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 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.
Celldex Therapeutics (NASDAQ:CLDX) has launched its global Phase 3 program for barzolvolimab in Chronic Spontaneous Urticaria (CSU) patients. The program includes two trials, EMBARQ-CSU1 and EMBARQ-CSU2, enrolling over 1,800 patients who remain symptomatic despite antihistamine or biologic treatments. Barzolvolimab, a novel monoclonal antibody, targets the root cause of CSU by blocking the KIT receptor, essential for mast cell function. The trials will evaluate two dosing regimens against placebo over 52 weeks, with the primary endpoint assessing reduction in urticaria activity at Week 12. This advancement follows successful Phase 2 results, where barzolvolimab demonstrated rapid, durable, and clinically meaningful responses in moderate to severe CSU patients.
Celldex Therapeutics (NASDAQ: CLDX) announced its participation in the Jefferies Healthcare Conference. The management will engage in a fireside chat on June 6, 2024, at 10:00 am ET. A webcast of the presentation will be available on the Celldex website under the 'Events & Presentations' section. The session will be accessible for replay for 90 days after the event.
Celldex Therapeutics (NASDAQ:CLDX) announced significant improvements in angioedema in patients with chronic spontaneous urticaria (CSU) during a Phase 2 trial of barzolvolimab. Data revealed a rapid onset of relief within 2 weeks, sustained through 12 weeks, across various dose groups. The study included 208 participants and demonstrated clinically meaningful and statistically significant advancements in AAS7 scores, with improvements seen in patients regardless of their prior omalizumab status. The 300 mg cohort showed the highest efficacy, with a 25.32 LS mean difference from placebo. The findings, presented at the EAACI Congress 2024, suggest barzolvolimab could become an effective treatment for CSU, leading to the initiation of Phase 3 studies this summer.