Celldex Announces Positive Results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Studies of Barzolvolimab Which Met Primary and All Key Secondary Endpoints
Phase 3positivebarzolvolimabPositive
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Summary
Celldex announced positive Phase 3 results for barzolvolimab in chronic spontaneous urticaria, with both EMBARQ-CSU1 and EMBARQ-CSU2 trials meeting primary and key secondary endpoints. The company plans to submit a BLA to the FDA in 2027.
Clinical Trial Data
Phase
Phase 3
Primary Endpoint
Met
Outcome Details
Both EMBARQ-CSU1 and EMBARQ-CSU2 trials met primary endpoint of mean change from baseline in weekly urticaria activity score (UAS7) at Week 12 and all key secondary endpoints
Importance:8/10
Sentiment:
0.90
Phase 3 datapositive resultsprimary endpoint metsecondary endpoints metBLA submission planneddermatologyimmunology
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Published by GlobeNewswire Clinical Studies on September 22, 2026 10:58 AM