CELLDEX (CLDX) Phase 3 Trials of Barzolvolimab Hit All Endpoints in Hives
Both EMBARQ-CSU studies met primary and all key secondary endpoints, with complete response rates above 42% at week 12; BLA planned for 2027.
Celldex Therapeutics (CLDX) reported positive topline results from its two pivotal Phase 3 trials of barzolvolimab in chronic spontaneous urticaria, with both EMBARQ-CSU1 and EMBARQ-CSU2 meeting the primary endpoint and all key secondary endpoints at 12 weeks across both dose groups. The company said it plans to submit a Biologics License Application to the FDA in 2027.
