Welcome to our dedicated page for Xbiotech news (Ticker: XBIT), a resource for investors and traders seeking the latest updates and insights on Xbiotech stock.
XBiotech Inc. develops True Human™ monoclonal antibodies derived from human donors for inflammatory, oncology, neurologic, and infectious disease applications. Company news centers on its antibody platform, Natrunix, an anti-interleukin-1alpha candidate studied in pancreatic cancer and rheumatology, and Hutrukin, a candidate therapy for reducing brain injury after ischemic stroke.
Recurring developments include clinical study results, program-prioritization decisions, FDA-related clinical authorizations, enrollment updates, and the company’s Austin campus operations, including GMP manufacturing, research laboratories, infectious disease facilities, quality control, and clinical operations.
XBiotech (NASDAQ:XBIT) announced FDA clearance to begin the Phase II V-SPINE (PT064) trial of vilamakitug in active axial spondyloarthritis. The IND completed the FDA’s 30-day review without clinical hold, allowing U.S. patient enrollment and marking the resumption of XBiotech’s rheumatology program under a leading expert advisory board.
XBiotech (NASDAQ: XBIT) announced the suspension of its rheumatology clinical program following irregularities in its Phase II study of Natrunix for Rheumatoid Arthritis. The study, which enrolled approximately 230 subjects with moderate to severe rheumatoid arthritis, failed to meet its primary endpoint of ACR20 response rate after 12 weeks. The trial evaluated Natrunix (200mg or 400mg weekly) in combination with methotrexate (MTX) against placebo with MTX.
Significant irregularities were discovered at the highest enrolling clinical sites, including multiple enrollments of the same subjects, raising concerns about data interpretation. The company has put additional planned studies in arthritis and ankylosing spondylitis on hold while evaluating these findings.
XBiotech (NASDAQ: XBIT) announced promising results from its Phase 1/2 trial for advanced pancreatic cancer treatment using Natrunix in combination with a standard chemotherapy regimen. The study, titled 1-BETTER, enrolled 65 subjects who received either the Natrunix combination or a placebo. Key findings include a 28% reduction in significant adverse events in the Natrunix group, a 33% decrease in hospitalization days, and a notable improvement in patient-reported outcomes such as reduced fatigue (22%) and pain (41%). While overall survival rates showed a trend favoring Natrunix, the small sample size led to a borderline statistical significance (p = 0.096). XBiotech emphasizes the potential of Natrunix to improve tolerability and efficacy of pancreatic cancer treatment.
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