Celldex Announces Positive Results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Studies of Barzolvolimab Which Met Primary and All Key Secondary Endpoints
HAMPTON, N.J., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported positive 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 (CSU) whose symptoms are inadequately controlled by H1-antihistamines. The EMBARQ-CSU1 and EMBARQ-CSU2 studies are the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. Both Phase 3 trials met the primary endpoint of mean change from baseline in weekly urticaria activity score (UAS7) at Week 12, and all key secondary endpoints, demonstrating clinically meaningful and statistically significant improvements in disease activity. Barzolvolimab was well-tolerated through the 24 week placebo controlled treatment period with a favorable safety profile consistent with prior Phase 2 experience. The EMBARQ-CSU trials are ongoing, with treatment continuing through 52 weeks. The Company intends to present the EMBARQ-CSU data at an upcoming medical meeting and plans to submit a Biologics License Application (BLA) to the FDA in 2027.