---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-21-091151"
form_type: "8-K"
ticker: "CLDX"
cik: "0000744218"
company_name: "Celldex Therapeutics, Inc."
filed_at: "2021-07-12T23:59:59+00:00"
generated_at: "2026-06-30T06:14:10.890918+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Celldex reports 100% clinical response rate and 95% complete response for CDX-0159 in Phase 1b inducible urticaria

## Summary
- 19 of 19 patients (100%) showed clinical response; 18 of 19 (95%) achieved complete response by provocation testing.
- Rapid onset: complete responses by week 1 (cold urticaria) and week 4 (symptomatic dermographism); median duration 77+ and 57+ days.
- Single 3 mg/kg dose suppressed serum tryptase and depleted skin mast cells (87% depletion); well tolerated with mild reversible adverse events.
- Subcutaneous formulation enters clinic Q3 2021; Phase 2 urticaria studies start H1 2022; prurigo nodularis study Q4 2021.

## SEC filing metadata
- accession: 0001104659-21-091151
- form_type: 8-K
- ticker: CLDX
- cik: 0000744218
- company_name: Celldex Therapeutics, Inc.
- filed_at: 2021-07-12T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/744218/000110465921091151/0001104659-21-091151-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/744218/000110465921091151/tm2121917d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-21-091151
- JSON: https://secwatch.observer/filing/0001104659-21-091151.json
- Plain text: https://secwatch.observer/filing/0001104659-21-091151.txt

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