secwatch.observer — SEC 8-K summary
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Issuer:     Celldex Therapeutics, Inc. (CLDX)
CIK:        0000744218
Form:       8-K
Filed at:   2026-09-22T11:09:01+00:00
Accession:  0001104659-26-109465
Event type: other_material
Sentiment:  positive
Materiality: 1.00
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Celldex barzolvolimab hits all primary and key secondary endpoints in two Phase 3 CSU trials
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/744218/000110465926109465/0001104659-26-109465-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/744218/000110465926109465/tm2625892d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-109465

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