Celldex Therapeutics said barzolvolimab met the primary and all key secondary endpoints in its Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials for chronic spontaneous urticaria inadequately controlled by H1-antihistamines. The studies enrolled 1,939 patients and tested 150 mg and 300 mg doses, with benefits sustained or deepening through week 24. The drug also produced complete responses among patients whose disease was resistant to Xolair, including rates of 55.3% and 41.7% for the 150 mg dose across the two trials at week 12, compared with 9.3% and 15.1% for placebo. Complete angioedema resolution was also significantly higher among treated patients. Celldex said two patients experienced anaphylaxis after administration, while overall discontinuation was 16%, driven mainly by patients withdrawing consent. Shares initially rose before turning lower. H.C. Wainwright subsequently upgraded Celldex to Buy and raised its price target to $64 from $42 following the successful Phase 3 trials. Treatment will continue through 52 weeks, with a global Phase 3b extension underway, and Celldex plans to submit a Biologics License Application to the FDA in 2027.