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StocksMediumUpdated•Originally published 22 September 2026•Updated 22 September 2026•
2 min read

Celldex’s Barzolvolimab Meets Goals in Both Phase 3 Chronic Hives Trials

Key Facts

1Both Phase 3 trials met the primary and all key secondary endpoints at Week 12.
2The trials enrolled 1,939 patients.
3At Week 24, complete response rates were 49.0% and 54.0% with 150 mg, versus 15.4% and 17.6% with placebo.
4The company plans to submit a BLA to the FDA in 2027.

Celldex Therapeutics said on September 22, 2026 that barzolvolimab met the primary and all key secondary endpoints at Week 12 in the Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials. The studies tested the drug in patients with chronic spontaneous urticaria whose symptoms remained inadequately controlled by H1 antihistamines.

The trials enrolled 1,939 patients and assigned them to 150 mg every 4 weeks, 300 mg every 8 weeks or placebo. At Week 12, the mean change in the weekly urticaria activity score, UAS7, was -20.2 points with 150 mg in both trials and -20.5 and -19.7 points with 300 mg, versus -10.7 and -11.4 points with placebo; every active-placebo comparison had p<0.00001.

At Week 24, complete response rates, defined as no itch or hives and UAS7=0, were 49.0% and 54.0% with 150 mg, compared with 15.4% and 17.6% for placebo. Barzolvolimab targets KIT, a receptor required for mast-cell function and survival; because mast-cell activation plays a central role in chronic urticaria, inhibiting these cells provides the mechanism for reducing itch and hives.

The company said barzolvolimab was well tolerated through Week 24 and that treatment will continue through Week 52. Celldex plans to submit a Biologics License Application to the FDA in 2027, but these company-reported topline results do not constitute regulatory approval.