Celldex Therapeutics presented Phase 2 data for its lead antibody barzolvolimab at the 2026 Allergy, Asthma & Immunology Annual Meeting on February 27, 2026. The data demonstrate sustained off‑treatment efficacy in patients with chronic spontaneous urticaria (CSU), with 41 % of participants reporting a complete response seven months after their last dose and normalized tryptase levels indicating durable mast‑cell depletion.
The study also showed significant quality‑of‑life improvements in patients with cold urticaria (ColdU) and symptomatic dermographism (SD). At week 20, 66 % of ColdU patients and 49 % of SD patients achieved a complete response, with rapid symptom relief and a marked reduction in angioedema episodes. These results underscore barzolvolimab’s potential to address unmet needs in these rare urticaria subtypes.
Celldex’s Phase 3 programs in CSU and ColdU/SD are progressing strongly. Enrollment in the global Phase 3 CSU trial was completed six months ahead of schedule, a milestone that de‑risks the program and accelerates the path to regulatory submission. The company also continues Phase 2 studies in prurigo nodularis and atopic dermatitis, and a Phase 1 bispecific antibody, CDX‑622, is underway.
Financially, Celldex remains a clinical‑stage company with no product revenue. Q4 2025 revenue fell to $0.1 million from $1.2 million in Q4 2024, and the full‑year 2025 revenue was $1.5 million versus $7.0 million in 2024. Net losses widened to $81.3 million in Q4 2025 from $47.1 million in Q4 2024, and the full‑year 2025 net loss was $258.8 million compared with $157.9 million in 2024. The company’s cash, cash equivalents and marketable securities totaled $518.6 million as of December 31, 2025, providing a runway through 2027.
Management emphasized the significance of the data. CEO Anthony S. Marucci said, "The enthusiasm for barzolvolimab continues to build, driven by unparalleled efficacy data across multiple indications. This is underscored by the completion of enrollment in our Phase 3 CSU studies six months ahead of guidance and strong interest from clinical trial sites in our recently initiated Phase 3 study in cold urticaria and symptomatic dermographism." Chief Medical Officer Diane C. Young added, "Barzolvolimab's novel mechanism of action uniquely targets the root cause of chronic urticarias—the mast cell—and is driving the unparalleled efficacy we are seeing across our studies in chronic spontaneous urticaria, cold urticaria and symptomatic dermographism. The data presented at AAAAI continue to demonstrate that barzolvolimab has the potential to transform the treatment landscape by providing rapid, profound and durable efficacy, including symptom free complete control and dramatic improvements in quality of life and angioedema—offering new hope for the patients suffering from these often severe and debilitating diseases."
The market reaction to the announcement was positive, driven by the early completion of Phase 3 enrollment and the robust Phase 2 data. Investors and analysts noted the milestone as a key de‑risking event that strengthens the company’s clinical development strategy and supports the outlook for future data readouts in 2026 and beyond.
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