Celldex Therapeutics reported that its experimental skin-disease drug met both primary and secondary endpoints in two Phase 3 trials, signaling a potential regulatory pathway. While safety details were not disclosed, the milestone strengthens the pipeline and could spark deal activity or licensing discussions if full results confirm the top-line findings, potentially lifting CLDX shares in the near term.
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.