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.
- 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.