VERSATILE-003 trial.","The amendment changes progression free survival (PFS) to a primary endpoint for earlier evaluation, potentially enabling accelerated approval of PDS0101.","Median overall survival remains the primary endpoint for full approval as originally recommended by FDA.","The amendment follows a constructive Type C meeting with the FDA in December 2025.","The amendment is supported by positive final results from VERSATILE-002 trial showing promising mOS and durable PFS."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-000786","json":"https://secwatch.observer/filing/0001140361-26-000786.json","markdown":"https://secwatch.observer/filing/0001140361-26-000786.md","text":"https://secwatch.observer/filing/0001140361-26-000786.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1472091/000114036126000786/0001140361-26-000786-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1472091/000114036126000786/ef20062601_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud","generated_at":"2026-05-16T11:03:09.646758+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"}