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HAMPTON, N.J. - Celldex Therapeutics (NASDAQ:CLDX), a biotechnology company with a market capitalization of $1.63 billion and strong cash position according to InvestingPro data, announced Wednesday new data showing its experimental drug barzolvolimab demonstrated rapid and strong efficacy in patients with chronic spontaneous urticaria (CSU) regardless of their baseline immunoglobulin E (IgE) levels.
The findings, presented at the EADV Congress 2025, showed similar improvements in patients with both low and normal/high IgE levels, suggesting the drug could potentially treat all CSU patients regardless of their disease subtype. The company’s stock, currently trading at $24.58, has shown resilient performance with a 20.79% return over the past six months.
Barzolvolimab targets mast cells by binding to the receptor tyrosine kinase KIT, inhibiting its activity which is necessary for mast cell function and survival. The company noted this mechanism could be particularly important for patients with low IgE levels, who typically have more severe disease and respond less effectively to existing IgE-targeted therapies.
According to the data presented, patients in both IgE subgroups showed similar improvements in weekly urticaria activity scores at weeks 12 and 52. The drug also demonstrated comparable rates of well-controlled disease and complete disease control across both patient groups.
Celldex previously reported that its Phase 2 study met its primary endpoint, showing significant improvement in urticaria activity compared to placebo at 12 weeks across all dose groups. The company reported complete response rates (no itch/no hives) in up to 51% of patients at 12 weeks, increasing to 71% after 52 weeks of treatment.
The company is currently enrolling patients in two global Phase 3 trials designed to establish the efficacy and safety of barzolvolimab in adults with CSU who remain symptomatic despite antihistamine treatment, including those who haven’t responded to biologics. With analyst price targets ranging from $30 to $90, InvestingPro subscribers can access detailed financial analysis and 12 additional ProTips about CLDX’s market position and growth potential through the comprehensive Pro Research Report.
CSU is characterized by recurring hives lasting six weeks or longer without identifiable triggers, with symptoms that can persist for years or decades. Current treatments provide only symptomatic relief for some patients. Based on InvestingPro’s Fair Value analysis, CLDX is currently trading near its Fair Value, with a strong financial health score of 2.14, indicating FAIR market positioning.
The information in this article is based on a company press release statement.
In other recent news, Celldex Therapeutics has faced significant developments regarding its drug candidate barzolvolimab. The company announced that the drug failed to demonstrate clinical efficacy in treating eosinophilic esophagitis (EoE), leading to the decision to halt further development for this indication. Despite this setback, Stifel reiterated its Buy rating with a price target of $58.00, highlighting the drug’s ability to achieve mast cell depletion. Similarly, Cantor Fitzgerald maintained an Overweight rating and set a price target of $67.00, even though the trial results did not show clinical improvement in symptoms. Canaccord Genuity adjusted its price target to $62.00 from $64.00 while maintaining a Buy rating, citing the discontinuation of the EoE program. H.C. Wainwright also lowered its price target to $42.00, attributing the change to the removal of EoE from potential indications and adjustments to the share count. Wells Fargo reduced its price target to $38.00, maintaining an Overweight rating, and projected a possible decline in share price following the trial results. These developments underscore the impact of the EoE trial outcomes on Celldex’s strategic direction and investor outlook.
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