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 (NASDAQ: XBIT) announced a $75 million payment from funds escrowed as part of its December 2019 sale of bermekimab, bringing the total received to $750 million. This True Human™ antibody treats inflammatory disorders and allows XBiotech to further develop new antibodies targeting the same inflammatory pathways. The company may also receive up to $600 million more by granting exclusivity for certain indications. XBiotech continues to manufacture and support clinical trials for bermekimab and is developing new antibodies, such as XB2001 for pancreatic cancer.
XBiotech Inc. (NASDAQ: XBIT) has commenced the 1-BETTER study, enrolling its first patient to evaluate the safety and efficacy of XB2001 in combination with chemotherapy for pancreatic cancer treatment. This double-blind, placebo-controlled trial will assess overall survival, progression-free survival, and treatment tolerability. The study will also examine a novel endpoint known as 'clinical benefit response,' focusing on muscle mass and patient-reported outcomes. Successful results could potentially enhance chemotherapy outcomes and reduce hospitalization rates.
XBiotech has announced an agreement to supply its new cancer drug XB20-01 to INSERM for use in clinical trials targeting advanced colorectal cancer. This agreement addresses the significant unmet medical need for better treatment options, as current therapies yield modest outcomes and entail considerable side effects. The lead investigator of the study, Dr. François Ghiringhelli, emphasizes the potential of XB20-01 to improve overall survival in patients. If successful, the trial could lead to a phase III expansion focused on survival improvement, thus marking a significant advancement in treatment.
XBiotech has received FDA approval to initiate clinical trials for its new drug candidate, XB2001, aimed at treating pancreatic cancer. The disease's mortality rate has been rising, with an estimated 48,220 deaths in the US this year. The trials will assess the drug's efficacy when used alongside existing treatments like ONIVYDE and 5-fluorouracil. The study is led by top oncologists and aims to improve treatment outcomes while mitigating chemotherapy-related toxicities. XBiotech aims to address the high unmet need in pancreatic cancer therapies.
XBiotech Inc. (NASDAQ: XBIT) announced its candidate True Human™ COVID-19 therapy may effectively treat the new mutant strain of the virus. The therapy targets the spike protein, which the company found it binds to with the same high affinity as the original virus. XBiotech's therapy displays potential in the face of a more contagious variant that could dominate in the U.S. soon. The company plans to enhance manufacturing to support clinical development. Its recent success with a prior antibody sale generated substantial financial resources to expand its pipeline.
XBiotech Inc. (NASDAQ: XBIT) has established its Cerebrovascular Medical Advisory Board (CMAB), chaired by Clay Johnston, M.D., Ph.D., to guide the development of a neuroprotectant therapy targeting ischemic stroke. The board includes renowned experts Greg Albers, M.D., and Brett Cucchiara, M.D. The CMAB aims to advance a True Human™ antibody therapy that may mitigate reperfusion injury, addressing a significant unmet medical need. XBiotech plans to expedite clinical development, building on its previous successful antibody sale in 2019, which generated significant revenue.
XBiotech Inc. (NASDAQ: XBIT) announced promising new data regarding its FLUVID™ therapy for treating co-infections of influenza and COVID-19. The therapy's antibodies neutralize test viruses four times more effectively than those under FDA consideration for emergency use. Research indicates a 100% survival rate in animal models given lethal flu doses. With the resurgence of COVID-19 this flu season, FLUVID™ aims to fill a critical treatment gap for patients facing these concurrent illnesses. Developed from years of research, FLUVID™ targets multiple influenza strains alongside COVID-19.
XBiotech Inc. (NASDAQ: XBIT) has announced the development of FLUVID™, a potential breakthrough therapy aimed at treating co-infections from influenza and COVID-19. As flu season approaches, FLUVID is intended to provide immunity and facilitate treatment for these dual infections. The therapy combines XBiotech’s True Human antibodies for influenza, targeting all known strains, with newly discovered COVID-19 antibodies. This integrated approach aims to harness human immunity to combat both viruses effectively.
XBiotech Inc. (NASDAQ: XBIT) has received FDA emergency use authorization for its COVID-19 Convalescent Plasma (CCP) treatment in collaboration with BioBridge Global. This test identifies antibodies from recovered COVID-19 patients, aiding the production of convalescent plasma to treat hospitalized patients. Preliminary studies indicate a 35% better survival rate for treated patients. XBiotech is also advancing its pipeline of True Human therapeutic antibodies. The company is expanding its facilities to enhance research and production capabilities.
XBiotech Inc. (NASDAQ: XBIT) announced it has identified True Human antibodies that could serve as a potential therapy against SARS-CoV2, the virus causing COVID-19. This discovery arose from collaboration with BioBridge Global, utilizing proprietary screening technology to analyze blood samples from individuals who recovered quickly from the virus. XBiotech's antibodies effectively block the virus and promote natural clearance. The company continues to expand its pipeline, including developing multiple therapeutic candidates and enhancing its manufacturing capabilities.
FAQ
What is the current stock price of XBiotech (XBIT)?
What is the market cap of XBiotech (XBIT)?
What is XBiotech's core business?
What are True Human™ antibodies?
What is MABp1?
What is Natrunix?
What is Hutrukin?
What are the potential benefits of Natrunix in RA treatment?
Where are XBiotech's operations based?
What is the significance of XBiotech's biomanufacturing facility?
Has XBiotech conducted successful clinical trials recently?
How can I get more information about XBiotech?
