GUF

Celldex Reports Fourth Quarter and Year End 2022 Financial Results and Provides Corporate Update

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Tuesday, February 28, 2023

HAMPTON, N.J., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2022 and provided a corporate update.

Key Points: 
  • HAMPTON, N.J., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2022 and provided a corporate update.
  • Celldex believes her deep background in drug development strongly complements the current Board’s skills and experiences.
  • Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity.
  • The litigation settlement related loss had a ($0.32) impact on net loss per share for the twelve months ended December 31, 2022.

Celldex Therapeutics Presents Positive Data from Barzolvolimab Phase 1b Study in Chronic Inducible Urticaria at Global Urticaria Forum 2022

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Tuesday, December 6, 2022

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 GA²LEN Global Urticaria Forum (GUF) held in Berlin, Germany. These diseases, which are often severe and debilitating, can significantly impact patients’ lives. Barzolvolimab is a humanized monoclonal antibody that binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity.All 9 of 9 (100%) cold urticaria patients who received a 1.5 mg/kg single full dose of barzolvolimab experienced a complete response as assessed by provocation testing, including 4 of 4 patients with omalizumab refractory disease. This cohort was added to the Phase 1b trial in patients with chronic inducible urticaria after Celldex previously reported a 95% complete response rate in July 2021 in patients with antihistamine-refractory cold urticaria and symptomatic dermographism who received a single 3.0 mg/kg dose of barzolvolimab.

Key Points: 
  • 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 GA²LEN Global Urticaria Forum (GUF) held in Berlin, Germany.
  • A randomized, double-blind, placebo-controlled, multi-dose Phase 2 subcutaneous study of barzolvolimab is currently enrolling patients with both cold urticaria and symptomatic dermographism.
  • Cold Urticaria 1.5 mg/kg intravenous cohort oral presentation: “Cold urticaria patients achieve complete response with 1.5 mg/kg barzolvolimab”
    10 patients received a single intravenous infusion of barzolvolimab at 1.5 mg/kg.
  • Additional Presentations: Encore presentations reviewing previously presented data from the Phase 1b study in chronic spontaneous urticaria and on wound healing are also being presented at GUF.

Celldex Therapeutics Announces Multiple Upcoming Presentations of Barzolvolimab Data at GA²LEN Global Urticaria Forum (GUF) 2022

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Friday, December 2, 2022

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.

Key Points: 
  • 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 cohorts conducted in cold urticaria and symptomatic dermographism.
  • The chronic spontaneous urticaria (CSU) and wound healing presentations are Encore presentations and do not include new data.
  • The event will be webcast live and can be accessed by going to the "Events & Presentations" page under the "Investors & Media section of the Celldex Therapeutics website at www.celldex.com .
  • Celldex is a clinical stage biotechnology company dedicated to developing monoclonal and bispecific antibodies that address devastating diseases for which available treatments are inadequate.