Celldex reported Phase 2 PN results for barzolvolimab did not meet the primary or key secondary endpoints, leading to PN discontinuation despite a favorable safety profile and robust mast cell depletion. Phase 3 CSU topline data remain on track for Sept/Oct 2026, with Phase 3 SD and ColdU enrollment continuing and Phase 2 AD data expected late 2026. The news adds near-term uncertainty for CLDX until CSU results.
CLDX announced topline Phase 2 results for barzolvolimab in EoE. While the primary endpoint was met, EoE symptoms showed no improvement. Barzolvolimab has a favorable safety profile but will not advance in EoE. The stock dropped 11.12% following the announcement to $21.35. CLDX remains focused on other indications for barzolvolimab.