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. reports developments as a clinical-stage biotechnology company focused on mast cell biology and antibody-based therapeutics for allergic, inflammatory, autoimmune and other mast cell-mediated diseases. Company updates center on barzolvolimab, a humanized monoclonal antibody being studied across chronic spontaneous urticaria, cold urticaria and symptomatic dermographism, as well as pipeline work that includes CDX-622 in asthma.
Recurring news themes include clinical data presentations at allergy and dermatology meetings, financial results, corporate updates and capital actions. Celldex also reports financing activity tied to its common stock and development priorities for its antibody-based immunology pipeline.
Celldex (Nasdaq: CLDX) on April 1, 2026 announced a proposed underwritten public offering of common stock, with underwriters granted a 30-day option to buy up to an additional 15% of offered shares.
All shares are being offered by the company; net proceeds are intended to fund commercial readiness and potential launch of barzolvolimab, ongoing clinical and preclinical development, bispecific platform growth, pipeline development, and general corporate purposes. Final terms depend on market conditions and will be disclosed in a prospectus supplement.
Celldex (NASDAQ:CLDX) presented Phase 2 data at AAD 2026 showing barzolvolimab produced rapid, profound and durable quality-of-life improvements in chronic spontaneous urticaria (CSU), cold urticaria (ColdU) and symptomatic dermographism (SD).
Key results: up to 51% complete response at Week 12 (CSU), 71% at Week 52, 41% maintained response seven months off therapy; ColdU/SD complete responses reached up to 66% and 49% at Week 20. DLQI domain scores improved across all six domains with many patients achieving DLQI 0/1.
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.