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Xbiotech - XBIT STOCK NEWS

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. (XBIT) is a clinical-stage biopharmaceutical pioneer developing True Human monoclonal antibodies to combat chronic inflammatory diseases. This page serves as the definitive source for verified company news, including clinical trial progress, regulatory updates, and strategic initiatives.

Investors and researchers will find timely updates on mabp1 development across multiple therapeutic areas: oncology, metabolic disorders, and inflammatory conditions. Our curated news feed covers essential updates including phase trial results, manufacturing advancements at CGMP facilities, and partnerships shaping therapeutic innovation.

Key content categories include press releases on clinical milestones, financial disclosures, patent filings, and scientific presentations. Bookmark this page to monitor XBiotech's progress in advancing unmodified antibody therapies with potential safety advantages over engineered alternatives.

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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.

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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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XBiotech Inc. (XBIT) plans to expand its campus headquarters with a new state-of-the-art research and development facility in Austin, Texas. The company has received approval to begin excavation for site preparation, with groundwork expected to start in the 1st quarter of 2024. The new facility will support commercialization plans for the company’s Natrunix rheumatology program and will include clinical and medical operations, commercialization teams, and wet laboratories for ongoing infectious disease programs. The construction will also feature a subterranean parking garage to minimize ecological impact. President and CEO John Simard expressed excitement about the project, highlighting its potential to enhance operational capability and create a leading biotechnology facility in Texas.
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XBiotech (NASDAQ: XBIT) Announces Alan Kivitz M.D. as Lead Investigator for Natrunix Clinical Research Program in Rheumatoid Arthritis
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XBiotech Inc. is developing Hutrukin as a breakthrough therapy to reduce brain injury after stroke. The Phase I study aims to evaluate safety and pharmacokinetics of Hutrukin in healthy volunteers. Hutrukin may reduce inflammatory injuries associated with reperfusion, providing a unique and major advance for stroke victims.
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XBiotech completes enrollment of Phase II portion of 1-BETTER study for Natrunix in combination with chemotherapy for treating pancreatic cancer.
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XBiotech Inc. has initiated a randomized, open-label, placebo-controlled clinical study for Hutrukin, a novel therapy aimed at reducing brain injury from ischemic stroke. With over 10 million cases of ischemic strokes annually, the need for effective treatments is critical. Hutrukin seeks to mitigate reperfusion injury, a common complication following clot-removal procedures, by targeting inflammation before blood flow is restored. The Phase I study will evaluate three dosing levels for safety and pharmacokinetics, with results guiding further research phases. XBiotech leverages its proprietary True Human™ antibody technology to explore innovative treatments across various diseases.

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3.42%
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