Current Report Filing (8-k)
April 19 2017 - 6:03AM
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): April 17, 2017
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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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).
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. ☐
On April 17, 2017, Puma Biotechnology, Inc. (the
Company) announced that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for neratinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on
May 24, 2017. Neratinib is an investigational therapy for the extended adjuvant treatment of early stage HER2-positive breast cancer that has previously been treated with a trastuzumab containing regimen.
ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for
use in the treatment of cancer and makes appropriate recommendations to the FDA. Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA solely, and the
recommendations by the panel are
non-binding.
The Company announced on September 20, 2016
that the FDA had accepted for filing the NDA for neratinib. The NDA for neratinib is based on results from both the Phase III ExteNET trial in extended adjuvant early stage HER2-positive breast cancer and the Phase II CONTROL trial in extended
adjuvant early stage HER2-positive breast cancer.
Forward-Looking Statements
This Current Report on Form
8-K
contains forward-looking statements, including statements regarding the
ODACs scheduled review of the NDA for neratinib. All forward-looking statements included in this Current Report on Form
8-K
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 statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ
materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing, the Companys dependence on PB272, which is still under
development and may never receive regulatory approval, the challenges associated with conducting and enrolling clinical trials, the risk that the results of clinical trials may not support the Companys drug candidate claims, even if approved,
the risk that physicians and patients may not accept or use the Companys products, the Companys reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates, the Companys dependence
on licensed intellectual property, and the other risk factors disclosed in the periodic and current reports filed by the Company with the Securities and Exchange Commission from time to time, including the Companys Annual Report on Form
10-K
for the year ended December 31, 2016. 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: April 18, 2017
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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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