XBIOTECH INC. (NASDAQ:XBIT) Files An 8-K Other Events
Item 8.01 Other Events.

CHMP Opinion

On May 18, 2017, XBiotech Inc. (the “Company”) announced that it has received a negative opinion from the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) for its Marketing Authorization Application for its lead product candidate in Europe.

The Company plans to promptly notify the EMA of its request for a re-examination and will have 60 days to submit its grounds for appeal. The Company firmly believes it has a strong position for re-examination.

This Form 8-K contains forward-looking statements, including declarations regarding management’s beliefs and expectations, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “would,” “could,” “expects,” “plans,” “contemplate,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “intend” or “continue” or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in "Risk Factors" in our SEC filings.

About XBIOTECH INC. (NASDAQ:XBIT)

XBiotech Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in discovering and developing True Human monoclonal antibodies for treating a range of diseases. The Company focuses on bringing its lead product candidate, Xilonix (MABp1), to market. The Company has also developed a True Human monoclonal antibody discovery platform and manufacturing system. The Company’s therapeutic antibody Xilonix is being evaluated as a monotherapy to treat advanced stages of colorectal cancer. Xilonix neutralizes a pro-inflammatory protein produced by leukocytes and other cells, interleukin-1 alpha (IL-1a). The Company completed a Phase I and II clinical trial for MABp1 as a treatment for cancer at MD Anderson Cancer Center. The Company is also investigating MABp1 in clinical trials for other indications, including vascular disease, type II diabetes, acne and psoriasis.

XBIOTECH INC. (NASDAQ:XBIT) Recent Trading Information

XBIOTECH INC. (NASDAQ:XBIT) closed its last trading session down -0.13 at 8.82 with 98,092 shares trading hands.