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 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.
Celldex Therapeutics (NASDAQ:CLDX) announced positive Phase 2 clinical trial results for barzolvolimab in treating chronic inducible urticaria (CIndU). The study met all primary and secondary endpoints with high statistical significance in patients with cold urticaria and symptomatic dermographism who were unresponsive to antihistamines. The trial demonstrated significant improvements in both 150mg and 300mg dosing groups compared to placebo, with up to 53.1% of cold urticaria patients and 57.6% of symptomatic dermographism patients achieving complete response. The drug showed a favorable safety profile, with mostly Grade 1 adverse events. The company plans to advance to Phase 3 development in 2025.
Celldex Therapeutics (NASDAQ:CLDX) announced upcoming presentation of 12-week results from their Phase 2 clinical trial of barzolvolimab in chronic inducible urticaria (CIndU). The study focused on two common forms: cold urticaria and symptomatic dermographism. The presentation, titled 'Positive Efficacy and Favorable Safety of Barzolvolimab in Chronic Inducible Urticaria: Phase 2 Trial Results,' will be delivered as a late-breaking oral presentation at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting in Boston on October 26th, 2024.
Celldex Therapeutics (NASDAQ:CLDX) presented 52-week results from their Phase 2 study of barzolvolimab in chronic spontaneous urticaria (CSU) at EADV 2024. Key findings include:
- 71% of patients on 150 mg Q4W achieved complete response at Week 52
- Rapid and durable improvement in UAS7 starting Week 1
- Robust improvement across omalizumab-experienced/refractory/naïve patients
- Well-tolerated safety profile through 52 weeks
The study met its primary endpoint with significant UAS7 improvement across all dose groups. Barzolvolimab targets mast cells by binding to KIT receptor, inhibiting mast cell function and survival. Global Phase 3 CSU trials are now enrolling patients.
Celldex Therapeutics (NASDAQ:CLDX) has announced that 52-week results from their Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) will be presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. The study includes patients refractory to antihistamines and biologic treatments. The presentation, titled 'Barzolvolimab shows profound efficacy and favorable safety over 52 weeks in patients with Chronic Spontaneous Urticaria,' will be given by Dr. Martin Metz on September 25th. Additionally, an e-Poster showcasing 12-week data on quality of life improvements will be available at the congress.
Celldex Therapeutics (NASDAQ:CLDX) has announced its management's participation in two upcoming investor conferences. The company will engage in fireside chats at the following events:
- 2024 Cantor Global Healthcare Conference on Tuesday, September 17th at 8:35 a.m. ET
- TD Cowen's Chronic Urticaria Summit on Friday, September 20th at 10:00 a.m. ET
Live webcasts of these presentations will be accessible on the 'Events & Presentations' page of the 'Investors & Media' section on Celldex's website. Replays will remain available for 90 days after each event, providing investors with extended access to the company's insights and updates.
Celldex Therapeutics (NASDAQ:CLDX) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
- Initiation of Phase 3 CSU studies in July 2024
- Positive topline Phase 2 CIndU 12-week data reported in July 2024
- Ongoing enrollment in Phase 2 PN and EOE studies
- Planned initiation of Phase 2 AD study by year-end 2024
- CDX-622, first bispecific for inflammatory diseases, to enter clinic this year
Financial results:
- Cash position: $802.3 million as of June 30, 2024
- Q2 2024 revenue: $2.5 million
- Q2 2024 net loss: $35.8 million ($0.54 per share)
Celldex believes its current cash position is sufficient to fund operations through 2027.
Celldex Therapeutics (NASDAQ:CLDX) announced positive topline results from their Phase 2 clinical trial of barzolvolimab in chronic inducible urticaria (CIndU). The study met its primary endpoint, demonstrating a statistically significant difference in the percentage of patients with a negative provocation test compared to placebo at Week 12. Barzolvolimab showed rapid, durable, and clinically meaningful responses in patients with CIndU refractory to antihistamines.
Key findings include:
- 46.9% and 53.1% complete response rates for cold urticaria at 150mg q4w and 300mg q8w doses, respectively
- 57.6% and 42.4% complete response rates for symptomatic dermographism at 150mg q4w and 300mg q8w doses, respectively
- Favorable safety profile with most adverse events being mild to moderate
Celldex plans to advance barzolvolimab into Phase 3 registration development for CIndU.
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