secwatch.observer — SEC 8-K summary
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Issuer:     Celldex Therapeutics, Inc. (CLDX)
CIK:        0000744218
Form:       8-K
Filed at:   2025-08-19T23:59:59+00:00
Accession:  0001104659-25-080248
Event type: other_material
Sentiment:  negative
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Celldex Phase 2 barzolvolimab in EoE meets primary endpoint but no clinical benefit; advancement stopped
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/744218/000110465925080248/0001104659-25-080248-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/744218/000110465925080248/tm2523903d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-080248

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer