CLDX - Earnings announcements

Study met primary endpoint demonstrating barzolvolimab's ability to potently deplete mast cells in the gastrointestinal tractProfound mast cell depletion did not result in improved clinical outcomes providing direct evidence that mast cells are not a primary driver in EoE Favorable safety profile demonstrated for barzolvolimab 300 mg Q4 weekly dosing regimenCompany to host webcast today at 4:30 pm ET 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

Seven months after the completion of dosing: 41% of patients (150 mg Q4W) continue to experience complete response (UAS7=0)48% of patients (150 mg Q4W) report that CSU no longer impacts their quality of life (DLQI=0/1)KIT related tolerability events demonstrated to be reversible Enrollment to Phase 3 CSU trials ongoingCompany to host webcast today at 6:00 pm ET HAMPTON, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today new data demonstrating profound, sustained complete response and improved quality of life at 76 weeks, 7 months after the completion of dosing with barzolvolimab in chronic spontaneous urticaria (CSU), an immune-related condition driven by mast c

First to demonstrate clinical benefit in patients with chronic inducible urticaria (CIndU) in large, randomized, placebo-controlled study Favorable safety and tolerability Plan to advance CIndU into Phase 3 developmentCompany to host webcast call Monday at 8:00 am ET HAMPTON, N.J., Oct. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive results from the Company's Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). The study includes patients who remain symptomatic despite treatment with antihistamines. Barzolvolimab is a humaniz

- 71% of patients (150 mg Q4W) achieved complete response at Week 52 -- Rapid, profound and durable improvement in UAS7 as early as Week 1 with a deepening of response over 52 weeks -- Robust improvement across omalizumab-experienced/refractory/naïve disease -- Well tolerated through 52 weeks -- Enrollment to Global Phase 3 CSU trials underway -- Company to host webcast today at 12:00 pm ET/6:00 pm CEST - HAMPTON, N.J., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today new data demonstrating sustained and deepening disease efficacy and a well tolerated safety profile over a 52 week treatment period for barzolvolimab in chronic spontaneous

- Primary and secondary endpoints met with clinically meaningful and statistically significant decreases in urticaria disease activity across multiple dose groups -- Sustained activity with rapid onset within 2 weeks -- Similar improvement in omalizumab-experienced/refractory and omalizumab-naïve disease consistent with unique mechanism of action -- Favorable safety profile -- 52 week results and Phase 3 CSU trial initiations anticipated in 2024 -- Company to host webcast February 25th at 9:45 am ET- HAMPTON, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive 12 week results from the Company's Phase 2 clinical trial of barzolvolim

-Barzolvolimab met primary endpoint with clinically meaningful and statistically significant decreases in urticaria disease activity across multiple dose groups--Mean change from baseline to week 12 in UAS7 of -23.87 in 300 mg q8w dose group and -23.02 in 150 mg q4w dose group--Barzolvolimab was generally well tolerated with a favorable safety profile--Treatment will continue to 52 weeks; results support further development of barzolvolimab in Phase 3 CSU studies-- Company to host webcast call today at 8:00 am ET- HAMPTON, N.J., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive topline results from the Company's Phase 2 clinical trial of

- Response observed as early as week 1 and durable for up to 16 weeks -- Data support important role for mast cells in the pathogenesis of PN and potentially other chronic itch indications -- Phase 2 PN study to initiate in early 2024 -- Conference call to be held on Monday, November 6th at 8:00 am ET to discuss study results - HAMPTON, N.J., Nov. 05, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data from the Company's Phase 1b 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 requi

- 100% complete response rate in cold urticaria after single dose of barzolvolimab at 1.5 mg/kg, including in omalizumab refractory patients -- Long term follow up of patients with chronic inducible urticaria treated at 3.0 mg/kg confirm that barzolvolimab-induced responses and mast cell suppression are durable and linked -- Company to host webcast conference call on Tuesday, December 6 at 8:00 a.m. ET - HAMPTON, N.J., Dec. 06, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced new data from the Company's open label Phase 1b clinical trial of barzolvolimab in patients with antihistamine refractory chronic inducible urticarias are being presented at the GA²LE

- Includes oral presentation for 1.5 mg/kg cold urticaria cohort - - Company to host webcast conference call on Tuesday, December 6 at 8:00 am ET - HAMPTON, N.J., Dec. 02, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that multiple presentations from the barzolvolimab development program will be presented at the 6th GA2LEN Global Urticaria Forum (GUF) being held December 7-8 in Berlin, Germany. Abstracts will be available on the meeting website on December 6th. Presentations at GUF 2022 are outlined below and include new data from both the Phase 1b 1.5 mg/kg cohort conducted in cold urticaria and long term follow data from the Phase 1b 3.0 mg/kg cohor

-Rapid, profound and durable responses across multiple dosing groups with favorable safety profile--Mean reduction from baseline in urticaria activity (UAS7) of 66.6% in 1.5 mg/kg dose group at week 12 and 75.1% at week 8 in the 3 mg/kg dose group (reflects one dose; ongoing)--Complete response (UAS7=0) of 57.1% in 1.5 mg/kg dose group at week 12 and 44.4% at 8 weeks in 3 mg/kg dose group (reflects one dose; ongoing)--42% of patients treated with barzolvolimab had prior omalizumab and had similar symptom improvement as overall population--Company to host webcast conference call on Thursday, June 30 at 6:30 p.m. ET- HAMPTON, N.J., June 30, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc

HAMPTON, N.J., Feb. 22, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced it will host a conference call and webcast on Monday, February 28, 2022 at 4:30 p.m. ET to discuss its fourth quarter and full year 2021 financial results and corporate highlights. To access a live or recorded webcast of the call, please visit the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (United States) or (760) 298-5103 (international). The conference call passcode is 2177774. About Celldex Therapeutics, Inc.Celldex is a clinical stage biotechnol