Celldex Therapeutics, Inc - CLDX STOCK NEWS

Celldex Therapeutics reported third-quarter 2022 financial results, revealing a net loss of $26.8 million, or $0.57 per share. The company had $323.5 million in cash assets, a decrease from the previous quarter. Revenue for Q3 was $0.4 million, down from $0.7 million in the same period last year. Significant clinical advancements include the initiation of Phase 2 studies for barzolvolimab, with promising early data showing symptom improvements in chronic urticaria patients. The company expects ongoing data releases and has plans for new bispecific antibody trials in 2023.

Celldex Therapeutics (NASDAQ:CLDX) announced positive interim results from the Phase 1b study of barzolvolimab in chronic spontaneous urticaria, showing significant symptom relief. The Phase 2 studies for chronic urticaria have commenced. Financially, total revenue dropped to $0.2 million in Q2 2022, down from $3.5 million in Q2 2021. R&D expenses surged to $20.7 million, influenced by clinical trial costs, while G&A expenses increased due to higher legal costs. The net loss reached $36.0 million, or ($0.77) per share. Despite the losses, the company maintains sufficient cash to fund operations through 2025.

Celldex Therapeutics (NASDAQ:CLDX) has commenced a Phase 2 clinical trial for barzolvolimab, targeting chronic inducible urticaria (CIndU), specifically cold urticaria and symptomatic dermographism. This double-blind, placebo-controlled study involves 180 patients and aims to assess the efficacy and safety of varied dosing regimens over 20 weeks. Preliminary Phase 1b data showed promising results, suggesting potential for significant improvement in treatment options for patients suffering from these conditions.

Celldex Therapeutics (NASDAQ:CLDX) has reported interim data from its ongoing Phase 1b trial of barzolvolimab, specifically targeting patients with moderate to severe chronic spontaneous urticaria (CSU). The study indicated a mean reduction in urticaria activity score (UAS7) of 66.6% at the 1.5 mg/kg dose and 75.1% at 3 mg/kg. A complete response (UAS7=0) was achieved by 57.1% and 44.4% of patients respectively. Notably, barzolvolimab exhibited a favorable safety profile, reinforcing its potential for Phase 2 studies.

Celldex Therapeutics (NASDAQ:CLDX) has initiated a Phase 2 clinical trial for barzolvolimab to treat chronic spontaneous urticaria (CSU), with the first patient dosed on June 21, 2022. This monoclonal antibody targets the receptor tyrosine kinase KIT and aims to provide new therapeutic options for CSU patients suffering from debilitating symptoms. The randomized study will include approximately 168 participants comparing different doses of barzolvolimab against a placebo over 16 weeks, followed by a 36-week treatment phase.

Celldex Therapeutics (NASDAQ:CLDX) announced the appointment of Cheryl L. Cohen and Dr. Garry Neil to its Board of Directors on June 16, 2022. Their extensive backgrounds in the pharmaceutical and biotechnology sectors are expected to support the company's clinical and corporate objectives. Cohen, previously Chief Commercial Officer of Medivation, brings commercialization experience, while Dr. Neil has held pivotal roles at various biotech firms and offers deep scientific expertise. This leadership addition aims to bolster Celldex's strategy as it advances its therapeutic pipeline.

Celldex Therapeutics (NASDAQ:CLDX) announced that its senior management will participate in a fireside chat at the 2022 Jefferies Global Healthcare Conference on June 8, 2022, at 8:30 a.m. ET in New York City. This event will provide insights into the company's advancements in monoclonal and bispecific antibodies aimed at treating severe diseases.

A webcast of the presentation will be accessible on the Investors & Media section of the Celldex website, with a replay available for 30 days afterward.

Celldex Therapeutics (NASDAQ:CLDX) announced the acceptance of an abstract detailing the Phase 1b study of barzolvolimab (CDX-0159) for patients with antihistamine refractory chronic spontaneous urticaria (CSU). This late-breaking electronic poster presentation will occur at the EAACI Annual Congress 2022 from July 1-3, 2022. The study aims to evaluate the safety and efficacy of multiple ascending doses in 40 patients who continue to experience symptoms despite antihistamine treatment. Results will include findings from various dosage cohorts.

Celldex Therapeutics (NASDAQ:CLDX) reported its Q1 2022 financial results, highlighting a net loss of $23.1 million ($0.49 per share), up from a loss of $16.5 million in Q1 2021. Total revenue decreased to $0.2 million from $0.7 million due to reduced services under agreements with Rockefeller University and Gilead Sciences. R&D expenses rose to $17.1 million, and G&A expenses increased to $6.9 million. The company remains on track with its clinical programs, including the Phase 1b study of barzolvolimab for chronic spontaneous urticaria, with a Phase 2 initiation expected this quarter.