Celldex Therapeutics (CLDX) Stock News

Celldex (NASDAQ:CLDX) reported positive Phase 1 data for CDX-622, a bispecific antibody targeting stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP), presented Oct 30, 2025.

Key results: well tolerated in 32 healthy participants across 4 IV dose cohorts (0.3–9.0 mg/kg), no dose-limiting toxicities, no serious adverse events, no antidrug antibodies, mAb-like PK with ~18-day half-life at 9 mg/kg, and a ~50% sustained reduction in serum tryptase over 12 weeks after a single dose. NOAEL in GLP tox was the highest tested dose (75 mg/kg) with profound tissue mast cell depletion. Company advanced to multiple ascending doses and plans to report Parts 2/3 data in Q3 2026 and initiate a Phase 1b asthma study thereafter.

Celldex (NASDAQ:CLDX) presented new Phase 2 data for barzolvolimab in chronic spontaneous urticaria (CSU) at EADV Congress 2025. The drug showed rapid and sustained efficacy regardless of patients' baseline immunoglobulin E (IgE) levels.

Key findings demonstrate that barzolvolimab achieved complete response rates of up to 51% at 12 weeks, increasing to 71% at 52 weeks. Notably, 41% of patients maintained complete response even 7 months after treatment completion. The drug works by targeting mast cells through the KIT receptor, showing particular promise for patients with low IgE levels who typically have more severe disease and respond poorly to existing treatments.

The company is currently conducting two global Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) to further evaluate the drug's efficacy and safety in CSU patients who remain symptomatic despite antihistamine or biologic treatments.

Celldex Therapeutics (NASDAQ:CLDX) announced its management team will participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9th, 2025, at 3:20 pm ET.

Investors can access a live webcast of the presentation through the "Events & Presentations" page in the "Investors" section of Celldex's website. The presentation recording will remain available for 90 days after the event.

Celldex Therapeutics (NASDAQ:CLDX) announced topline results from its Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE). While the study met its primary endpoint by demonstrating significant mast cell depletion in the gastrointestinal tract, it failed to show clinical improvement in EoE symptoms compared to placebo.

The trial showed that peak mast cell counts decreased by 36.0 in the barzolvolimab arm versus 2.7 in placebo (p0.0001). However, no definitive evidence of clinical improvement was observed in dysphagia symptoms or endoscopic scoring. Based on these results, but continues to progress barzolvolimab in other indications, including two Phase 3 studies in chronic spontaneous urticaria and Phase 2 studies in atopic dermatitis and prurigo nodularis.

Celldex Therapeutics (NASDAQ:CLDX) reported Q2 2025 financial results and pipeline updates. The company's lead drug barzolvolimab demonstrated exceptional results in Phase 2 chronic spontaneous urticaria (CSU) studies, with up to 41% of patients maintaining complete response 7 months after treatment completion.

Financial highlights include $630.3 million in cash reserves (sufficient through 2027), Q2 net loss of $56.6 million ($0.85 per share), and increased R&D expenses of $54.2 million. The company is advancing its global Phase 3 program in CSU with two trials enrolling approximately 915 patients each.

Multiple data readouts are expected in 2H 2025, including results from Phase 2 studies in eosinophilic esophagitis (EoE) and chronic inducible urticaria (CIndU), along with Phase 1 data from CDX-622 in healthy volunteers.

Celldex Therapeutics (NASDAQ:CLDX) presented positive 52-week data from their Phase 2 trial of barzolvolimab in chronic spontaneous urticaria (CSU) at EAACI 2025. The study showed remarkable improvements in angioedema symptoms, with 77% of patients in the 150 mg Q4W group becoming angioedema-free at Week 52. The drug demonstrated an 86% mean reduction from baseline in the 150 mg Q4W arm and 82% reduction in the 300 mg Q8W arm. The trial, which previously met its primary and secondary endpoints at 12 weeks, showed patients were angioedema-free up to 72% of the time over the 52-week treatment period. Up to 87% of patients reported clinically meaningful improvement in AAS7 scores at Week 52. The study population had severe CSU, with over 70% of patients having a UAS7 score greater than 28 at baseline.

Celldex (NASDAQ:CLDX) announced groundbreaking 76-week results for barzolvolimab in treating chronic spontaneous urticaria (CSU). The Phase 2 study showed remarkable sustained benefits 7 months after treatment completion, with 41% of patients on 150 mg Q4W maintaining complete response (UAS7=0) and 48% reporting no quality of life impact. The drug, which targets mast cells through KIT receptor inhibition, demonstrated rapid efficacy across all dose groups, with improvements visible within one week. The study met its primary endpoint with significant UAS7 improvements versus placebo at 12 weeks. Notably, the treatment showed robust efficacy regardless of prior omalizumab experience and maintained a favorable safety profile, with most adverse events being mild and reversible. The company is currently conducting Phase 3 trials, positioning barzolvolimab as a potential transformative treatment for CSU patients.

Celldex Therapeutics (NASDAQ:CLDX) announced upcoming presentations of Phase 2 data for barzolvolimab in chronic spontaneous urticaria at the EAACI Congress 2025 in Glasgow. The company will host a webcast on June 12th at 6:00 PM ET to discuss the findings. Two key presentations are scheduled: a late-breaking oral presentation on June 13th discussing 76-week efficacy data and sustained disease control after treatment withdrawal, and another presentation on June 14th focusing on 52-week angioedema data. The presentations will feature notable experts including Dr. Martin Metz from Charité – Universitätsmedizin Berlin and Dr. Ana Maria Giménez-Arnau. The data presentations will provide insights into the long-term efficacy and tolerability of barzolvolimab in treating chronic spontaneous urticaria.

Celldex Therapeutics (NASDAQ:CLDX) has appointed Denice M. Torres to its Board of Directors. Torres brings extensive pharmaceutical and consumer healthcare leadership experience, most notably from her tenure at Johnson & Johnson (2009-2017) where she served as Chief Strategy and Transformation Officer for the $25B medical device business and President of McNeil Consumer Healthcare. She successfully led the recovery of OTC brands including Tylenol and currently serves as CEO of The Ignited Company, a consulting firm she founded. Torres' background includes a 14-year career at Eli Lilly, board positions at multiple biotech companies, and founding The Mentoring Place, a nonprofit supporting women's career development. She holds degrees from Ball State University, Indiana University, University of Michigan, and Centenary University.