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 its participation in a virtual fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 16, 2022, at 1:00 p.m. ET. Senior management will represent the company during this event. Interested parties can access a webcast of the presentation via the company's 'Events & Presentations' page, with a replay available for 30 days afterward. Celldex focuses on developing monoclonal and bispecific antibodies aimed at treating severe diseases, including various cancers and inflammatory diseases.
Celldex Therapeutics (NASDAQ:CLDX) announced the first patient has been dosed in a Phase 1 study of CDX-0159 for prurigo nodularis (PN), a debilitating skin disease. This monoclonal antibody targets the KIT receptor to aid in reducing chronic itch linked to PN. The study will enroll about 40 patients divided into four groups, assessing safety and clinical effects over 8 weeks. The Chief Medical Officer highlighted the milestone's potential impact on patients suffering from PN, as there are currently no approved treatments.
Celldex Therapeutics (NASDAQ:CLDX) announced promising preclinical results for CDX-585, a bispecific antibody targeting ILT4 and PD-1 pathways, at the SITC 2021 meeting. The data indicate that CDX-585 successfully merges blockade of these checkpoints, enhancing T cell activation and demonstrating anti-tumor effects in humanized melanoma models. This marks the first advancement from a collaboration with Biosion, Inc. and supports the initiation of manufacturing and IND-enabling studies, with significant implications for immune response in cancer therapy.
Celldex Therapeutics (NASDAQ:CLDX) will participate in several virtual investor conferences in November 2021. Notable events include the Guggenheim 3rd Annual Healthcare Talks Neuro/Immunology Conference on November 16 at 10:20 a.m. ET, the Jefferies London Healthcare Conference available on-demand starting November 18 at 3:00 a.m. ET, and the Evercore ISI 4th Annual HealthCONx Conference on November 30 at 8:25 a.m. ET. Webcasts of these presentations will be accessible on the Celldex website for 30 days post-event.
Celldex Therapeutics (NASDAQ:CLDX) announced its Q3 2021 financial results, reporting a net loss of $20.5 million, or ($0.45) per share. Revenue for the quarter was $0.2 million, reflecting growth from contract manufacturing but a decline in licensing revenue. Cash remains strong at $423.1 million, supported by a $287.5 million public offering in July. The company reported positive outcomes in its Phase 1b study of CDX-0159, achieving a 95% complete response rate in chronic inducible urticaria patients, alongside promising data from multiple clinical trials across its pipeline.
Celldex Therapeutics has announced promising results from its Phase 1b trial of CDX-0159, a monoclonal antibody for treating antihistamine-refractory chronic inducible urticaria. A single dose of CDX-0159 led to rapid and sustained improvement in urticaria control and significantly enhanced quality of life for patients. Notably, 95% of patients achieved a complete response to provocation tests, with over 80% reaching a 'well controlled' status within four weeks. The data supports the potential of CDX-0159 to transform treatment for these debilitating conditions.
Celldex Therapeutics (NASDAQ:CLDX) announced participation in the 2021 Cantor Virtual Global Healthcare Conference on September 29, 2021, at 1:20 p.m. ET. Senior management will engage in a fireside chat during the event.
A webcast of the presentation will be accessible on the company's Events & Presentations page.
Celldex Therapeutics (NASDAQ:CLDX) announced that an abstract on CDX-0159's efficacy in managing symptoms of cold contact urticaria and symptomatic dermographism will be presented at the European Academy of Dermatology and Venereology 30th Congress from September 29 to October 2, 2021. The presentation highlights the antibody's rapid clinical response and quality of life improvements. Interim data available at submission in May will be updated at the event. CDX-0159 targets the KIT receptor, essential for mast cell function in chronic urticaria.
Celldex Therapeutics (NASDAQ:CLDX) announced the dosing of the first cohort in a Phase 1 study for CDX-0159, a humanized monoclonal antibody targeting receptor tyrosine kinase KIT. This subcutaneous formulation aims to support chronic urticarias treatment in a Phase 2 study set for 2022. The Phase 1 trial will assess safety and pharmacodynamics among 32 healthy volunteers across four dosing cohorts. CDX-0159 shows promise for conditions involving mast cell activation, crucial in various inflammatory diseases.
Celldex Therapeutics reported promising data from the CDX-0159 Phase 1b study in chronic inducible urticaria, revealing that 95% of patients had a complete response. The company successfully raised $287.5 million from a public offering in July 2021, financing further development of CDX-0159 and its bispecific platform. For Q2 2021, total revenues reached $3.5 million, up from $0.2 million year-over-year, while R&D expenses increased to $12.4 million. The net loss was $13.4 million, or ($0.34) per share. Celldex anticipates sufficient funds for operations through 2025.