adminBy Colin Kellaher
Celldex Therapeutics shares jumped more than 30% in premarket trading Monday after the clinical-stage biotechnology company said a Phase 2 study of its lead product candidate barzolvolimab met its key goal in severe chronic spontaneous urticaria.
Celldex shares, which closed Friday at $25.98, were recently up 31% to $34.06.
The Hampton, N.J., company said the study in patients with moderate to severe chronic spontaneous urticaria refractory to antihistamines, including patients who received prior biologics, met its primary efficacy endpoint, with a statistically significant mean change from baseline to week 12 compared to a placebo.
Celldex said treatment options are limited for patients with chronic spontaneous urticaria, which is characterized by the occurrence of hives or weals for six weeks or longer without identifiable specific triggers or causes, adding that there are no approved therapies for patients who don’t respond to omalizumab, an anti-inflammatory marketed by Novartis as Xolair.
Celldex said barzolvolimab was generally well-tolerated, with a favorable safety profile, adding that the results support further development in Phase 3 studies.
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