Celldex Initiates Global Registrational Phase 3 Program of Barzolvolimab in Cold Urticaria and Symptomatic Dermographism

HAMPTON, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today the initiation of its global Phase 3 trial (EMBARQ-ColdU and SD) designed to establish the efficacy and safety of barzolvolimab in adult patients with cold urticaria (ColdU) and symptomatic dermographism (SD) who remain symptomatic despite H1 antihistamine treatment. ColdU and SD are characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival.

GlobeNewsWire • Dec 9, 2025

Celldex Announces Appointment of Teri Lawver as Chief Commercial Officer

HAMPTON, N.J., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ: CLDX) today announced the appointment of Teri Lawver as Senior Vice President, Chief Commercial Officer. Ms. Lawver is an accomplished global healthcare executive with 30 years of strategic, commercial launch and operating P&L leadership across the biopharmaceutical, medical device and consumer health technology sectors. Ms. Lawver succeeds Richard Wright, who will retire from Celldex following more than a decade of dedicated leadership and service.

GlobeNewsWire • Nov 10, 2025

Celldex to Present at Upcoming Investor Conferences

HAMPTON, N.J., Nov. 07, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today that management will participate in fireside chats at the following upcoming investor conferences:

GlobeNewsWire • Nov 7, 2025

Celldex Presents Data Demonstrating Barzolvolimab Improves Chronic Spontaneous Urticaria Independent of Baseline Immunoglobulin E levels in Phase 2 Study at EADV Congress 2025

Rapid and sustained efficacy regardless of baseline IgE levels in patients with CSU Rapid and sustained efficacy regardless of baseline IgE levels in patients with CSU

GlobeNewsWire • Sep 17, 2025

Celldex Therapeutics, Inc. (CLDX) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference Transcript

Celldex Therapeutics, Inc. (NASDAQ:CLDX ) Morgan Stanley 23rd Annual Global Healthcare Conference September 9, 2025 3:20 PM EDT Company Participants Anthony S. Marucci - Founder, President, CEO & Director Tibor Keler - Founder, Chief Scientific Officer & Executive VP Diane Young - Senior VP & Chief Medical Officer Conference Call Participants Judah Frommer - Morgan Stanley, Research Division Presentation Judah Frommer Equity Analyst Welcome, everyone, to this session of the Morgan Stanley Global Healthcare Conference.

Seeking Alpha • Sep 10, 2025

Celldex to Present at Morgan Stanley 23rd Annual Global Healthcare Conference

HAMPTON, N.J., Sept. 09, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced that management will participate in a fireside chat today, September 9th, 2025, at the Morgan Stanley 23rd Annual Global Healthcare Conference at 3:20 pm ET. A live webcast of the presentation will be available on the "Events & Presentations” page of the "Investors" section of the Celldex website. A replay will be available for 90 days following the event.

GlobeNewsWire • Sep 9, 2025

Celldex: Despite Dropping Eosinophilic Esophagitis Program, Barzolvolimab On Track

Celldex Therapeutics, Inc.'s barzolvolimab failed to improve symptoms in eosinophilic esophagitis, but this setback doesn't impact its promising ongoing urticaria programs. Phase 3 trials for chronic spontaneous urticaria are underway, with additional studies for chronic inducible urticaria set to begin soon in 2nd half of 2025. The global urticaria market size is projected to reach $11.4 billion by 2032.

Seeking Alpha • Aug 21, 2025

Celldex Therapeutics Pulls Plug On Eosinophilic Esophagitis Investigational Drug As Data Falls Short

On Tuesday, Celldex Therapeutics, Inc. CLDX released topline results from its ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus.

Benzinga • Aug 20, 2025

Celldex Reports Results from Phase 2 Study of Barzolvolimab in Eosinophilic Esophagitis (EoE)

HAMPTON, N.J., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported topline results from the Company's ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus. Identifying the key drivers of EoE has challenged the field and research has suggested that mast cells could play an important role in the disease pathogenesis. Celldex designed this study to determine if barzolvolimab could deplete mucosal (intraepithelial) mast cells and, in turn, improve clinical outcomes in EoE. The primary endpoint of the study, absolute change from baseline to Week 12 in peak esophageal intraepithelial mast cell count was met, but the profound mast cell depletion observed did not result in improvement in EoE symptoms or endoscopic assessment of disease activity compared to placebo. Consistent with previously reported studies, barzolvolimab demonstrated a favorable safety and tolerability profile. Based on these results, Celldex will not advance development in EoE. The results do support future development with KIT- or SCF-targeted therapies in other GI indications where mucosal mast cells are believed to play an important role.

GlobeNewsWire • Aug 19, 2025

Celldex Reports Second Quarter 2025 Financial Results and Provides Corporate Update

HAMPTON, N.J., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the second quarter ended June 30, 2025 and provided a corporate update.

GlobeNewsWire • Aug 7, 2025