Celldex Therapeutics presented data from its Phase 2 studies of barzolvolimab at the American Academy of Dermatology (AAD) 2026 conference, confirming the antibody’s efficacy in chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) with symptomatic dermographism (SD). The company reported that 77 % of CSU patients were angioedema‑free at 52 weeks, 71 % achieved a complete response (UAS7 = 0) at the same time point, and 82 % reported no impact of CSU symptoms on their quality of life. In the ColdU/SD cohort, 66 % of ColdU patients and 49 % of SD patients achieved a complete response at 20 weeks, with sustained benefits over the treatment period.
The barzolvolimab Phase 2 study in eosinophilic esophagitis (EoE) met its primary endpoint of mast cell depletion but did not translate into clinical improvement. Celldex has therefore decided not to advance the program in EoE, underscoring that mast cells may not be the primary driver of that disease.
In addition to the urticaria data, Celldex presented early results from a Phase 1/2 trial of its T‑cell receptor fusion construct, gavocabtagene autoleucel (gavo‑cel), in advanced solid tumors. The study reported a 77 % disease‑control rate and 93 % tumor regression in the treated cohort, but highlighted a narrow therapeutic window and dose‑limiting toxicities that will shape future development plans.
"The enthusiasm for barzolvolimab continues to build, driven by unparalleled efficacy data across multiple indications," said Anthony Marucci, Co‑founder, President and Chief Executive Officer of Celldex. "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."
"In the second quarter of 2025 data from our now completed Phase 2 study in chronic spontaneous urticaria were presented that we believe clearly show that barzolvolimab is best in disease and achieves the goal of treatment for patients and physicians—rapid, profound, durable complete response which is correlated with meaningful improvements in quality of life," said Marucci. "As we explore barzolvolimab's full potential as a mast cell depleting agent, we are ultimately defining which diseases are mast cell driven."
The positive Phase 2 results position barzolvolimab as a best‑in‑disease therapy for urticaria and support its progression into global Phase 3 trials. The company’s decision to halt the EoE program reflects a data‑driven focus on indications with clear clinical benefit, while the gavo‑cel data will inform the design of future oncology studies. Celldex remains financially robust, with $518.6 million in cash and marketable securities as of December 31 2025, providing a runway to fund the upcoming Phase 3 studies and continued clinical development.
The announcement underscores Celldex’s strategic shift toward high‑impact, mast‑cell‑driven therapies and signals confidence in the company’s pipeline, potentially influencing long‑term investment theses.
The content on EveryTicker 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.