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HAMPTON, N.J. - Celldex Therapeutics (NASDAQ:CLDX) on Thursday announced new exploratory endpoint data demonstrating barzolvolimab's ability to improve urticaria control in patients with chronic spontaneous urticaria (CSU). The clinical-stage biotech company, with a market capitalization of $1.58 billion, has seen its stock price drop 8.73% over the past week to $23.73, according to InvestingPro data.
The data, presented at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting in Orlando, showed significant improvements in the urticaria control test over seven days (UCT7) scores among patients receiving the treatment.
Patients on barzolvolimab experienced up to an 8.6-point improvement from baseline UCT7 scores compared to 2.5 points for placebo at Week 12. This improvement increased to 10.0 points at Week 52, according to the company.
At the 150 mg Q4W dose, 71% of patients achieved complete disease control and 86% achieved well-controlled disease at Week 52. The company noted that meaningful clinical benefit continued beyond the active treatment period, with a 7.4-point improvement observed at Week 76, seven months after the last dose.
The treatment showed similar activity across both omalizumab naïve and omalizumab refractory CSU patients. Barzolvolimab was reported to be well tolerated with no new safety findings during the follow-up period.
The Phase 2 study previously met its primary endpoint of significant improvement in UAS7 (weekly urticaria activity score) compared to placebo at 12 weeks across all dose groups tested.
Celldex is currently enrolling patients in a global Phase 3 Program for barzolvolimab in CSU, consisting of two trials designed to establish the efficacy and safety of the treatment in adult patients who remain symptomatic despite H1 antihistamine treatment, including those who remain symptomatic after treatment with biologics.
The information in this article is based on a company press release statement.
In other recent news, Celldex Therapeutics announced positive results from its Phase 1 study of the bispecific antibody CDX-622. The study demonstrated that CDX-622 was well tolerated among healthy volunteers and exhibited a favorable pharmacokinetic profile with a serum half-life of approximately 18 days at a 9 mg/kg dose level. Meanwhile, Celldex also reported new data on its experimental drug barzolvolimab, which showed strong efficacy in patients with chronic spontaneous urticaria (CSU), regardless of their baseline immunoglobulin E (IgE) levels. This suggests potential treatment applicability for all CSU patients, irrespective of disease subtype.
In terms of analyst coverage, Mizuho initiated coverage on Celldex with an Outperform rating and a price target of $48.00, highlighting the potential of barzolvolimab in mast-cell mediated diseases. Conversely, Barclays initiated coverage with an Underweight rating and a $25.00 price target, citing concerns about limited upside potential through year-end 2026. H.C. Wainwright reiterated a Buy rating with a price target of $42.00, following the FDA approval of Novartis's remibrutinib for CSU. These developments reflect a mix of optimism and caution among analysts regarding Celldex's future prospects.
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