Core Insights - Celldex Therapeutics announced that barzolvolimab significantly improves angioedema in chronic spontaneous urticaria (CSU) patients after 52 weeks of treatment [1][2][3] Group 1: Clinical Trial Results - The Phase 2 clinical trial met primary and secondary endpoints at 12 weeks, showing significant decreases in UAS7 scores compared to placebo [2][5] - At Week 52, an 86% mean reduction in angioedema activity was reported for the 150 mg Q4W group, and an 82% reduction for the 300 mg Q8W group [6] - 77% of patients treated with barzolvolimab who had angioedema at baseline were angioedema-free at Week 52 [5][6] Group 2: Patient Impact - The majority of patients with severe CSU experience painful angioedema, which significantly affects their quality of life [3][6] - 87% of patients reported clinically meaningful improvement in angioedema activity scores at Week 52 [6] Group 3: Drug Mechanism and Future Studies - Barzolvolimab is a humanized monoclonal antibody that targets the receptor tyrosine kinase KIT, which is involved in mast cell activation [4] - Celldex is conducting a global Phase 3 program for barzolvolimab in CSU, with enrollment currently underway [8]

Barzolvolimab Phase 2 CSU 76 Week Data 7 MONTHS POST ACTIVE THERAPY 2 01 Introduction Anthony Marucci, President & CEO 3 Barzolvolimab Best in Disease for All Patients1 EAACI 2025 Safe Harbor Statement This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our us ...

Core Insights - Celldex announced new data showing significant and sustained complete response in chronic spontaneous urticaria (CSU) patients treated with barzolvolimab, with improvements in quality of life observed at 76 weeks post-treatment [1][2][3] Efficacy Data - The Phase 2 study met its primary endpoint, showing a significant improvement in UAS7 (weekly urticaria activity score) compared to placebo at 12 weeks across all dose groups [2][11] - At 12 weeks, up to 51% of patients achieved a complete response (UAS7=0), which increased to 71% at 52 weeks, and 41% maintained this response at 76 weeks [2][6] - 48% of patients reported that CSU no longer impacted their quality of life at 76 weeks, as measured by the Dermatology Life Quality Index (DLQI) [5][6] Safety Profile - Barzolvolimab demonstrated a well-tolerated safety profile throughout the study, with the most common adverse events being mild and reversible [7][3] - No new safety signals were identified, and neutropenia events resolved rapidly without association to infections [7][3] Future Developments - Enrollment for Phase 3 trials of barzolvolimab in CSU is ongoing, with two global Phase 3 trials designed to establish efficacy and safety in patients who remain symptomatic despite antihistamine treatment [12][11] - The company is focused on executing clinical trials to bring this potential new treatment to patients suffering from CSU [8][14]

Company to host webcast on Thursday, June 12 at 6:00 pm ETHAMPTON, N.J., June 10, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today that data from the Company’s Phase 2 study of barzolvolimab in chronic spontaneous urticaria will be presented at the EAACI Congress 2025 being held in Glasgow, Scotland. Abstracts will be available on the meeting website Thursday, June 12th at 6:01 pm ET/ Friday, June 13th at 12:01 am CEST. Celldex will host a webcast on Thursday, June 12th at 6:00 pm ET to discus ...

Core Insights - Celldex Therapeutics, Inc. has elected Denice M. Torres to its Board of Directors, bringing extensive leadership experience from the pharmaceutical and consumer healthcare sectors [1][2] - Torres expressed enthusiasm about joining Celldex at a pivotal time, highlighting the company's progress with barzolvolimab and its potential to improve treatment standards for patients [2] Company Overview - Celldex is a clinical stage biotechnology company focused on developing therapeutics that engage the human immune system to treat severe inflammatory, allergic, autoimmune, and other diseases [3]

Strong execution and progress across pipeline with multiple key data read outs expected in 2025Late breaking oral presentation on Phase 2 CSU program at EAACI 2025 in JunePhase 3 barzolvolimab CSU studies enrollment ongoing; Phase 3 program in CIndU under developmentPhase 2 EOE study enrollment complete; ongoing enrollment in Phase 2 PN and AD studiesCelldex’s first bispecific for inflammatory diseases, CDX-622, Phase 1 study ongoing HAMPTON, N.J., May 08, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. ...

HAMPTON, N.J., May 05, 2025 (GLOBE NEWSWIRE) -- Celldex announced today the presentation of histology data from the Company’s ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE). Biopsies taken during screening demonstrate the presence of high numbers of intraepithelial mast cells in participants with active EoE and correlate with eosinophil counts, supporting the hypothesis that treating EoE with barzolvolimab—a mast cell depleting agent—could provide promising therapeutic benefit. The ...