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Landon Capital

This is just a phase, Celldex stock rises after positive phase 3 trial results

Celldex Therapeutics (NASDAQ: CLDX) shares rose 8% Tuesday after the company announced positive topline results from its Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials of barzolvolimab in patients with chronic spontaneous urticaria (CSU).

Both Phase 3 trials met the primary endpoint of mean change from baseline in weekly urticaria activity score (UAS7) at Week 12, and all key secondary endpoints, demonstrating clinically meaningful and statistically significant improvements in disease activity. The EMBARQ-CSU1 and EMBARQ-CSU2 studies are the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced or refractory CSU.

In EMBARQ-CSU1, the 150 mg dose showed a mean change of -20.2 at Week 12 compared to -10.7 for placebo, while the 300 mg dose showed a mean change of -20.5. In EMBARQ-CSU2, the 150 mg dose showed a mean change of -20.2 compared to -11.4 for placebo, while the 300 mg dose showed a mean change of -19.7. All results were statistically significant with p-values below 0.00001.