UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 28, 2015

(Commission File Number)

(512) 386-2900

(Registrant’s telephone number, including area code)

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01 Other Events.

On May 28, 2015, XBiotech Inc. (the "Company"), announced that the Food and Drug Administration (FDA) has lifted its clinical hold from the Company’s IND, enabling the launch of its Phase 1/2 study of an investigational therapy for S. aureus infections. XBiotech was placed on clinical hold by the FDA while it worked with the agency to prepare its therapy and manufacturing process for human studies. XBiotech will now begin enrollment of approximately 52 patients in a Phase 1/2 randomized, placebo-controlled, dose escalation study, which will evaluate safety and efficacy of its therapy to treat serious S. aureus infections.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.