Current Report Filing (8-k)
June 26 2018 - 4:08PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): June 26, 2018
PUMA BIOTECHNOLOGY, INC.
(Exact Name of Registrant as Specified in its Charter)
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Delaware
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001-35703
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77-0683487
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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10880 Wilshire Boulevard, Suite 2150
Los Angeles, California 90024
(Address of principal executive offices) (Zip Code)
(424)
248-6500
(Registrants telephone number, including area code)
N/A
(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:
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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 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).
Emerging growth company ☐
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. ☐
Item 8.01 Other Events.
Puma Biotechnology, Inc. (the Company) announced that the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive trend vote recommending the approval of the Marketing Authorization Application (MAA) for neratinib for the extended adjuvant treatment of early stage HER2-positive
hormone receptor positive breast cancer. The decision follows a reexamination of the negative opinion announced by the CHMP at its formal meeting with the Company to discuss the MAA on February 23, 2018. The CHMP communicated its intention to
hold a final vote at its next meeting.
Forward-Looking Statements
This Current Report on Form
8-K
contains forward-looking statements, including statements regarding the
CHMP opinion, the basis for its opinion regarding the Companys MAA, and steps the Company may take in the future to gain marketing approval in Europe. All statements other than historical facts are forwardlooking statements and are based
on the Companys current expectations, forecasts and assumptions. Forwardlooking statements involve risks and uncertainties that could cause the Companys actual results to differ materially from the anticipated results and
expectations expressed in these forward-looking statements. These risk and uncertainties are identified in the Companys Annual Report on Form
10-K
for the year ended December 31, 2017, the
Companys Quarterly Report on Form
10-Q
for the quarter ended March 31, 2018 and any subsequent documents the Company files with the Securities and Exchange Commission. Readers are cautioned not to
place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements except as required by law.
SIGNATURE
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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PUMA BIOTECHNOLOGY, INC.
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Date: June 26, 2018
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By:
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/s/ Alan H. Auerbach
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Alan H. Auerbach
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Chief Executive Officer and President
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Puma Biotechnology (NASDAQ:PBYI)
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