{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-21-091151","form_type":"8-K","ticker":"CLDX","cik":"0000744218","company_name":"Celldex Therapeutics, Inc.","filed_at":"2021-07-12T23:59:59+00:00","discovered_at":"2026-05-14T18:04:20.677738+00:00","generated_at":"2026-06-30T06:14:10.890918+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Celldex reports 100% clinical response rate and 95% complete response for CDX-0159 in Phase 1b inducible urticaria","bullets":["19 of 19 patients (100%) showed clinical response; 18 of 19 (95%) achieved complete response by provocation testing.","Rapid onset: complete responses by week 1 (cold urticaria) and week 4 (symptomatic dermographism); median duration 77+ and 57+ days.","Single 3 mg/kg dose suppressed serum tryptase and depleted skin mast cells (87% depletion); well tolerated with mild reversible adverse events.","Subcutaneous formulation enters clinic Q3 2021; Phase 2 urticaria studies start H1 2022; prurigo nodularis study Q4 2021."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-21-091151","json":"https://secwatch.observer/filing/0001104659-21-091151.json","markdown":"https://secwatch.observer/filing/0001104659-21-091151.md","text":"https://secwatch.observer/filing/0001104659-21-091151.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/744218/000110465921091151/0001104659-21-091151-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/744218/000110465921091151/tm2121917d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-30T06:14:10.890918+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"}