{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-109465","form_type":"8-K","ticker":"CLDX","cik":"0000744218","company_name":"Celldex Therapeutics, Inc.","filed_at":"2026-09-22T11:09:01+00:00","discovered_at":"2026-09-22T11:10:00.273228+00:00","generated_at":"2026-09-22T11:10:11.744045+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":1.0,"calibrated_materiality_score":1.0,"confidence":"high","headline":"Celldex barzolvolimab hits all primary and key secondary endpoints in two Phase 3 CSU trials","bullets":["EMBARQ-CSU1/2 met primary endpoint (UAS7) at Week 12; 150mg Q4W change: -20.2 vs placebo -10.7 to -11.4, p<.00001.","Complete response (UAS7=0) at Week 12: 42-46% on drug vs 9-13% placebo; sustained to Week 24 (45-54% vs 15-18%).","Omalizumab-refractory subgroup achieved 42-55% complete response at Week 12 vs 9-15% placebo (p≤.009).","Significant angioedema resolution (AAS7=0) at Week 12: 62-74% on drug vs 34% placebo.","Safety consistent with prior studies; BLA submission to FDA planned for 2027; trials continue to 52 weeks."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-109465","json":"https://secwatch.observer/filing/0001104659-26-109465.json","markdown":"https://secwatch.observer/filing/0001104659-26-109465.md","text":"https://secwatch.observer/filing/0001104659-26-109465.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/744218/000110465926109465/0001104659-26-109465-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/744218/000110465926109465/tm2625892d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-22T11:10:11.744045+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"}