{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-078079","form_type":"8-K","ticker":"CADL","cik":"0001841387","company_name":"Candel Therapeutics, Inc.","filed_at":"2025-05-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:50.078421+00:00","generated_at":"2026-05-20T08:36:24.419386+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA grants RMAT designation to Candel's CAN-2409 for prostate cancer; phase 3 met endpoint","bullets":["RMAT designation for CAN-2409 (aglatimagene besadenovec) in newly diagnosed localized intermediate-to-high-risk prostate cancer.","Phase 3 trial met primary endpoint: 30% risk reduction in disease-free survival (HR 0.70; p=0.0155) vs placebo.","CAN-2409 improved prostate-specific DFS (38% risk reduction; p=0.0046) and pathological complete response (80.4% vs 63.6%; p=0.0015).","Previously granted Fast Track; BLA submission anticipated by end of 2026 with potential rolling/priority review.","Designation provides intensive FDA guidance to expedite development and review of the therapy."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-078079","json":"https://secwatch.observer/filing/0000950170-25-078079.json","markdown":"https://secwatch.observer/filing/0000950170-25-078079.md","text":"https://secwatch.observer/filing/0000950170-25-078079.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1841387/000095017025078079/0000950170-25-078079-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1841387/000095017025078079/cadl-20250528.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T08:36:24.419386+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"}