XBIOTECH INC. (NASDAQ:XBIT) Files An 8-K Other Events
Item 8.01 Other Events.
Outcome of EMA Oral Explanation Meeting
On April 20, 2017, XBiotech Inc. (the Company) issued a press
release announcing the outcome of its Oral Explanation meeting
(OE) to discuss its Day 180 List of Outstanding Issues related to
the Companys Marketing Authorization Application submission for
its lead product candidate in Europe. The Company reported that
the European Medicines Agency (EMA) rendered a negative trend
vote after the meeting, making a positive Committee for Medicinal
Products for Human Use (CHMP) opinion unlikely. At the OE the
Company gave a 20 minute presentation and had a QA session with
CHMP members per standard meeting protocol.
A copy of the press release issued in connection with the
announcement is filed as Exhibit 99.1 to this Current Report on
Form 8-K. A copy of the presenation is filed as Exhibit 99.2 to
this Current Report on Form 8-K.
This Form 8-K and the related press release contain
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.
Item 9.01 Financial Statements and
Exhibits.
(d) Exhibits
|
Exhibit Number |
Description | |
| 99.1 | Press Release of XBiotech Inc., Issued April 20, 2017. | |
| 99.2 | Oral Explanation Presentation Slides |
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 -0.15 at 17.02 with 221,137 shares trading hands.
