Other Events ·
Celldex Therapeutics announced positive topline results from its Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials of…
CLDXCelldex Therapeutics, Inc.
Celldex Therapeutics announced positive topline results from its Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials of barzolvolimab in chronic spontaneous urticaria (CSU). Both studies met their primary endpoint of mean change from baseline in weekly urticaria activity score at Week 12, as well as all key secondary endpoints. The drug demonstrated statistically significant improvements across both the 150 mg and 300 mg dose groups compared to placebo, with high rates of complete response observed in patients refractory to omalizumab and those with severe disease or angioedema. Barzolvolimab showed a favorable safety profile through Week 24. The company plans to submit a Biologics License Application to the FDA in 2027. Celldex Therapeutics is a biopharmaceutical company developing novel antibody-based treatments for allergic, inflammatory, and autoimmune disorders.