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. (NASDAQ: XBIT) is a clinical-stage biopharmaceutical company based in the United States, focused on discovering and developing True Human™ monoclonal antibodies for treating a variety of diseases. Founded on pioneering technologies in antibody research, XBiotech aims to harness the body's natural immunity to combat serious illnesses.
The company's flagship product, MABp1, is a first-in-class monoclonal antibody designed to inhibit chronic inflammation, a key factor in the progression of numerous significant diseases. MABp1 has shown promising results in clinical trials for various conditions, including cancer and leukemia (Phase I), type 2 diabetes (Phase II), psoriasis (Phase II), and vascular disease (Phase II). This antibody is unique as it remains unmodified from its natural human form, which has contributed to its excellent safety and tolerability profiles in clinical trials.
Another notable product in XBiotech's pipeline is Natrunix, currently under investigation for treating rheumatoid arthritis (RA). Natrunix works by blocking interleukin-1 (IL-1), a critical component in the inflammation process that causes pain and joint destruction in RA. A recent Phase II study involving Natrunix aims to assess its efficacy in combination with methotrexate (MTX), involving approximately 210 subjects across various clinical sites in the United States. Early findings are promising, showing significant potential for improving pain, tenderness, and mobility in joints, alongside enhancing patients' quality of life.
Hutrukin is another promising candidate in XBiotech's portfolio, aimed at minimizing brain injury following ischemic stroke. The company has recently completed enrollment for a Phase I clinical study to assess the safety and pharmacokinetics of Hutrukin. This novel antibody could potentially reduce inflammatory injuries associated with reperfusion, a common issue following stroke treatments.
XBiotech's commitment to innovation extends to its biomanufacturing capabilities. The company has invested in a commercial-scale plant featuring a total bioreactor capacity of 25,000 liters, adhering to current good manufacturing practices (cGMP). These advancements enable rapid and flexible production of therapeutic antibodies, ensuring timely delivery to patients in need.
Headquartered in Austin, Texas, XBiotech leverages cutting-edge genetic engineering tools to identify rare antibodies from human donor blood. This approach has resulted in a robust pipeline of True Human™ antibody therapies that hold potential for revolutionizing treatments for oncology, inflammatory conditions, and infectious diseases. For more information, visit www.xbiotech.com.
XBiotech Inc. (NASDAQ: XBIT) has successfully completed the Phase I portion of its 1-BETTER study assessing the anti-cancer drug Natrunix combined with chemotherapy for pancreatic cancer. Thirty leading cancer centers participated in the study, which showed that Natrunix was well-tolerated without any dose-limiting toxicities. The Phase II portion is now starting, enrolling 60 subjects to evaluate key endpoints like progression-free survival and overall survival. Pancreatic cancer remains a significant health challenge, with about 50,000 deaths expected in the U.S. in 2022.
XBiotech announced the approval of its candidate cancer treatment Natrunix by the French National Agency for the Safety of Medicines and Health Products (ANSM) for a multicenter Phase-I-III clinical study. This study aims to evaluate Natrunix in combination with trifluridine/tipiracil for treating metastatic colorectal cancer in patients who haven't responded to prior treatments. Funded by a grant from the French National Cancer Institute (INCA), the study will enroll at least 160 subjects across 20 leading medical centers in France.
XBiotech has announced a Manufacturing Agreement with Janssen Research & Development, extending its support for the production of Bermekimab until December 2023. This follows the sale of Bermekimab to Janssen in December 2019. Although contract manufacturing is not a core part of XBiotech's strategy, the company is leveraging its advanced manufacturing technology and facilities in Austin, Texas to facilitate this arrangement. XBiotech aims to use the generated revenue to further develop its pipeline of therapeutic antibodies.
XBiotech has enrolled the first patient in a randomized clinical study for Natrunix-SQ, a promising therapy targeting arthritis. The Phase I study will evaluate safety and pharmacokinetics while assessing blood levels at increasing doses. Natrunix-SQ aims to neutralize interleukin-1, a key inflammation driver, specifically targeting IL-1a, potentially redefining anti-inflammatory treatments. Following successful Phase I results, multiple Phase II studies are planned. This development marks a significant step in advancing treatments for rheumatological diseases.
XBiotech Inc. (NASDAQ: XBIT) has received FDA authorization to initiate clinical development for Natrunix, its novel True Human™ antibody therapy targeting rheumatological diseases. This breakthrough therapy aims to treat inflammatory joint diseases, including osteoarthritis and rheumatoid arthritis (RA), without causing general immunosuppression. With an increasing number of patients diagnosed—projected to rise to 67 million in the U.S. by 2030—Natrunix's Phase I study will begin with dosing for subcutaneous injections, followed by Phase II studies in RA.
XBiotech (NASDAQ: XBIT) has announced its plan to initiate a Phase I/II randomized, placebo-controlled clinical study for a new True Human™ antibody therapy aimed at reducing brain injury after stroke. The study will take place at leading U.S. medical centers and targets ischemia-reperfusion injury, a consequence of inflammation that follows the reopening of blocked arteries. With stroke contributing to high mortality and disability worldwide, this therapy could represent a significant advancement in neurology.
On September 8, 2021, XBiotech (NASDAQ: XBIT) announced Dr. Benjamin Musher will chair its clinical program for Natrunix™, a novel cancer drug targeting pancreatic cancer. This drug aims to reduce tumor growth by blocking tumor blood supply and minimizing chemotherapy toxicity. The 1-BETTER study will evaluate Natrunix™ alongside existing treatments at multiple cancer centers, generating crucial data on survival rates and quality of life for patients. John Simard, CEO, expressed optimism about the upcoming results from this promising clinical trial.
XBiotech Inc. (NASDAQ: XBIT) has appointed Dr. Mark Ziats as Medical Director, enhancing its clinical team focused on developing its drug candidates for diseases like cancer and cardiovascular conditions. Dr. Ziats brings extensive medical experience, having trained at Baylor College and the University of Cambridge. CEO John Simard emphasized that Dr. Ziats’ expertise will strengthen XBiotech’s mission of utilizing True Human antibodies, derived from individuals with natural immunity, to treat various diseases. XBiotech continues to advance its therapeutic antibody pipeline aimed at redefining standard care practices.
XBiotech has distributed a total of USD $75 million to its shareholders through a dividend of USD $2.47 per share, paid on July 23, 2021. Over the past 18 months, the company has rewarded shareholders with approximately USD $495 million via dividends and stock repurchase programs. This financial strength stems from the development of its True Human™ antibody drug pipeline, alongside cost-effective manufacturing and clinical trial practices. CEO John Simard highlighted the company's commitment to shareholder returns, emphasizing their innovative approach in the industry.
XBiotech has announced a special cash dividend of approximately $2.50 per share, totaling $75 million for shareholders, payable on July 23, 2021. This decision reflects the company’s robust financial position, featuring no debt and substantial opportunities in its drug pipeline. Shareholders must be on record by the close of business on July 16, 2021 to qualify for this one-time dividend. However, future dividends remain at the discretion of the Board, dependent on various financial considerations.
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