<SEC-DOCUMENT>0001193125-18-045640.txt : 20180214
<SEC-HEADER>0001193125-18-045640.hdr.sgml : 20180214
<ACCEPTANCE-DATETIME>20180214161641
ACCESSION NUMBER:		0001193125-18-045640
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20180214
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20180214
DATE AS OF CHANGE:		20180214

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			NEUROCRINE BIOSCIENCES INC
		CENTRAL INDEX KEY:			0000914475
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				330525145
		STATE OF INCORPORATION:			CA
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-22705
		FILM NUMBER:		18612441

	BUSINESS ADDRESS:	
		STREET 1:		12780 EL CAMINO REAL
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92130
		BUSINESS PHONE:		(858) 617-7600

	MAIL ADDRESS:	
		STREET 1:		12780 EL CAMINO REAL
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92130
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>d553580d8k.htm
<DESCRIPTION>FORM 8-K
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<HTML><HEAD>
<TITLE>Form 8-K</TITLE>
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 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:14pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT
STYLE="white-space:nowrap">8-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>CURRENT
REPORT </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Pursuant to Section&nbsp;13 or 15(d) </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>of the Securities Exchange Act of 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Date of Report (Date of the earliest event reported): February&nbsp;14, 2018 </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>NEUROCRINE BIOSCIENCES, INC. </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact name of registrant as specified in its charter) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:8pt" ALIGN="center">


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<TD VALIGN="top" ALIGN="center"><B>Delaware</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">0-22705</FONT></B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">33-0525145</FONT></B></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(State or other jurisdiction</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>of incorporation or organization)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Commission</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>File Number)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(IRS Employer</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Identification No.)</B></P></TD></TR>
</TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="center"><B>12780 El Camino Real, San Diego, California</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>92130</B></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="top" ALIGN="center"><B>(Address of principal executive offices)</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>(Zip Code)</B></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Registrant&#146;s telephone number, including area code:
<FONT STYLE="white-space:nowrap">(858)&nbsp;617-7600</FONT> </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>N/A </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Former name or former address, if changed since last report.) </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Check the appropriate box below if the Form <FONT STYLE="white-space:nowrap">8-K</FONT> filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions: </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top">Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425) </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top">Soliciting material pursuant to <FONT STYLE="white-space:nowrap">Rule&nbsp;14a-12</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.14a-12)</FONT> </TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to <FONT STYLE="white-space:nowrap">Rule&nbsp;14d-2(b)</FONT> under the Exchange Act (17 CFR
<FONT STYLE="white-space:nowrap">240.14d-2</FONT> (b)) </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to <FONT STYLE="white-space:nowrap">Rule&nbsp;13e-4(c)</FONT> under the Exchange Act (17 CFR
<FONT STYLE="white-space:nowrap">240.13e-4</FONT> (c)) </TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (&#167;230.405 of this chapter) or Rule <FONT STYLE="white-space:nowrap">12b-2</FONT> of the Securities Exchange Act of 1934 <FONT STYLE="white-space:nowrap">(&#167;240.12b-2</FONT> of
this chapter). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Emerging growth company&nbsp;&nbsp; &#9744; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">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&nbsp;13(a) of the Exchange Act. &nbsp;&nbsp;&#9744; </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>

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<TD WIDTH="9%" VALIGN="top" ALIGN="left"><B>Item&nbsp;8.01</B></TD>
<TD ALIGN="left" VALIGN="top"><B>Other Events. </B></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On February&nbsp;14, 2018, Neurocrine Biosciences, Inc. (the
&#147;Company&#148;) issued a press release announcing that the U.S. Food and Drug Administration (the &#147;FDA&#148;) has provided guidance on the regulatory path forward to support the New Drug Application (&#147;NDA&#148;) for opicapone, an
investigational drug for Parkinson&#146;s disease, after receiving meeting minutes from the January 2018 meeting with the FDA. The FDA has not requested that the Company conduct an additional Phase III study for opicapone prior to the NDA filing. As
a result, the Company will proceed with plans to file the NDA for opicapone during the first half of 2019. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">In accordance with General
Instruction B.2 of <FONT STYLE="white-space:nowrap">Form&nbsp;8-K,&nbsp;the</FONT> information in this Item 8.01 and Exhibit 99.1 of this Current Report on <FONT STYLE="white-space:nowrap">Form&nbsp;8-K,</FONT> shall not be deemed &#147;filed&#148;
for purposes of Section&nbsp;18 of the Securities Exchange Act of 1934, as amended (the &#147;Exchange Act&#148;), 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 (the &#147;Securities Act&#148;), or the Exchange Act, except as expressly set forth by specific reference in such a filing. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I>Special Note Regarding Forward-Looking Statements </I></B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">This Current Report on Form <FONT STYLE="white-space:nowrap">8-K</FONT> contains &#147;forward-looking statements&#148; within the meaning of
Section&nbsp;27A of the Securities Act and Section&nbsp;21E of the Exchange Act. These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause the Company&#146;s actual results,
performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as
&#147;may&#148;, &#147;will&#148;, &#147;should&#148;, &#147;could&#148;, &#147;would&#148;, &#147;expects&#148;, &#147;plans&#148;, &#147;anticipates&#148;, &#147;believes&#148;, &#147;estimates&#148;, &#147;projects&#148;, &#147;predicts&#148;,
&#147;potential&#148; and similar expressions intended to identify forward-looking statements. These statements reflect the Company&#146;s current views with respect to future events and are based on assumptions and subject to risks and
uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, these forward-looking statements represent the Company&#146;s estimates and assumptions only as of the date of this Current
Report on Form <FONT STYLE="white-space:nowrap">8-K.</FONT> </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="9%" VALIGN="top" ALIGN="left"><B>Item&nbsp;9.01</B></TD>
<TD ALIGN="left" VALIGN="top"><B>Financial Statements and Exhibits. </B></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">(d) Exhibits. </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1.00pt solid #000000; width:25.30pt; display:inline; font-size:8pt; font-family:Times New Roman; " ALIGN="center"><B>No.</B></P></TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; width:39.50pt; display:inline; font-size:8pt; font-family:Times New Roman; "><B>Description</B></P></TD></TR>


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<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d553580dex991.htm">Press Release of Neurocrine Biosciences, Inc., dated February&nbsp;14, 2018 </A></TD></TR>
</TABLE>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">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. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" COLSPAN="3">NEUROCRINE BIOSCIENCES, INC.</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom"> <P STYLE="font-size:12pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman">Dated: February&nbsp;14, 2018</P></TD>
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<TD VALIGN="top">By:</TD>
<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1px solid #000000">&nbsp;</TD>
<TD VALIGN="top" STYLE="BORDER-BOTTOM:1px solid #000000">/s/ Darin M. Lippoldt</TD></TR>
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<TD VALIGN="bottom"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Darin M. Lippoldt</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman">Chief Legal Officer</P></TD></TR>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>d553580dex991.htm
<DESCRIPTION>EX-99.1
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right"><B>EXHIBIT 99.1 </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>FOR IMMEDIATE RELEASE </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Neurocrine
Biosciences Will File New Drug Application for Opicapone for </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Parkinson&#146;s Disease Based on Existing Pivotal Clinical Trial Data
</B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Neurocrine Plans to File the NDA During the First Half of 2019 </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">SAN DIEGO, Feb. 14, 2018&#151;Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused on neurological and endocrine related disorders,
today announced that the U.S. Food and Drug Administration (FDA) has provided guidance on the regulatory path forward to support the New Drug Application (NDA) for opicapone, an investigational drug for Parkinson&#146;s disease, after receiving
meeting minutes from the January 2018 meeting with the FDA. Most importantly, the Neurology Division of the FDA has not requested that Neurocrine conduct an additional Phase III study for opicapone prior to the NDA filing. As a result, Neurocrine
will proceed with plans to file the NDA for opicapone during the first half of 2019. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#147;We had a very productive meeting with the FDA and are pleased
that we can proceed with the NDA submission based on the robust clinical data that already exists for opicapone,&#148; said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine. &#147;We have a tremendous amount of work ahead of us as we
compile the <FONT STYLE="white-space:nowrap">FDA-required</FONT> datasets to prepare for the NDA filing, which we plan to have completed during the first half of 2019. As part of our commitment to helping patients with movement disorders, we are
eager to continue advancing this important medicine for the nearly one million patients suffering from Parkinson&#146;s disease in the United States.&#148; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Opicapone, an investigational drug in the U.S., is a once-daily, peripherally-acting, highly-selective <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">catechol-o-methyltransferase</FONT></FONT> (COMT) inhibitor being developed as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors for adult patients with Parkinson&#146;s disease and motor
fluctuations. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In February 2017, Neurocrine entered into an exclusive licensing agreement with BIAL for the development and commercialization of opicapone
in the United States and Canada. Under the terms of the agreement, Neurocrine is responsible for development and commercialization of opicapone in the United States and Canada. As a result of the FDA guidance for the NDA filing, Neurocrine will pay
a $10&nbsp;million milestone payment to BIAL. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Parkinson&#146;s Disease </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Parkinson&#146;s disease is a chronic and progressive movement disorder that affects approximately one million people in the United States. The disease is
characterized by a loss of neurons in the substantia nigra, the area of the brain where dopamine is produced. Dopamine production and synthesis is necessary for coordination and movement. As Parkinson&#146;s progresses, dopamine production steadily
decreases resulting in tremor, slowed movement (bradykinesia), impaired posture and balance, and speech and writing problems. There is no present cure for Parkinson&#146;s disease and management consists of controlling the motor symptoms primarily
through administration of levodopa therapies. While this improves the control of Parkinson&#146;s symptoms, the disease progresses and the beneficial effects of levodopa begin to wear off, symptoms worsen and patients experience <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">end-of-dose</FONT></FONT> motor fluctuations. These <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">end-of-dose</FONT></FONT> motor fluctuations are improved with the
addition of a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">catechol-o-methyltransferase</FONT></FONT> (COMT) inhibitor to levodopa. </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Opicapone </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Opicapone is a novel, once-daily, peripherally-acting, highly-selective
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">catechol-o-methyltransferase</FONT></FONT> (COMT) inhibitor proposed for use as adjunct therapy to levodopa/DOPA decarboxylase inhibitors in Parkinson&#146;s patients. Opicapone works
by prolonging the duration of effect of levodopa through decreasing its conversion rate into <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">3-O-methyldopa,</FONT></FONT> thereby reducing the
<FONT STYLE="white-space:nowrap">off-time</FONT> period of Parkinson&#146;s and extending the <FONT STYLE="white-space:nowrap">on-time</FONT> period.&nbsp;A novel compound discovered in the BIAL laboratories, it is designed to provide patients and
physicians with a once-daily treatment option without the deleterious side-effects and complicated dosing regimen of other COMT inhibitors. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In June 2016,
the European Commission authorized ONGENTYS<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP><SUP STYLE="font-size:85%; vertical-align:top"> </SUP>(opicapone) as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors
(DDCIs) in adult patients with Parkinson&#146;s disease and <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">end-of-dose</FONT></FONT> motor fluctuations who cannot be stabilized on those combinations. This European approval was
based on data from a clinical development program that included 28 clinical studies of more than 900 patients treated with opicapone in 30 countries worldwide. Opicapone is an investigational drug, not approved for use in the United States or
Canada. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The two pivotal Phase III studies utilized for European approval, <FONT STYLE="white-space:nowrap">BIPARK-I</FONT> and <FONT
STYLE="white-space:nowrap">BIPARK-II,</FONT> demonstrated that opicapone once-daily achieved a statistically significant decrease in <FONT STYLE="white-space:nowrap">off-time</FONT> periods for Parkinson&#146;s patients compared to placebo. The <FONT
STYLE="white-space:nowrap">BIPARK-I</FONT> study was a placebo-controlled study of approximately 600 patients that also included entacapone as an active comparator. The results of this study showed that once-daily opicapone was <FONT
STYLE="white-space:nowrap">non-inferior</FONT> to entacapone dosed multiple times per day. The <FONT STYLE="white-space:nowrap">BIPARK-II</FONT> study was a placebo-controlled study of approximately 400 patients that also showed a significant
decrease in <FONT STYLE="white-space:nowrap">off-time</FONT> periods for Parkinson&#146;s patients. In both studies, opicapone was associated with significant improvements in both patient and clinician global assessments of change. The data from
these two Phase III trials also demonstrated that opicapone improved motor fluctuations in levodopa-treated patients regardless of concomitant dopamine agonist or monoamine oxidase type B inhibitors used. Opicapone was generally well tolerated and
was not associated with relevant electrocardiographic or hepatic adverse events. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Both of the BIPARK Phase III trials included a <FONT
STYLE="white-space:nowrap">one-year</FONT> open-label extension where opicapone sustained the decrease in <FONT STYLE="white-space:nowrap">off-time</FONT> and increase in <FONT STYLE="white-space:nowrap">on-time&nbsp;periods</FONT> that was
demonstrated during the double-blind placebo-controlled portion of the studies. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Neurocrine Biosciences, Inc. </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Neurocrine Biosciences&nbsp;is a&nbsp;San Diego&nbsp;based biotechnology company focused on neurologic, psychiatric and endocrine related disorders. The
Company markets INGREZZA<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> (valbenazine) capsules in&nbsp;the United States&nbsp;for the treatment of adults with tardive dyskinesia.&nbsp;INGREZZA is a novel, selective vesicular monoamine
transporter 2 (VMAT2) inhibitor, and is the first FDA approved product indicated for the treatment of adults with tardive dyskinesia.&nbsp;The Company&#146;s three late-stage clinical programs are: elagolix, a gonadotropin-releasing hormone
antagonist for </P>

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women&#146;s health that is partnered with&nbsp;AbbVie Inc.; opicapone, a novel, once-daily, peripherally-acting, highly-selective
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">catechol-o-methyltransferase</FONT></FONT> inhibitor under investigation as adjunct therapy to levodopa in Parkinson&#146;s patients; and INGREZZA, a novel, once-daily, selective
VMAT2 inhibitor under investigation for the treatment of Tourette syndrome. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Neurocrine Biosciences, Inc. news releases are available through the
Company&#146;s website at http://www.neurocrine.com. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Forward-Looking Statements </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. Among the factors
that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine&#146;s business and finances in general, as well as risks and uncertainties associated
with opicapone development and commercialization. Specifically, the risks and uncertainties the Company faces include risks that opicapone may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; risks that
opicapone development activities may not be completed on time or at all; risks associated with the Company&#146;s dependence on BIAL for development and manufacturing activities related to opicapone; risks that ongoing or future opicapone clinical
trials may not be successful or replicate previous clinical trial results, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the FDA or regulatory authorities outside the U.S. may make adverse
decisions regarding opicapone; risks that opicapone may be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks and uncertainties relating to
competitive products and technological changes that may limit demand for opicapone; and other risks described in the Company&#146;s periodic reports filed with the Securities and Exchange Commission, including without limitation the Company&#146;s
annual report on Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the year ended December&nbsp;31, 2017. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof. </I></P>
<P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>### </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Contact: Neurocrine Biosciences,
Inc. </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Navjot Rai (Media&nbsp;&amp; Investors) </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">858-617-7623</FONT></FONT> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">IR@neurocrine.com </P>
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