Celldex's Barzolvolimab Hits Phase 3 Endpoints in Chronic Urticaria; Shares in Focus

Celldex Therapeutics Inc. (CLDX) reported positive topline results on Tuesday from its Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials of barzolvolimab in patients with chronic spontaneous urticaria (CSU) whose symptoms remain inadequately controlled by H1-antihistamines. The company said both studies met their primary endpoints, supporting the drug's potential in a patient population with limited treatment options. Detailed efficacy and safety data were not disclosed in the initial release. Barzolvolimab is a monoclonal antibody targeting KIT, designed to deplete mast cells implicated in CSU. The readout follows earlier mid-stage data suggesting rapid and durable symptom reduction. Celldex is expected to present full results and discuss regulatory next steps. The CSU market includes competing therapies from Novartis and Roche, intensifying the commercial stakes for the program.