Celldex Reports Topline Results From The Company’s Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Trials Evaluating Two Doses Of Barzolvolimab In Patients With Chronic Spontaneous Urticaria; Results Showed Rapid, Profound, Sustained Efficacy, Supporting Barzolvolimab’s Potential To Be A Transformational Therapy In CSU

Celldex reported positive topline results from its Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials for Barzolvolimab, showing that both studies met primary and key secondary endpoints at 12 weeks. The treatment demonstrated significant efficacy in patients with chronic spontaneous urticaria (CSU), particularly those refractory to omalizumab and with severe disease. The therapy was well tolerated, and the company plans to continue treatment in both trials for up to 52 weeks, with a Biologics License Application (BLA) submission expected in 2027.