Celldex Initiates Global Phase 3 Trial To Establish Efficacy And Safety Of Barzolvolimab In Adult Patients With ColdU And SD Who Remain Symptomatic Despite H1 Antihistamine Treatment

• No advanced therapies approved to treat ColdU and SD—diseases of misery that dramatically impact all aspects of patient life
• Barzolvolimab is the only drug in development to demonstrate clinical benefit in patients in ColdU and SD in a large, randomized, placebo-controlled study--all primary and secondary endpoints met with high statistical significance at 12 weeks and sustained through end of treatment period (20 weeks) in Phase 2 study
• Initiation of EMBARQ-ColdU and SD marks second barzolvolimab Phase 3 program; Phase 3 in CSU ongoing
  
   

HAMPTON, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today the initiation of its global Phase 3 trial (EMBARQ-ColdU and SD) designed to establish the efficacy and safety of barzolvolimab in adult patients with cold urticaria (ColdU) and symptomatic dermographism (SD) who remain symptomatic despite H1 antihistamine treatment. ColdU and SD are characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival.