Celldex Therapeutics announced that its Phase 2 study of barzolvolimab met all primary and secondary endpoints in patients with cold urticaria (ColdU) and symptomatic dermographism (SD). At 12 weeks the drug achieved statistically significant improvements, and the benefits were maintained through the 20‑week treatment period, with 78 % of ColdU patients and 58 % of SD patients reporting a partial or complete response.
The high response rates and durable efficacy underscore barzolvolimab’s potential to address unmet needs in chronic inducible urticaria, a condition that currently relies largely on antihistamines. By targeting the KIT receptor and inhibiting mast‑cell activation, the antibody offers a mechanistic advantage that could translate into a transformative therapeutic option for patients who have limited treatment choices.
Celldex plans to launch a Phase 3 trial in both indications in December 2025, a critical step toward regulatory approval and commercialization. The company’s strategy to become a leader in mast‑cell biology is reinforced by this expansion, which could broaden the drug’s commercial reach beyond chronic spontaneous urticaria and open new revenue streams once approval is achieved.
While Celldex is a clinical‑stage company with no current product revenue, its Q3 2024 financials show a net loss of $42.1 million and a cash balance of $756 million, sufficient to fund operations through 2027. The strong pipeline and recent clinical success support continued investor confidence, even as the company remains in the development phase.
Management highlighted the significance of the data, with Senior Vice President and Chief Medical Officer Diane C. Young noting that barzolvolimab “has the potential to transform the treatment landscape for patients with chronic inducible urticaria.” The statement reflects the company’s confidence in the drug’s clinical promise and its broader impact on the mast‑cell therapeutic space.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.