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 clinical-stage biotechnology company developing antibody-based therapies for mast cell-driven inflammatory and allergic diseases. This page provides centralized access to official press releases, financial disclosures, and third-party analysis of CLDX's progress in advancing treatments for chronic urticarias, atopic dermatitis, and other high-need conditions.
Investors and researchers will find timely updates on clinical trial milestones, regulatory submissions, and strategic collaborations. Content spans Phase 1-3 study results, peer-reviewed research highlights, and management commentary from earnings calls. All materials are sourced directly from Celldex or reputable financial/medical publications.
Key focus areas include developments for lead candidate barzolvolimab (anti-KIT antibody), bispecific antibody CDX-622, and pipeline expansion into new indications. Bookmark this page to monitor progress in mast cell biology innovation without promotional bias.
Celldex (NASDAQ:CLDX) reported Q3 2025 results and pipeline progress on Nov 10, 2025. Key clinical wins include positive Phase 2 barzolvolimab data in CSU (71% complete response at 52 weeks; >40% sustained at 76 weeks), positive Phase 2 results in ColdU and SD (complete response up to 66% and 49% vs placebo 16% and 10% at 20 weeks), and Phase 3 for ColdU/SD planned to start in Dec 2025. CDX-622 Phase 1 showed good tolerability, favorable PK, and dose-dependent serum tryptase reductions; Part 2 data expected Q3 2026. Financials: cash and marketable securities were $583.2M at Sept 30, 2025, net loss was $67.0M (Q3) and R&D spend was $62.9M (Q3). Company expects runway through 2027.
Celldex (NASDAQ: CLDX) announced on Nov 10, 2025 the appointment of Teri Lawver as Senior Vice President, Chief Commercial Officer.
Ms. Lawver brings 30 years of commercial and P&L leadership, including leadership of $4B annual revenue and 1,900 employees as Chief Commercial Officer at Dexcom, and prior global immunology roles at Johnson & Johnson. She succeeds Richard Wright, who will retire after more than a decade at Celldex. Management cited her experience with major biologic launches and immunology expertise as relevant as Celldex prepares for a potential launch of barzolvolimab and advances its pipeline.
Celldex (NASDAQ:CLDX) said management will participate in three investor conference fireside chats in November and December 2025.
Scheduled events: Guggenheim Healthcare Innovation on Nov 11, 2025 at 10:00 AM ET; Cowen Immunology & Inflammation Summit on Nov 13, 2025 at 9:30 AM ET; and Evercore Healthcare Conference on Dec 2, 2025 at 3:00 PM ET. Live webcasts will be available on the company's Investors > Events & Presentations page, with replays accessible for 90 days after each event.
Celldex (NASDAQ:CLDX) reported additional Phase 2 data showing barzolvolimab produced rapid, profound and durable control of chronic spontaneous urticaria (CSU) in a study presented at ACAAI on Nov 6, 2025.
Key results: mean UCT7 improvement up to 8.6 points vs 2.5 placebo at Week 12 and up to 10.0 points at Week 52; 71% achieved complete disease control (UCT7=16) and 86% well‑controlled (UCT7>12) at 150 mg Q4W at Week 52; sustained benefit with 7.4‑point improvement at Week 76 and 41% reporting complete response at Week 76. The Phase 2 primary endpoint (UAS7 at Week 12) was met; Phase 3 program is enrolling.
Celldex (NASDAQ:CLDX) reported Phase 2 results for barzolvolimab in cold urticaria (ColdU) and symptomatic dermographism (SD) showing sustained efficacy and a favorable safety profile over a 20‑week placebo‑controlled period.
Key findings: up to 66% (ColdU) and 49% (SD) achieved complete response at Week 20 versus 16% and 10% for placebo; up to 78% (ColdU) and 58% (SD) achieved partial or complete response versus 25% and 16% for placebo. Barzolvolimab produced marked improvements in TempTest and FricTest thresholds and itch scores. Safety over 20 weeks was favorable; most adverse events were grade 1 and reversible. A Phase 3 study is planned to start in December 2025.
Celldex (NASDAQ:CLDX) reported positive Phase 1 data for CDX-622, a bispecific antibody targeting stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP), presented Oct 30, 2025.
Key results: well tolerated in 32 healthy participants across 4 IV dose cohorts (0.3–9.0 mg/kg), no dose-limiting toxicities, no serious adverse events, no antidrug antibodies, mAb-like PK with ~18-day half-life at 9 mg/kg, and a ~50% sustained reduction in serum tryptase over 12 weeks after a single dose. NOAEL in GLP tox was the highest tested dose (75 mg/kg) with profound tissue mast cell depletion. Company advanced to multiple ascending doses and plans to report Parts 2/3 data in Q3 2026 and initiate a Phase 1b asthma study thereafter.
Celldex (NASDAQ:CLDX) presented new Phase 2 data for barzolvolimab in chronic spontaneous urticaria (CSU) at EADV Congress 2025. The drug showed rapid and sustained efficacy regardless of patients' baseline immunoglobulin E (IgE) levels.
Key findings demonstrate that barzolvolimab achieved complete response rates of up to 51% at 12 weeks, increasing to 71% at 52 weeks. Notably, 41% of patients maintained complete response even 7 months after treatment completion. The drug works by targeting mast cells through the KIT receptor, showing particular promise for patients with low IgE levels who typically have more severe disease and respond poorly to existing treatments.
The company is currently conducting two global Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) to further evaluate the drug's efficacy and safety in CSU patients who remain symptomatic despite antihistamine or biologic treatments.
Celldex Therapeutics (NASDAQ:CLDX) announced its management team will participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9th, 2025, at 3:20 pm ET.
Investors can access a live webcast of the presentation through the "Events & Presentations" page in the "Investors" section of Celldex's website. The presentation recording will remain available for 90 days after the event.
Celldex Therapeutics (NASDAQ:CLDX) announced topline results from its Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE). While the study met its primary endpoint by demonstrating significant mast cell depletion in the gastrointestinal tract, it failed to show clinical improvement in EoE symptoms compared to placebo.
The trial showed that peak mast cell counts decreased by 36.0 in the barzolvolimab arm versus 2.7 in placebo (p<0.0001). However, no definitive evidence of clinical improvement was observed in dysphagia symptoms or endoscopic scoring. Based on these results, Celldex will not advance development in EoE but continues to progress barzolvolimab in other indications, including two Phase 3 studies in chronic spontaneous urticaria and Phase 2 studies in atopic dermatitis and prurigo nodularis.
Celldex Therapeutics (NASDAQ:CLDX) reported Q2 2025 financial results and pipeline updates. The company's lead drug barzolvolimab demonstrated exceptional results in Phase 2 chronic spontaneous urticaria (CSU) studies, with up to 41% of patients maintaining complete response 7 months after treatment completion.
Financial highlights include $630.3 million in cash reserves (sufficient through 2027), Q2 net loss of $56.6 million ($0.85 per share), and increased R&D expenses of $54.2 million. The company is advancing its global Phase 3 program in CSU with two trials enrolling approximately 915 patients each.
Multiple data readouts are expected in 2H 2025, including results from Phase 2 studies in eosinophilic esophagitis (EoE) and chronic inducible urticaria (CIndU), along with Phase 1 data from CDX-622 in healthy volunteers.
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