Celldex Advances Barzolvolimab Into Phase 3 for Chronic Inducible Urticaria: What Investors Should Watch

Celldex Therapeutics (CLDX) announced an update on their ongoing clinical study.

Study Overview

Celldex Therapeutics (CLDX) is running a late-stage study called EMBARQ to test its drug barzolvolimab in adults with cold-induced urticaria and symptomatic dermographism who do not respond well to standard H1-antihistamines. The official title is “A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study of Barzolvolimab in Participants With Cold Induced Urticaria and Symptomatic Dermographism (EMBARQ-COLDU and SD).” The goal is to show that barzolvolimab can reduce symptoms and is safe, which would support potential regulatory filings and open a new market in chronic inducible urticaria if successful.

Intervention/Treatment

The study tests barzolvolimab, an injectable drug given under the skin, against a matching placebo. Patients receive a higher “loading” dose of 450 mg at the start, followed by 150 mg every four weeks for 24 weeks. The drug is designed to better control hives and itching in patients whose disease remains active despite current antihistamine therapy.

Study Design

This is an interventional Phase 3 trial with patients randomly assigned to either barzolvolimab or placebo, so each group is comparable. It uses a parallel-group layout, meaning participants stay in their assigned group through the study. The trial is “quadruple-blind,” so patients, doctors, study staff and evaluators do not know who receives the drug or placebo, limiting bias. The main purpose is treatment, aiming to show clear benefits on symptoms and safety versus placebo.

Study Timeline

The study was first submitted on November 19, 2025, marking the move of barzolvolimab into a pivotal Phase 3 setting for this indication. The trial is currently listed as recruiting, which signals that enrollment is still underway and key efficacy data are yet to come. The most recent update was posted on January 5, 2026, confirming that the protocol and status have been reviewed recently. Primary completion and final completion dates are not yet posted, so top-line results likely remain at least several quarters away.

Market Implications

For investors, this update reinforces Celldex’s strategy to position barzolvolimab as a potential new option in chronic inducible urticaria, a niche with high unmet need and limited targeted treatments. A successful Phase 3 outcome could support future revenue from a specialty allergy and dermatology market and may justify a higher valuation multiple for CLDX as the asset de-risks. In the near term, the recruiting status and recent update mainly serve as a confidence check that the program is on track, which can support sentiment but is unlikely to move the stock sharply on its own. Competitive pressure will come from existing antihistamines, biologics used off-label and other mast cell–targeted drugs in development, so investors should watch for signals on differentiation in efficacy, dosing convenience and safety at future readouts. As of the latest update, the study remains active, with further details available on the ClinicalTrials portal.

To learn more about CLDX’s potential, visit the Celldex Therapeutics drug pipeline page.