Why Is Inflammation Disease-Focused Celldex Therapeutics Stock Trading Higher Today?

Celldex Therapeutics Inc CLDX released topline results from its Phase 2 trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients who received prior biologics. 

CSU is characterized by the occurrence of hives or wheals for six weeks or longer without identifiable specific triggers or causes. 

Data from the 208 patients randomized in the study showed that barzolvolimab achieved the primary efficacy endpoint, with a statistically significant mean change from baseline to week 12 of UAS7 (urticaria activity score) compared to placebo. 

Barzolvolimab demonstrated rapid, durable, and clinically meaningful responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment. 

The mean change from baseline to week 12 in UAS7 was -23.87 in the 300 mg q8w dose group and -23.02 in the 150 mg q4w dose group.

Barzolvolimab was generally well tolerated with a favorable safety profile. Treatment will continue for 52 weeks.

Price Action: CLDX shares are up 25.00% at $32.48 on the last check Friday.