HAMPTON, N.J. - Celldex (NASDAQ:CLDX) Therapeutics, Inc. (NASDAQ:CLDX) announced today that their latest clinical trial results for a new chronic spontaneous urticaria (CSU) treatment, barzolvolimab, will be presented at the upcoming American Academy of Allergy, Asthma & Immunology Annual Meeting later this month. The phase 2 study, which assessed the drug's efficacy and safety in patients unresponsive to antihistamines, showed significant disease activity reduction at the 12-week mark.
The research, led by Marcus Maurer, M.D., from Charité - Universitätsmedizin in Berlin, will be detailed in an oral presentation on Saturday, February 24. The abstract, now available on the meeting website, includes topline results previously disclosed on November 6, 2023.
In the randomized, double-blind, placebo-controlled trial, 208 patients with moderate to severe CSU were assigned to receive varying doses of barzolvolimab or a placebo. The primary endpoint was the mean change from baseline to Week 12 in the Urticaria Activity Score over 7 days (UAS7). Secondary endpoints evaluated other safety and clinical activity measures.
Following the 16-week placebo-controlled treatment period, patients will enter a 36-week active treatment phase, with subsequent follow-up for an additional 24 weeks. The optimal dosing strategy is a key objective of this study.
Celldex is set to host a webcast presentation of the data on Sunday, February 25, accessible through the company's website. The biotechnology firm is recognized for its work at the intersection of mast cell biology and the development of therapeutics for severe inflammatory and autoimmune diseases.
Investors should note that forward-looking statements in the press release are based on current management expectations and may differ materially from actual results. These statements are subject to risks and uncertainties, including clinical trial outcomes and regulatory approvals.
This news article is based on a press release statement from Celldex Therapeutics , Inc.
InvestingPro Insights
As Celldex Therapeutics (NASDAQ:CLDX) garners attention with its promising clinical trial results for barzolvolimab, investors are considering the financial health and market performance of the company. According to InvestingPro data, Celldex holds a market capitalization of approximately 1.94 billion USD. Notably, the company's revenue has seen a remarkable surge, with a growth of 304.92% over the last twelve months as of Q3 2023.
InvestingPro Tips indicate that Celldex's financial position includes more cash than debt on its balance sheet, providing a solid liquidity stance. Additionally, the company's liquid assets exceed its short-term obligations, which is a positive sign for meeting its immediate financial responsibilities. On the other hand, analysts have revised their earnings expectations downwards for the upcoming period, and the company is not expected to be profitable this year. Despite these mixed signals, Celldex has experienced a strong return over the last three months.
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