{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-080248","form_type":"8-K","ticker":"CLDX","cik":"0000744218","company_name":"Celldex Therapeutics, Inc.","filed_at":"2025-08-19T23:59:59+00:00","discovered_at":"2026-05-14T18:02:46.271709+00:00","generated_at":"2026-05-17T11:38:38.724543+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Celldex Phase 2 barzolvolimab in EoE meets primary endpoint but no clinical benefit; advancement stopped","bullets":["Primary endpoint met: peak mast cell count reduced by -36.0 vs placebo -2.7 (p<0.0001) at Week 12.","No improvement in Dysphagia Symptom Questionnaire (DSQ) (p=0.33) or endoscopic EREFS score (p=0.95).","Company will not advance barzolvolimab in EoE; safety profile favorable at 300 mg Q4W.","Pipeline continues in chronic spontaneous urticaria, atopic dermatitis, prurigo nodularis, and inducible urticaria.","Full study (28-week treatment, 44-week total) outcomes consistent with 12-week results."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-080248","json":"https://secwatch.observer/filing/0001104659-25-080248.json","markdown":"https://secwatch.observer/filing/0001104659-25-080248.md","text":"https://secwatch.observer/filing/0001104659-25-080248.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/744218/000110465925080248/0001104659-25-080248-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/744218/000110465925080248/tm2523903d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T11:38:38.724543+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"}