Celldex Presents Positive Data from Phase 2 Chronic Spontaneous Urticaria and Phase 2 Cold Urticaria and Symptomatic Dermographism Studies Demonstrating Rapid, Profound and Durable Improvements in Patient Quality of Life at AAD 2026

- Improvements seen across all six DLQI Domains indicating broad, beneficial impact on quality of life -- Data further demonstrates first-in-class and best-in-disease barzolvolimab profile -

HAMPTON, N.J., March 27, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) presented additional positive data from the completed Phase 2 clinical trials of barzolvolimab in chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) and symptomatic dermographism (SD) demonstrating profound improvements in patient quality of life (QoL) across all measured domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Barzolvolimab is a humanized monoclonal antibody with a completely novel mechanism of action that uniquely targets the root cause of CSU, ColdU and SD—the mast cell. The data were presented at the 2026 Americal Academy of Dermatology (AAD) Annual Meeting being held March 27 – 31, 2026 in Denver, CO.

“Chronic urticarias are devastating diseases of misery that cause immense physical and psychological suffering for patients across all aspects of their daily lives,” said Diane Young, MD, Senior Vice President and Chief Medical Officer of Celldex. “Patients are either directly dealing with intensely itchy, painful burning hives and swelling associated with angioedema or living in fear of their next outbreak. These diseases take an incredible toll on patient quality of life and, sadly, but not surprisingly, recent literature1 shows increased mortality for individuals with CSU as well as increased suicidal ideations and suicide attempts. We are gratified to see barzolvolimab’s profound clinical efficacy also translate to dramatic improvements in patient quality of life—offering new hope for patients and their physicians and supporting barzolvolimab’s profile as a best-in-class, best-in-disease potential treatment option for chronic urticarias.”

Summary of Presentations:

Posters are available on the Celldex website. The Dermatology Life Quality Index2 (DLQI) measures impact of skin disease on quality of life, with a score of 0/1 indicating no effect of the disease on a patient’s life.

Prolonged and Enhanced Quality of Life in Patients with Chronic Spontaneous Urticaria Treated with Barzolvolimab, M. Metz, et al

• As previously reported in the Phase 2 CSU study, up to 51% of patients on study experienced symptom free complete response (UAS7=0; no itch/no hives) at 12 weeks, which continued to deepen over 52 weeks of active therapy to up to 71% of patients. This profound clinical benefit continued even after patients were off therapy—up to 41% of patients reported complete response seven months after receiving their last dose of barzolvolimab.
• In the post hoc analysis presented at AAD, the impact of disease on QoL for the subset of patients who received 52 weeks of barzolvolimab therapy (150 mg Q4W or 300 mg Q8W) and completed treatment with at least well controlled disease (UAS7