Celldex Reports Positive Phase 3 Results For Barzolvolimab In CSU

(RTTNews) - Celldex Therapeutics, Inc. (CLDX) Tuesday reported positive topline results from its Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials evaluating barzolvolimab in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines.

Both studies met the primary endpoint, showing a mean change from baseline in weekly urticaria activity score (UAS7) at Week 12. The trials included patients with antihistamine-refractory CSU, including those with prior experience with or refractory disease to advanced therapies.

Chronic spontaneous urticaria is a condition characterized by recurring hives and swelling that occur without a clear or predictable trigger.

Celldex said barzolvolimab demonstrated rapid, sustained efficacy through Week 24, with improvements maintained or deepened from Weeks 12 to 24 across the primary and key secondary endpoints.

The treatment was well tolerated through the 24-week period, with a safety profile consistent with prior Phase 2 results.

The EMBARQ-CSU trials are continuing through 52 weeks. Celldex plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration in 2027.

Celldex shares were down more than 10% in pre-market trading after closing at $37.89 on Monday.