Celldex says barzolvolimab meets primary endpoint in Phase 3 EMBARQ-CSU studies for chronic spontaneous urticaria
Bitget2026/09/22 10:58- 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: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.
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