secwatch.observer — SEC 8-K summary
======================================

Issuer:     Celldex Therapeutics, Inc. (CLDX)
CIK:        0000744218
Form:       8-K
Filed at:   2021-07-12T23:59:59+00:00
Accession:  0001104659-21-091151
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/744218/000110465921091151/0001104659-21-091151-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/744218/000110465921091151/tm2121917d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-21-091151

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