{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-043532","form_type":"8-K","ticker":"CADL","cik":"0001841387","company_name":"Candel Therapeutics, Inc.","filed_at":"2024-04-11T23:59:59+00:00","discovered_at":"2026-05-14T18:03:20.677219+00:00","generated_at":"2026-06-04T00:09:26.467974+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Candel Therapeutics receives FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer","bullets":["FDA granted Orphan Drug Designation for CAN-2409 (multimodal immunotherapy) in pancreatic cancer.","Fast Track Designation also previously granted; both designations support development.","Phase 2 data showed median OS 28.8 mo (CAN-2409+SoC) vs 12.5 mo (SoC alone); 24-mo survival 71.4% vs 16.7%.","No new safety signals; CAN-2409 generally well tolerated with no pancreatitis or DLTs.","Orphan Drug status provides tax credits, fee waivers, and 7-year market exclusivity if approved."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-043532","json":"https://secwatch.observer/filing/0000950170-24-043532.json","markdown":"https://secwatch.observer/filing/0000950170-24-043532.md","text":"https://secwatch.observer/filing/0000950170-24-043532.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1841387/000095017024043532/0000950170-24-043532-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1841387/000095017024043532/cadl-20240411.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T00:09:26.467974+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"}