Celldex Reports Topline Results From The Company’s Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Trials Evaluating Two Doses Of Barzolvolimab In Patients With Chronic Spontaneous Urticaria; Results Showed Rapid, Profound, Sustained Efficacy, Supporting Barzolvolimab’s Potential To Be A Transformational Therapy In CSU
Benzinga Newsdesk 1 month ago
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EMBARQ-CSU1 and -CSU2 met primary and all key secondary endpoints at 12 weeks across both studies and both dose groupsClinically meaningful and statistically significant benefit demonstrated in omalizumab refractory CSU
- EMBARQ-CSU1 and -CSU2 met primary and all key secondary endpoints at 12 weeks across both studies and both dose groups
- Clinically meaningful and statistically significant benefit demonstrated in omalizumab refractory CSU and patients with severe disease or severe angioedema
- Efficacy sustained or deepened from weeks 12 to 24
- Well tolerated with a favorable safety profile through 24 weeks; consistent with prior studies
- Treatment will continue in both trials to 52 weeks; BLA submission anticipated in 2027
- Company to host webcast today at 8:00 am ET