Met primary endpoint demonstrating clinically meaningful and statistically significant complete response rate across both dose groupsFirst large, randomized, placebo-controlled study to demonstrate success in CIndU Favorable safety and tolerability consistent with prior studies Plans to advance CIndU into Phase 3 registration developmentCompany to host webcast call today at 4:30 pm ET HAMPTON, N.J., July 29, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive topline r ...

Clinical Trial Results - Barzolvolimab demonstrated clinically meaningful and statistically significant complete response rates across both dose groups in the Phase 2 clinical trial for chronic inducible urticaria (CIndU) [1] - The study is the first large, randomized, placebo-controlled trial to show success in treating CIndU, specifically cold urticaria (ColdU) and symptomatic dermographism (SD) [1] - Barzolvolimab achieved the primary efficacy endpoint, with 46.9% (150 mg q4w) and 53.1% (300 mg q8w) of ColdU patients showing a negative provocation test at Week 12, compared to 12.5% for placebo [3] - For SD patients, 57.6% (150 mg q4w) and 42.4% (300 mg q8w) achieved a negative provocation test at Week 12, compared to 3.2% for placebo [3] Safety and Tolerability - Barzolvolimab exhibited a favorable safety profile consistent with prior studies, with most adverse events being mild to moderate in severity [3] - The most common treatment-emergent adverse events were hair color changes (13%) and neutropenia (11%) [3] - The rate of infections was similar between barzolvolimab-treated patients and placebo, with no association between neutropenia and infections [3] Study Design and Methodology - The Phase 2 study was a randomized, double-blind, placebo-controlled trial involving 196 patients with CIndU who remained symptomatic despite antihistamine therapy [4] - Patients were divided into two cohorts: 97 with ColdU and 99 with SD, and were randomized to receive barzolvolimab at 150 mg every 4 weeks, 300 mg every 8 weeks, or placebo [4] - The primary endpoint was the percentage of patients with a negative provocation test at Week 12, assessed using TempTest® for ColdU and FricTest® for SD [4][5] Future Development - The company plans to advance barzolvolimab into Phase 3 registration development for CIndU [1] - Full 12-week data from the study will be presented at a medical meeting in the fourth quarter of 2024 [2] About Chronic Inducible Urticaria (CIndU) - CIndU is characterized by hives or wheals triggered by specific stimuli, such as cold temperatures in ColdU or skin scratching/rubbing in SD [7] - Approximately 0.5% of the population suffers from chronic inducible urticarias, with mast cell activation being a key driver of symptoms [7] - There are currently no approved therapies for CIndU other than antihistamines, and patients often manage symptoms by avoiding triggers [7] About Barzolvolimab - Barzolvolimab is a humanized monoclonal antibody that binds and inhibits the receptor tyrosine kinase KIT, which is critical for mast cell function and survival [8] - It is being studied in multiple indications, including chronic spontaneous urticaria (CSU), prurigo nodularis (PN), and eosinophilic esophagitis (EOE), with plans for additional indications like atopic dermatitis (AD) [8] Company Overview - Celldex Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapeutics for severe inflammatory, allergic, and autoimmune diseases [9] - The company’s pipeline includes antibody-based therapeutics targeting mast cell biology and other critical pathways [9]

- EMBARQ-CSU1 and EMBARQ-CSU 2 will enroll more than 1800 patients suffering from CSU -- Studies include both biologic naïve and experienced patients - HAMPTON, N.J., July 16, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today the initiation of its global Phase 3 program, consisting of two Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatme ...

HAMPTON, N.J., June 04, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in a fireside chat at the Jefferies Healthcare Conference on Thursday, June 6th at 10:00 am ET. A webcast of the presentation will be available on the "Events & Presentations” page of the "Investors & Media" section of the Celldex website. A replay will be available for 90 days following the event. About Celldex Therapeutics, Inc.Celldex is a clinical stage biotechnology ...

Shares of Celldex Therapeutics (CLDX) have gained 1.7% over the past four weeks to close the last trading session at $36.92, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $69.14 indicates a potential upside of 87.3%.The mean estimate comprises seven short-term price targets with a standard deviation of $20.15. While the lowest estimate of $27 indicates a 26.9% decline from the ...

HAMPTON, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company's Phase 2 subcutaneous study of barzolvolimab in prurigo nodularis (PN). 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 the function and survival of the mast cell. Mast cells are believed to play an important role i ...

Shares of Celldex Therapeutics (CLDX) have gained 5.2% over the past four weeks to close the last trading session at $41.21, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $69.14 indicates a potential upside of 67.8%.The mean estimate comprises seven short-term price targets with a standard deviation of $20.15. While the lowest estimate of $27 indicates a 34.5% decline from the ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 000-15006 CELLDEX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware No. 13-3191702 (State or other jurisdiction of incorporat ...

EXHIBIT 99.1 Celldex Reports First Quarter 2024 Financial Results and Provides Corporate Update - Phase 3 CSU studies expected to initiate in summer 2024 - - Positive Phase 2 CSU 12 week data reported in late breaking oral presentation at AAAAI 2024; 52 week data to be reported in 2H 2024 - - Enrollment completed in Phase 2 CIndU study; 12 week data expected 2H 2024 - - Phase 2 PN study initiated; enrollment progressing in Phase 2 EoE study - - Atopic dermatitis selected as next indication; Phase 2 study to ...

- Phase 3 CSU studies expected to initiate in summer 2024 -- Positive Phase 2 CSU 12 week data reported in late breaking oral presentation at AAAAI 2024; 52 week data to be reported in 2H 2024 -- Enrollment completed in Phase 2 CIndU study; 12 week data expected 2H 2024 -- Phase 2 PN study initiated; enrollment progressing in Phase 2 EoE study -- Atopic dermatitis selected as next indication; Phase 2 study to initiate by YE 2024 - HAMPTON, N.J., May 06, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (N ...