Celldex barzolvolimab hits all primary and key secondary endpoints in two Phase 3 CSU trials

Celldex Therapeutics, Inc.

• EMBARQ-CSU1/2 met primary endpoint (UAS7) at Week 12; 150mg Q4W change: -20.2 vs placebo -10.7 to -11.4, p<.00001.
• Complete response (UAS7=0) at Week 12: 42-46% on drug vs 9-13% placebo; sustained to Week 24 (45-54% vs 15-18%).
• Omalizumab-refractory subgroup achieved 42-55% complete response at Week 12 vs 9-15% placebo (p≤.009).
• Significant angioedema resolution (AAS7=0) at Week 12: 62-74% on drug vs 34% placebo.
• Safety consistent with prior studies; BLA submission to FDA planned for 2027; trials continue to 52 weeks.