{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-008557","form_type":"8-K","ticker":"PDSB","cik":"0001472091","company_name":"PDS Biotechnology Corp","filed_at":"2025-03-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.721374+00:00","generated_at":"2026-05-24T21:01:56.293079+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"PDS Biotech announces FDA clearance of IND for Versamune MUC1 + PDS01ADC to treat metastatic colorectal cancer","bullets":["FDA cleared IND for Versamune MUC1 (formerly PDS0103) + PDS01ADC to treat MUC1-positive unresectable metastatic colorectal carcinoma in failed prior treatment.","Phase 1/2 trial will be led by the National Cancer Institute under a CRADA with PDS Biotech.","MUC1 is over-expressed in colon, pancreatic, ovarian, breast, and NSCLC; study targets MSS mCRC, which accounts for 95% of mCRC patients.","U.S. Patent #12,201,685 covers methods of using Versamune platform and immunocytokines including PDS01ADC.","Company's primary focus remains on VERSATILE-003 Phase 3 trial in HPV16-positive head and neck squamous cell carcinoma."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-008557","json":"https://secwatch.observer/filing/0001140361-25-008557.json","markdown":"https://secwatch.observer/filing/0001140361-25-008557.md","text":"https://secwatch.observer/filing/0001140361-25-008557.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125008557/0001140361-25-008557-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125008557/ef20045415_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T21:01:56.293079+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"}