Barzolvolimab (CDX-0159) - (EMBARQ-CSU1)

August 6, 2026: Celldex (NASDAQ: CLDX) reported a corporate update centered on barzolvolimab and CDX-622. For barzolvolimab in chronic spontaneous urticaria, Phase 3 EMBARQ-CSU1 and CSU2 are ongoing after enrolling 1,939 antihistamine-refractory patients across 43 countries and 500+ sites; topline data are expected in September/October 2026, with a BLA submission planned for 2027. In cold urticaria and symptomatic dermographism, the Phase 3 EMBARQ-ColdU/-SD study, initiated in December 2025, is actively enrolling; the company said prior Phase 2 data met all primary and secondary endpoints at 12 weeks and were sustained through 20 weeks.

For other barzolvolimab indications, Phase 2 atopic dermatitis enrollment is complete, with topline data expected in late 2026. In prurigo nodularis, Phase 2 topline data presented in July 2026 showed the study did not meet the primary or key secondary endpoints; barzolvolimab was well tolerated, and Celldex is discontinuing the PN study. At EAACI in June 2026, long-term CSU data showed up to 64% of patients with baseline angioedema remained angioedema-free seven months after dosing ended.

For CDX-622, June 2026 Phase 1 first-in-human data showed rapid, profound, dose-dependent, durable serum tryptase reductions and good tolerability, with no dose-limiting toxicities or related serious adverse events. A Phase 1 proof-of-mechanism asthma study started in January 2026 and is ongoing.