• Study did not meet key efficacy objectives
  • Favorable safety profile consistent with prior studies, including with new 450mg loading dose and up to 300mgQ4W regimen
  • Profound systemic mast cell depletion, as evidenced by significant reduction in serum tryptase, observed
  • Phase 3 CSU topline data expected in Sept/Oct 2026; Phase 3 SD and ColdU Enrollment On Track; Phase 2 topline data in AD in late 2026
  • Company to host webcast today at 4:30 pm ET
     

HAMPTON, N.J., July 21, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported topline results from the Company’s Phase 2 study of barzolvolimab delivered subcutaneously in prurigo nodularis (PN), a chronic skin disease that causes hard, intensely itchy lumps/nodules to form on the skin. The primary endpoint of the study, the proportion of patients who achieve a four point or greater improvement in WI-NRS (Worst Itch Numeric Rating Scale) from baseline to Week 12, and key secondary endpoints were not met.

Barzolvolimab, a humanized monoclonal antibody with a completely novel mechanism of action that uniquely targets the mast cell, is being studied across multiple indications. Profound mast cell depletion as evidenced by significant reduction in serum tryptase was observed and did not result in improvement in itch or skin lesions in patients with PN compared to placebo, indicating mast cells may not be a key pathogenic driver of symptoms in PN. Based on these results, Celldex is discontinuing the Phase 2 study in PN. Consistent with previously reported studies, barzolvolimab demonstrated a favorable safety and tolerability profile.