Celldex's Barzolvolimab Clears Two Phase 3 Trials in Chronic Hives, But Shares Sink on Safety Signal
- Celldex's barzolvolimab met the primary endpoint and key secondary endpoints in two Phase 3 trials for antihistamine-refractory chronic hives, with effects deepening through week 24.
- The trials enrolled about 1,900 patients at 500+ sites in 43 countries, the largest program yet in this antihistamine-resistant population.
- Shares still fell sharply, as investors weighed two reported anaphylaxis cases and a BLA filing not expected until 2027.
💡 Points
Depleting mast cells directly — not just blocking IgE — is barzolvolimab's real differentiation from Xolair, giving Celldex a real shot at antihistamine/omalizumab failures. But anaphylaxis in a mast-cell-targeted drug is mechanistically uncomfortable, not just noise, and a 2027 BLA means years of cash burn — pressure toward partnership over solo launch.
Celldex monoclonal antibody rebounds with pair of phase 3 wins for chronic skin condition ↗