---
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"
generated_at: "2026-09-22T11:10:11.744045+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 1.0
calibrated_materiality_score: 1.0
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: positive
- materiality_score: 1.0
- calibrated_materiality_score: 1.0
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-109465
- JSON: https://secwatch.observer/filing/0001104659-26-109465.json
- Plain text: https://secwatch.observer/filing/0001104659-26-109465.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.