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) generates frequent news as it advances antibody-based therapies in immunology, with a particular emphasis on mast cell–driven diseases. Company updates often center on barzolvolimab, a humanized monoclonal antibody targeting the KIT receptor on mast cells, and CDX-622, a bispecific antibody that neutralizes thymic stromal lymphopoietin (TSLP) and depletes mast cells via stem cell factor (SCF) starvation.
News coverage for Celldex commonly includes clinical trial milestones across multiple indications. For barzolvolimab, the company reports data from Phase 2 studies in chronic spontaneous urticaria (CSU) and chronic inducible urticarias such as cold urticaria (ColdU) and symptomatic dermographism (SD), describing statistically significant improvements in urticaria activity scores, provocation tests and quality-of-life measures, along with favorable safety profiles. Investors and clinicians can also follow announcements about the global Phase 3 EMBARQ-CSU program in CSU and the registrational Phase 3 EMBARQ-ColdU and SD program in ColdU and SD.
Additional Celldex news items highlight expansion of the barzolvolimab program into prurigo nodularis and atopic dermatitis, as well as strategic decisions such as discontinuing development in eosinophilic esophagitis (EoE) after a Phase 2 study showed mast cell depletion without clinical benefit. Updates on CDX-622 provide insight into early-stage safety, pharmacokinetics and pharmacodynamics, including sustained reductions in serum tryptase in healthy volunteers.
Corporate news may feature quarterly financial results, leadership appointments and participation in healthcare and investor conferences. For readers tracking CLDX, this news stream offers a view into Celldex’s progress in mast cell biology, the evolution of its clinical pipeline and key regulatory and financial disclosures. Bookmarking this page allows ongoing access to company-issued press releases and related market-relevant developments.
Celldex (NASDAQ:CLDX) presented Phase 2 open‑label extension data at AAAAI 2026 showing that barzolvolimab retreatment produces rapid, profound efficacy similar to initial exposure in Cold urticaria (ColdU) and symptomatic dermographism (SD). In the OLE, complete response rates at Week 20 were 62% (ColdU) and 60% (SD), consistent with initial study results. Among prior complete responders, repeat complete response reached 82% (ColdU) and 86% (SD). Retreatment improved control (up to 68–69% well controlled) and was well tolerated. A global Phase 3 EMBARQ trial (NCT07266402) is enrolling.
Celldex (NASDAQ:CLDX) presented Phase 2 data at AAAAI (Feb 27, 2026) showing durable clinical benefit with barzolvolimab in CSU, ColdU and symptomatic dermographism. Key results: up to 71% complete response at 52 weeks in CSU, sustained off-treatment responses (up to 41% at 7 months), and enrollment of 1,939 patients in global Phase 3 CSU.
ColdU/SD data showed up to 66% (ColdU) and 49% (SD) complete response at Week 20 with marked QoL gains.
Celldex (NASDAQ:CLDX) reported Q4 and full-year 2025 results and a clinical update. Cash and marketable securities were $518.6M at year-end; net loss was $258.8M for 2025. Enrollment completed in Phase 3 CSU (1,939 patients) six months early; topline CSU data expected Q4 2026 with a planned BLA in 2027.
Multiple 2026 readouts expected across barzolvolimab Phase 2 and 3 programs and CDX-622 early clinical data; company states cash runway through 2027.
Celldex (NASDAQ:CLDX) completed enrollment in its global Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 studies of barzolvolimab, randomizing 1,939 patients across 43 countries and >500 sites, six months ahead of guidance. Topline data are expected in Q4 2026 with a BLA planned for 2027. The trials test two dosing regimens versus placebo with the primary endpoint of UAS7 at Week 12 and primary analysis when the placebo-controlled portion completes at Week 24.
Celldex (NASDAQ:CLDX) will present multiple Phase 2 barzolvolimab datasets at the AAAAI Annual Meeting in Philadelphia, Feb 27–Mar 2, 2026. Presentations cover chronic spontaneous urticaria (CSU), cold urticaria (ColdU) and symptomatic dermographism (SD), including a late-breaker OLE retreatment analysis.
Key items include poster sessions on Feb 27 (Posters 072 and 075) and a late-breaking poster (L41) on Mar 1 showing rapid symptom control after retreatment; all presentations will be posted on the company website at the listed dates and times.
Celldex (NASDAQ:CLDX) announced management will participate in three upcoming investor conferences in February–March 2026, with live webcasts and 90-day replays available.
Events include Guggenheim Emerging Outlook: Biotech Summit on Feb 11 at 3:30 pm ET, TD Cowen Health Care on Mar 4 at 9:10 am ET, and Leerink Global Healthcare on Mar 10 at 3:40 pm ET.
Celldex (NASDAQ:CLDX) initiated EMBARQ-ColdU and SD, a global randomized Phase 3 program testing barzolvolimab in adults with cold urticaria (ColdU) and symptomatic dermographism (SD) who remain symptomatic despite H1 antihistamines.
The study will enroll ~240 participants across ~75 sites in 7 countries, randomized 1:1 to barzolvolimab (450 mg loading, then 150 mg Q4W) or placebo for 24 weeks; primary endpoint is complete response at Week 12 by TempTest® (ColdU) or FricTest® (SD). Phase 2 met all primary and secondary endpoints with rapid, durable responses and a well-tolerated safety profile.
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.