Celldex Therapeutics Inc Stock Price, News & Analysis

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.

Celldex Therapeutics (NASDAQ:CLDX) has presented positive preclinical data for CDX-622, their novel bispecific antibody targeting inflammatory and fibrotic disorders, at the AAAAI 2025 Annual Meeting. The antibody works by targeting both thymic stromal lymphopoietin (TSLP) and stem cell factor (SCF) pathways.

The preclinical studies demonstrated that CDX-622 effectively neutralizes both SCF and TSLP, reducing tissue mast cells and inhibiting Type 2 inflammatory responses. Key findings show the antibody inhibits inflammatory activities with similar potency to existing treatments, preferentially targets soluble SCF, and demonstrates favorable pharmacokinetic properties.

A Phase 1 study in healthy volunteers, initiated in November, is currently ongoing with initial data expected later in 2025. The compound showed strong safety profile in toxicology studies, with no adverse effects observed even at the highest dose level of 75 mg/kg.

Celldex Therapeutics (NASDAQ:CLDX) has announced positive results from Phase 2 studies of barzolvolimab in chronic urticaria patients. The drug, a humanized monoclonal antibody targeting KIT receptor, showed significant improvements in both chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) patients.

Key findings from the 52-week CSU study include:

• Up to 71% of patients achieved complete response
• 82% reported symptoms no longer impacted quality of life
• 95% reported meaningful quality of life improvement

In the 12-week CIndU study:

• 53% of ColdU and 58% of SD patients achieved complete response
• 60% reported symptoms no longer impacted quality of life
• 69% reported well-controlled urticaria

Global Phase 3 studies (EMBARQ-CSU1 and EMBARQ-CSU2) are currently enrolling, with plans to advance to Phase 3 for CIndU in 2025.