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Celldex completes patient enrollment for Phase 2 urticaria trial

EditorNatashya Angelica
Published 04/17/2024, 12:56 PM

HAMPTON, N.J. - Celldex (NASDAQ:CLDX) Therapeutics, Inc. (NASDAQ:CLDX) has announced the completion of patient enrollment for its Phase 2 clinical trial of barzolvolimab, a treatment for chronic inducible urticaria (CIndU), including its two most common forms, cold urticaria (ColdU) and symptomatic dermographism (SD). The study aims to evaluate the efficacy and safety of the drug in patients who continue to experience symptoms despite antihistamine therapy.

The trial, which has enrolled 196 patients in two cohorts, will test multiple dose regimens of barzolvolimab over a 20-week treatment phase, followed by a 24-week follow-up. The primary endpoint is the percentage of patients with a negative provocation test at Week 12. Secondary endpoints include safety and other clinical activity assessments.

Barzolvolimab is an antibody that inhibits the activity of the receptor tyrosine kinase KIT, which is required for mast cell function. Mast cells play a key role in inflammatory responses such as hypersensitivity and allergic reactions. With no approved therapies for CIndU other than antihistamines, the company believes barzolvolimab could be a significant new treatment option.

Anthony Marucci, President and CEO of Celldex Therapeutics , expressed gratitude towards the trial participants and indicated that the company looks forward to presenting the top-line data in the second half of the year. This follows positive primary endpoint results from a similar Phase 2 study of barzolvolimab in chronic spontaneous urticaria (CSU) presented in February 2024.

CIndU is marked by hives or wheals triggered by specific stimuli, affecting approximately 0.5% of the population. ColdU involves itching and wheals when the skin is exposed to temperatures below skin temperature, while SD involves wheals in response to skin friction.

The information for this article is based on a press release statement from Celldex Therapeutics. The company continues to lead research in mast cell biology and the development of treatments for severe inflammatory and allergic diseases. Further details on the ongoing trial can be found on the clinical trials website under identifier NCT05405660.

InvestingPro Insights

As Celldex Therapeutics (NASDAQ:CLDX) progresses with its Phase 2 clinical trial for barzolvolimab, investors and stakeholders are closely monitoring the company's financial health and market performance. According to InvestingPro data, Celldex boasts a market capitalization of approximately $2.49 billion, reflecting its standing in the biopharmaceutical industry.

Despite the lack of profitability in the last twelve months, with a reported gross profit margin of -1614.53%, the company's revenue growth has been impressive, showing a surge of 192.02% over the same period.

Delving into the stock's performance, Celldex's share price has experienced a significant uptick over the last six months, with a 61.41% return, underscoring the optimistic investor sentiment surrounding the company's pipeline developments.

This optimism is further supported by the fact that two analysts have revised their earnings upwards for the upcoming period, as per InvestingPro Tips. Still, the stock's volatility remains a factor to consider, with an RSI suggesting that it is currently in oversold territory.

Investors evaluating Celldex's potential as part of their portfolio should note that the company holds more cash than debt on its balance sheet, providing a degree of financial flexibility. Additionally, its liquid assets exceed short-term obligations, which is a positive sign for the company's liquidity position.

For those interested in deeper analysis, there are over 10 additional InvestingPro Tips available, which can be accessed with the exclusive coupon code PRONEWS24 for an additional 10% off a yearly or biyearly Pro and Pro+ subscription.

As the biotech firm anticipates presenting top-line data later this year, these financial insights and metrics could be crucial for investors making informed decisions about their involvement with Celldex Therapeutics.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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