Celldex Prepares For 2027 FDA Submission for Chronic Skin Disease

Celldex Therapeutics Inc. (NASDAQ:CLDX) on Tuesday shared topline results from its Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 clinical trials. The studies evaluate barzolvolimab for patients with chronic spontaneous urticaria (CSU) who experience inadequate symptom control using H1-antihistamines, including those who are advanced therapy experienced or refractory. Celldex Therapeutics shares initially traded higher Tuesday before pulling back and turning negative. Read Also: Celldex Treatment Fails To Relieve Chronic Itch, Abandons Prurigo Nodularis Study Phase 3 Trials Meet Primary And Secondary Endpoints The company said that two studies represent the largest clinical program conducted for antihistamine-refractory CSU. Both trials successfully achieved their primary endpoint, demonstrating a highly statistically significant mean change from baseline in the weekly urticaria activity score (UAS7) at the 12-week mark across all dose groups. In addition to the primary goal, the trials met all key secondary endpoints at Week 12. Patients receiving either the 150 mg or 300 mg doses showed profound and rapid improvements in disease activity. Sustained Efficacy And Favorable Safety Profile Trial data highlighted that barzolvolimab’s efficacy deepened or remained sustained between weeks 12 and 24. A significantly higher proportion of treated patients achieved a complete response—meaning the complete absence of itch and hives—compared to those receiving a placebo during the studies. Furthermore, the treatment proved highly effective in a sub-population of patients with CSU that is refractory to Novartis AG’s (NYSE:NVS) Xolair (omalizumab). Treated patients also experienced a statistically higher rate of complete angioedema resolution at Week 12. Barzolvolimab maintained a favorable safety profile and was well-tolerated throughout the 24-week placebo-controlled phase. This safety record remains consistent with prior Phase 2 trial experiences for the drug. Future Plans And FDA Regulatory Strategy The Phase 3 EMBARQ-CSU trials randomized 1,939 patients and will continue active treatment for a total of 52 weeks. After completing the 24-week placebo period, placebo patients transitioned to active treatment groups to continue the trials. A global Phase 3b long-term extension study is currently underway for participants completing the initial trials. Moving forward, the company intends to submit a Biologics License Application to the FDA in 2027. CLDX Price Action: Celldex Therapeutics shares were down 12.51% to $36.65 at the time of publication on Tuesday, according to Benzinga Pro data. Read Also: Iran Hits Back at Trump Over Soaring Fuel Prices — Says Blaming Tehran Is a Symptom of ‘The March of Folly’ Photo via Shutterstock