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.
- Two Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) for chronic spontaneous urticaria are ongoing, each enrolling ~915 patients
- 76-week data from Phase 2 CSU study will be presented at EAACI 2025 in June
- Phase 2 studies in eosinophilic esophagitis (enrollment complete), prurigo nodularis, and atopic dermatitis are progressing
Financial results: Q1 2025 net loss of $53.8M ($0.81/share), cash position of $673.3M. R&D expenses increased to $52.6M from $31.7M YoY. Current cash runway extends through 2027.
Celldex Therapeutics (NASDAQ:CLDX) has announced its upcoming participation in two major investor conferences in March 2025. The company's management will engage in fireside chat presentations at:
- The TD Cowen 45th Annual Health Care Conference on March 4th at 1:50 p.m. ET
- The Leerink Partners Global Healthcare Conference on March 11th at 1:00 p.m. ET
Both presentations will be accessible through live webcasts on the Celldex website's 'Events & Presentations' page under the 'Investors & Media' section. Replay access will remain available for 90 days after each event.
Celldex Therapeutics (NASDAQ:CLDX) has presented positive preclinical data for CDX-622, their novel bispecific antibody targeting inflammatory and fibrotic disorders, at the AAAAI 2025 Annual Meeting. The antibody works by targeting both thymic stromal lymphopoietin (TSLP) and stem cell factor (SCF) pathways.
The preclinical studies demonstrated that CDX-622 effectively neutralizes both SCF and TSLP, reducing tissue mast cells and inhibiting Type 2 inflammatory responses. Key findings show the antibody inhibits inflammatory activities with similar potency to existing treatments, preferentially targets soluble SCF, and demonstrates favorable pharmacokinetic properties.
A Phase 1 study in healthy volunteers, initiated in November, is currently ongoing with initial data expected later in 2025. The compound showed strong safety profile in toxicology studies, with no adverse effects observed even at the highest dose level of 75 mg/kg.
Celldex Therapeutics (NASDAQ:CLDX) has announced positive results from Phase 2 studies of barzolvolimab in chronic urticaria patients. The drug, a humanized monoclonal antibody targeting KIT receptor, showed significant improvements in both chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) patients.
Key findings from the 52-week CSU study include:
- Up to 71% of patients achieved complete response
- 82% reported symptoms no longer impacted quality of life
- 95% reported meaningful quality of life improvement
In the 12-week CIndU study:
- 53% of ColdU and 58% of SD patients achieved complete response
- 60% reported symptoms no longer impacted quality of life
- 69% reported well-controlled urticaria
Global Phase 3 studies (EMBARQ-CSU1 and EMBARQ-CSU2) are currently enrolling, with plans to advance to Phase 3 for CIndU in 2025.
Celldex Therapeutics (NASDAQ:CLDX) reported its Q4 and full-year 2024 financial results, highlighting significant progress in its clinical programs. The company's lead drug barzolvolimab showed promising results in chronic urticarias, with Phase 3 studies actively enrolling patients globally.
Financial highlights include:
- Cash position of $725.3 million as of December 31, 2024
- Q4 2024 revenue of $1.2 million
- Full-year 2024 revenue of $7.0 million
- Q4 net loss of $47.1 million ($0.71 per share)
- Full-year net loss of $157.9 million ($2.45 per share)
The company initiated new programs including a Phase 2 study in atopic dermatitis and launched CDX-622, their first inflammatory bispecific candidate. Multiple data readouts are expected in 2025, with current cash runway extending through 2027.
Celldex Therapeutics (NASDAQ:CLDX) has initiated a Phase 2 study of barzolvolimab in atopic dermatitis (AD), a common chronic inflammatory skin disease affecting up to 20% of the US population. The study will evaluate approximately 120 patients with moderate to severe AD, randomized to receive either 150mg or 300mg of barzolvolimab or placebo every 4 weeks.
The 32-week trial includes a 16-week placebo-controlled phase followed by a 16-week active treatment phase. The primary endpoint will measure itch intensity reduction using the Peak Pruritus Numerical Rating Scale at Week 16. The study will be conducted across up to 50 clinical trial centers in the United States.
Celldex Therapeutics (NASDAQ:CLDX) has initiated dosing in its Phase 1a study of CDX-622, a bispecific antibody targeting inflammatory diseases. The study will evaluate safety, pharmacokinetics, and pharmacodynamics in up to 56 healthy volunteers. CDX-622 targets two inflammatory pathways by neutralizing TSLP and depleting mast cells via SCF starvation. The trial consists of two parts: single ascending doses and multiple ascending doses administered intravenously every 3 weeks. A subcutaneous formulation will be added to the study in 2025. The company aims to expand into asthma studies following successful completion of this trial.
Celldex Therapeutics (NASDAQ:CLDX) has announced its management's upcoming participation in two major healthcare investor conferences. The company will engage in fireside chats at the Guggenheim Healthcare Innovation Conference on November 12th at 4:00 p.m. ET and the 7th Annual Evercore HealthCONx Conference on December 3rd at 4:15 p.m. ET. Both presentations will be available via live webcasts on the company's website under the 'Events & Presentations' section, with replays accessible for 90 days after each event.