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 (CLDX) has priced a public offering of 5,952,381 shares at $42.00 each, with gross proceeds expected to be around $250 million. The offering includes an option for underwriters to purchase an additional 892,857 shares. The funds will support clinical and preclinical development of product candidates like CDX-0159 and enhance the bispecific antibody platform. The deal is set to close on July 16, 2021, pending standard conditions. This offering follows a shelf registration statement initially filed in 2020.
Celldex Therapeutics (Nasdaq: CLDX) announced a proposed underwritten public offering of $175 million in common stock, with an additional $26.25 million option for underwriters. Proceeds will fund the clinical and preclinical development of product candidates and general corporate needs. The final offering terms will depend on market conditions. Jefferies, SVB Leerink, Guggenheim Securities, and Cantor are managing the offering. The offering is conducted under a previously filed SEC registration statement.
Celldex Therapeutics (NASDAQ:CLDX) has reported promising results from its ongoing Phase 1b clinical trial of CDX-0159, a monoclonal antibody targeting chronic inducible urticaria. All 19 patients who received the treatment showed a clinical response, with a 95% complete response rate. The median duration of response was over 77 days for cold urticaria and 57 days for symptomatic dermographism. The drug demonstrated a favorable safety profile, with common mild side effects. Celldex aims to expand treatment studies into prurigo nodularis and other mast cell-related conditions later in 2021.
Celldex Therapeutics (NASDAQ:CLDX) announced preliminary results from its Phase 1 trial of CDX-527, a bispecific antibody targeting advanced malignancies. Presented at ASCO 2021, the data include 11 patients in dose escalation cohorts ranging from 0.03 to 3 mg/kg. Key findings show CDX-527 has a favorable safety profile, with no serious adverse events or dose-limiting toxicities. Notably, pharmacodynamic activity indicates immune system engagement. The trial continues with plans for higher dose cohorts and further evaluations in 2022.
Celldex Therapeutics (NASDAQ:CLDX) announced that the abstract detailing Phase 1b results of CDX-0159 for treating antihistamine refractory cold contact urticaria and symptomatic dermographism has been accepted for presentation at the EAACI Annual Congress 2021, scheduled for July 10-12, 2021. The late-breaking electronic Poster Discussion Session will include a pre-recorded presentation followed by a Q&A. Results will highlight disease activity reduction and treatment's effect on tryptase levels.
Celldex Therapeutics (NASDAQ:CLDX) announced participation in the Jefferies 2021 Virtual Healthcare Conference on June 2, 2021, at 1:30 p.m. ET. Senior management will engage in a fireside chat during the event. Interested parties can access the webcast through the Events & Presentations page on their website. A replay of the chat will be available for 30 days post-event.
Celldex Therapeutics (NASDAQ:CLDX) reported Q1 2021 financial results, highlighting positive interim data from the Phase 1b study of CDX-0159, which showed an 80% complete response rate in chronic inducible urticaria. The company is expanding the study to include cholinergic urticaria and plans to present more results this summer. Total revenue was $0.7 million, down from $2.7 million in the prior year, while R&D expenses increased to $12.7 million. Net loss for Q1 was $16.5 million, representing a loss of $0.42 per share. Celldex expects sufficient cash to fund operations through 2023.
Celldex Therapeutics (Nasdaq:CLDX) presented promising data on its bispecific platform at the AACR Annual Meeting 2021. The focus was on ILT4 inhibitory monoclonal antibodies for developing bispecific antibodies that counter myeloid cell suppression and activate T-cell responses. Preclinical studies demonstrated the efficacy of these antibodies in enhancing immune response against tumors. The company aims to advance bispecific candidates targeting ILT4 and PD-(L)1, with existing programs such as CDX-527 undergoing clinical trials.
Celldex Therapeutics (NASDAQ:CLDX) reported significant advances in their clinical pipeline during the fourth quarter and year ended December 31, 2020. The Phase 1b study of CDX-0159 in chronic inducible urticaria showed an 80% complete response rate, prompting an expansion to include cholinergic urticaria patients. Financial highlights included a net loss of $21.9 million for Q4 2020, though total revenue increased to $3.8 million, driven by milestone payments. The company maintains a robust cash position with $194.4 million to support operations through 2023.
Celldex Therapeutics (NASDAQ:CLDX) announced interim data from its clinical trial of CDX-0159, aimed at treating antihistamine refractory cold contact urticaria and symptomatic dermographism. Out of 10 patients assessed after treatment, 80% achieved a complete response, indicating a significant efficacy of the drug. CDX-0159 was generally well tolerated, with mild infusion reactions reported. Plans to expand the study to include cholinergic urticaria are underway, and upcoming results from related studies are anticipated.