Current Report Filing (8-k)
July 05 2017 - 7:02AM
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): June 14, 2017
NEUROCRINE BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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0-22705
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33-0525145
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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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12780 El Camino Real, San Diego, California
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92130
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code:
(858) 617-7600
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 June 14, 2017, Neurocrine Biosciences, Inc. (the
Company) submitted a supplemental New Drug Application (the Supplemental NDA) with the U.S. Food and Drug Administration (the FDA) for the approval of 80 mg capsules of INGREZZA
®
(valbenazine) for the treatment of tardive dyskinesia. As previously disclosed, on April 11, 2017, the FDA approved 40 mg capsules of INGREZZA for the treatment of tardive dyskinesia.
Pending notification of the acceptance by the FDA of the Supplemental NDA, the Company has been advised that the PDUFA goal date is October 14, 2017.
In accordance with General Instruction B.2 of
Form 8-K, the
information in this Current
Report on
Form 8-K
shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act) or otherwise subject to the
liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Forward-Looking Statements
Statements
contained in this Current Report on Form
8-K
regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, the risks and uncertainties the Company faces include risks
that the Supplemental NDA may not obtain regulatory approval from the FDA, or such approval may be delayed or conditioned; risks that additional regulatory submissions may not occur or be submitted in a timely manner; risks that the FDA or
regulatory authorities outside the U.S. may make adverse decisions regarding INGREZZA; risks that ongoing INGREZZA development activities may be delayed for regulatory or other reasons; risks that INGREZZA may infringe upon the proprietary rights of
third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with the Companys dependence on third parties for development, manufacturing and distribution activities related to INGREZZA; risks and
uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; and other risks described in the Companys annual report on Form
10-K.
The Company disclaims
any obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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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Dated: July 5, 2017
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NEUROCRINE BIOSCIENCES, INC.
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/s/ Darin M. Lippoldt
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Darin M. Lippoldt
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Chief Legal Officer
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