Positive Results for Phase 2 Study of Barzolvolimab in Chronic Spontaneous Urticaria

Shares of Celldex Therapeutics witnessed a significant surge of over 30% during premarket trading on Monday. The clinical-stage biotechnology company announced that its lead product candidate, barzolvolimab, successfully achieved its primary efficacy endpoint in a Phase 2 study focusing on severe chronic spontaneous urticaria.

A Breakthrough Treatment for Chronic Spontaneous Urticaria

Celldex Therapeutics' shares soared to $34.06 from their previous close at $25.98 in response to the promising findings. This New Jersey-based firm highlighted that their study included patients with moderate to severe chronic spontaneous urticaria who did not respond to antihistamines, including those who had previously undergone other biologics treatments.

The results demonstrated a statistically significant mean change from baseline to week 12 when compared to a placebo. This breakthrough is particularly significant given the limited treatment options currently available for patients with chronic spontaneous urticaria, a condition characterized by the occurrence of hives or weals for an extended period of time without identifiable triggers or causes. Celldex also mentioned that there are no approved therapies for patients who do not respond to omalizumab, an anti-inflammatory drug marketed as Xolair by Novartis.

Promising Safety Profile and the Path Forward

Celldex Therapeutics emphasized that barzolvolimab demonstrated a favorable safety profile and was well-tolerated by patients. The positive results from this Phase 2 study provide solid support for further development, with Phase 3 studies being the next step.