Celldex Announces Positive Results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Studies of Barzolvolimab Which Met Primary and All Key Secondary Endpoints

* Best-in-disease results showed rapid, profound, sustained efficacy, supporting barzolvolimab’s potential to be a transformational therapy in CSU * EMBARQ-CSU1 and -CSU2 met primary and all key secondary endpoints at 12 weeks across both studies and both dose groups * Clinically meaningful and statistically significant benefit demonstrated in omalizumab refractory CSU and patients with severe disease or severe angioedema * Efficacy sustained or deepened from weeks 12 to 24 * Well tolerated with a favorable safety profile through 24 weeks; consistent with prior studies * Treatment will continue in both trials to 52 weeks; BLA submission anticipated in 2027 * Company to host webcast today at 8:00 am ET 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.