Celldex Therapeutics (CLDX) Stock News

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.

Celldex Therapeutics (NASDAQ:CLDX) reported Q1 2025 financial results and pipeline updates. The company's lead drug barzolvolimab showed promising results in Phase 2 studies for chronic urticaria, with significant quality of life improvements for patients. Key highlights include:

- Two Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) for chronic spontaneous urticaria are ongoing, each enrolling ~915 patients

- 76-week data from Phase 2 CSU study will be presented at EAACI 2025 in June

- Phase 2 studies in eosinophilic esophagitis (enrollment complete), prurigo nodularis, and atopic dermatitis are progressing

Financial results: Q1 2025 net loss of $53.8M ($0.81/share), cash position of $673.3M. R&D expenses increased to $52.6M from $31.7M YoY. Current cash runway extends through 2027.

Celldex presented histology data from its ongoing Phase 2 study of barzolvolimab in treating eosinophilic esophagitis (EoE) at DDW 2025. The data revealed high numbers of intraepithelial mast cells in EoE patients, correlating with eosinophil counts. This supports the potential therapeutic benefit of barzolvolimab as a mast cell depleting agent. The Phase 2 "EvolvE" study is fully enrolled, with clinical results expected in 2H 2025. The trial involves a 28-week, randomized, double-blind study evaluating 300 mg of barzolvolimab versus placebo administered every 4 weeks. The primary endpoint focuses on reduction in peak esophageal epithelial mast cell count at 12 weeks. Screening data from 151 participants showed strong associations between mast cells and eosinophils, particularly in the distal esophagus, supporting the drug's potential in treating this chronic inflammatory disease.

Celldex Therapeutics (NASDAQ:CLDX) has announced its upcoming participation in two major investor conferences in March 2025. The company's management will engage in fireside chat presentations at:

• The TD Cowen 45th Annual Health Care Conference on March 4th at 1:50 p.m. ET
• The Leerink Partners Global Healthcare Conference on March 11th at 1:00 p.m. ET

Both presentations will be accessible through live webcasts on the Celldex website's 'Events & Presentations' page under the 'Investors & Media' section. Replay access will remain available for 90 days after each event.