Celldex says barzolvolimab meets primary endpoint in Phase 3 EMBARQ-CSU studies for chronic spontaneous urticaria

Celldex reported positive topline Phase 3 results for barzolvolimab in chronic spontaneous urticaria patients inadequately controlled by H1-antihistamines.

• Both EMBARQ-CSU1 and EMBARQ-CSU2 met the primary endpoint and all key secondary endpoints, showing rapid, sustained symptom improvement.
• Benefits extended to harder-to-treat groups, including omalizumab-refractory patients and those with severe disease or angioedema.
• Safety through 24 weeks was consistent with earlier studies; both trials continue to 52 weeks.
• Results will be presented at a future medical meeting; an FDA BLA filing is planned for 2027.