Welcome to our dedicated page for Celldex Therapeutics news (Ticker: CLDX), a resource for investors and traders seeking the latest updates and insights on Celldex Therapeutics stock.
Celldex Therapeutics, Inc. (NASDAQ: CLDX) is a cutting-edge biopharmaceutical company focused on developing targeted therapeutics for devastating diseases with inadequate treatment options. The company leverages a proprietary portfolio of antibodies and immunomodulators to create novel, disease-specific therapies that modify the body's immune response. Founded with the belief that harnessing the immune system's power could overcome significant barriers in drug development, Celldex has built a robust pipeline of therapeutic antibodies, antibody-drug conjugates, immune system modulators, and vaccines.
Celldex is actively engaged in clinical trials for its promising pipeline products, including Varlilumab, CDX-301, CDX-1140, CDX-0159/Anti-KIT Program (barzolvolimab), and CDX-527. These therapies target conditions like breast cancer, metastatic melanoma, lung cancer, solid tumors, and ovarian cancer, focusing on specific patient populations with high unmet medical needs.
Recently, Celldex reported positive results from its Phase 2 clinical trial of barzolvolimab in patients with chronic spontaneous urticaria (CSU), a condition unresponsive to standard antihistamines and biologics. The study demonstrated significant improvements in patient symptoms, paving the way for Phase 3 trials. Additional clinical studies are underway for barzolvolimab in chronic inducible urticaria (CIndU), prurigo nodularis (PN), and eosinophilic esophagitis (EOE).
Celldex's financial health is robust, with substantial capital to support ongoing research and development. The company's recent public offering raised significant funds, ensuring the continuation of its innovative programs through 2027. Strategic partnerships, including collaborations with renowned institutions like Rockefeller University, further bolster Celldex's research endeavors.
Celldex Therapeutics is at the forefront of biotech innovation, striving to deliver transformative treatments for severe inflammatory, allergic, autoimmune, and other debilitating diseases. Stay updated with the latest developments and news by visiting www.celldex.com.
Celldex Therapeutics (NASDAQ:CLDX) has launched its global Phase 3 program for barzolvolimab in Chronic Spontaneous Urticaria (CSU) patients. The program includes two trials, EMBARQ-CSU1 and EMBARQ-CSU2, enrolling over 1,800 patients who remain symptomatic despite antihistamine or biologic treatments. Barzolvolimab, a novel monoclonal antibody, targets the root cause of CSU by blocking the KIT receptor, essential for mast cell function. The trials will evaluate two dosing regimens against placebo over 52 weeks, with the primary endpoint assessing reduction in urticaria activity at Week 12. This advancement follows successful Phase 2 results, where barzolvolimab demonstrated rapid, durable, and clinically meaningful responses in moderate to severe CSU patients.
Celldex Therapeutics (NASDAQ: CLDX) announced its participation in the Jefferies Healthcare Conference. The management will engage in a fireside chat on June 6, 2024, at 10:00 am ET. A webcast of the presentation will be available on the Celldex website under the 'Events & Presentations' section. The session will be accessible for replay for 90 days after the event.
Celldex Therapeutics (NASDAQ:CLDX) announced significant improvements in angioedema in patients with chronic spontaneous urticaria (CSU) during a Phase 2 trial of barzolvolimab. Data revealed a rapid onset of relief within 2 weeks, sustained through 12 weeks, across various dose groups. The study included 208 participants and demonstrated clinically meaningful and statistically significant advancements in AAS7 scores, with improvements seen in patients regardless of their prior omalizumab status. The 300 mg cohort showed the highest efficacy, with a 25.32 LS mean difference from placebo. The findings, presented at the EAACI Congress 2024, suggest barzolvolimab could become an effective treatment for CSU, leading to the initiation of Phase 3 studies this summer.
Celldex Therapeutics announced the dosing of the first patient in its Phase 2 study of barzolvolimab for treating prurigo nodularis (PN). This humanized monoclonal antibody targets the KIT receptor tyrosine kinase, important for mast cell function, believed to drive chronic itch and neuroinflammation in PN. Earlier Phase 1b results showed significant clinical benefits with barzolvolimab, prompting this larger, double-blind, placebo-controlled study. The trial will assess the efficacy and safety of two dosing regimens in about 120 patients over 40 weeks, aiming to evaluate itch improvement and lesion healing. The study involves 50 global centers, including the U.S.
Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported Q1 2024 financial results and a corporate update. Phase 3 CSU studies to start in summer 2024. Positive Phase 2 CSU 12-week data presented at AAAAI 2024, with 52-week data to follow later. Phase 2 CIndU study enrollment completed, with Phase 2 PN study ongoing. Atopic dermatitis selected for Phase 2 study by YE 2024. Cash position at $823.8 million. Total revenue at $0.2 million. R&D expenses at $31.7 million. G&A expenses at $9.1 million. Net loss at $32.8 million.
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