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HAMPTON, N.J. - Celldex Therapeutics (NASDAQ:CLDX), a clinical-stage biotech with a market capitalization of $1.58 billion, reported Thursday that its experimental drug barzolvolimab demonstrated sustained efficacy and tolerability over 20 weeks in patients with two common forms of chronic inducible urticaria (CIndU). Despite the positive clinical news, InvestingPro data shows the stock has taken a significant 8.73% hit over the last week, though it maintains a strong 28.97% gain over the past six months.
The randomized, placebo-controlled study involving 196 patients with cold urticaria (ColdU) and symptomatic dermographism (SD) met all primary and secondary endpoints with statistical significance, according to data presented at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting in Orlando.
Results showed up to 66% of ColdU patients and 49% of SD patients achieved complete response with barzolvolimab compared to 16% and 10% on placebo, respectively. Partial or complete responses were seen in up to 78% of ColdU patients and 58% of SD patients versus 25% and 16% on placebo.
The drug demonstrated marked improvement in critical temperature thresholds for ColdU patients and friction thresholds for SD patients compared to placebo over the treatment period.
Barzolvolimab, which targets the receptor tyrosine kinase KIT required for mast cell function, was well-tolerated with most adverse events being mild. The most common side effects were hair color changes (18%) and neutropenia (12%), which was transient with no associated infections.
"Barzolvolimab is the first drug to achieve success in a large, randomized, placebo-controlled study in chronic inducible urticaria," said Diane C. Young, Senior Vice President and Chief Medical Officer at Celldex, in the press release statement.
CIndU affects approximately 0.5% of the total population, with patients experiencing hives and itching triggered by specific stimuli such as cold temperatures or skin friction. Currently, antihistamines are the only approved treatments.
Celldex plans to initiate a Phase 3 study for these indications in December 2025.
In other recent news, Celldex Therapeutics announced positive data for its treatment barzolvolimab, which showed significant improvements in urticaria control in patients with chronic spontaneous urticaria. The data was presented at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting. Additionally, Celldex reported favorable results from a Phase 1 study of its bispecific antibody CDX-622, which demonstrated a favorable pharmacokinetic profile in healthy volunteers. Mizuho initiated coverage on Celldex with an Outperform rating, citing the potential of barzolvolimab in treating mast-cell mediated diseases. Conversely, Barclays initiated coverage with an Underweight rating, expressing concerns about limited upside potential through the end of 2026. H.C. Wainwright reiterated a Buy rating for Celldex with a price target of $42.00, following Novartis's FDA approval for remibrutinib, a treatment for chronic spontaneous urticaria. These developments provide a multifaceted view of Celldex's current position in the pharmaceutical landscape.
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