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 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.
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.