Current Report Filing (8-k)
July 26 2017 - 4:07PM
Edgar (US Regulatory)
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): July 20, 2017
ARQULE, INC.
(Exact Name of Issuer as Specified in Charter)
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Delaware
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000-21429
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04-3221586
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(State or other jurisdiction
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(Commission File Number)
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(I.R.S. Employer
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of incorporation)
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Identification No.)
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One Wall Street
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Burlington, MA
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(Address of principal executive
offices)
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(781) 994-0300
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(Registrant's telephone
number, including area code)
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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 (
see
General Instruction A.2. below):
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¨
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Written communications pursuant to Rule 425 under
the Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)
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Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
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¨
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Emerging
growth company
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If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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Item 1.01
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Entry into a Material Definitive Agreement.
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On July 20, 2017, ArQule, Inc. (“ArQule”
or the “Registrant”) entered in to a master services agreement and two separate statements of work thereunder (together,
the “Agreement”) with ARUP Laboratories Inc. (“ARUP”).
Pursuant to the terms of the Agreement,
ARUP has agreed to develop a FGFR2 FISH assay to be used as an investigational use only patient selection diagnostic in connection
with ArQule’s planned registrational Phase 3 trial with derazantinib (ARQ 087), its pan-FGFR inhibitor, in patients with
intrahepatic cholangiocarcinoma harboring FGFR2 fusions. ARUP has also agreed to further validate and seek U.S. Food and Drug Administration
approval of such assay as a companion diagnostic for commercialization in the U.S. if the aforementioned Phase 3 trial is positive
and derazantinib and the companion diagnostic assay are approved by the FDA.
The foregoing description of the material
terms of the Agreement is qualified in its entirety by reference to the full text of the Agreement which will be filed as an exhibit
to the Company's Form 10-Q for the quarter ending September 30, 2017.
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.
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ARQULE, INC.
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(Registrant)
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/s/ Peter S. Lawrence
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Peter S. Lawrence
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President and Chief Operating Officer
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July 26, 2017
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