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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Celldex Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202609220658PRIMZONEFULLFEED9831290) on September 22, 2026, and is solely responsible for the information contained therein.