Celldex Therapeutics' Barzolvolimab Meets Phase 3 Endpoints in Two Urticaria Trials

07:31 AM EDT, 09/22/2026 (MT Newswires) -- Celldex Therapeutics' (CLDX) two Phase 3 trials of barzolvolimab in patients with chronic spontaneous urticaria met their primary and all key secondary endpoints at 12 weeks, the company said Tuesday. The trials are evaluating two doses of barzolvolimab, both of which met the primary endpoint of mean change from baseline in weekly urticaria activity score at week 12, Celldex said. Celldex said more patients receiving barzolvolimab achieved complete resolution of hives and itching, with complete response rates at Week 12 ranging from 42.1% to 45.7% across the two doses and studies, compared with 9.3% to 12.6% for placebo. With the achievement of key secondary endpoints, the trials demonstrated clinically meaningful improvements in disease activity, the company added. Barzolvolimab was also well tolerated, with a safety profile consistent with the Phase 2 trial, according to Celldex. The Phase 3 studies are ongoing, expected to continue through 52 weeks, and Celldex said it plans to submit a biologics license application for barzolvolimab in the US in 2027.