<SEC-DOCUMENT>0001193125-18-312991.txt : 20181031
<SEC-HEADER>0001193125-18-312991.hdr.sgml : 20181031
<ACCEPTANCE-DATETIME>20181031080058
ACCESSION NUMBER:		0001193125-18-312991
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20181031
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20181031
DATE AS OF CHANGE:		20181031

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ACADIA PHARMACEUTICALS INC
		CENTRAL INDEX KEY:			0001070494
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				061376651
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-50768
		FILM NUMBER:		181148742

	BUSINESS ADDRESS:	
		STREET 1:		3611 VALLEY CENTRE DRIVE
		STREET 2:		SUITE 300
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92130
		BUSINESS PHONE:		858-558-2871

	MAIL ADDRESS:	
		STREET 1:		3611 VALLEY CENTRE DRIVE
		STREET 2:		SUITE 300
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92130
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
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<FILENAME>d646498d8k.htm
<DESCRIPTION>FORM 8-K
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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:18pt; 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:12pt; font-family:Times New Roman" ALIGN="center"><B>Date of Report (Date of earliest event reported): October&nbsp;31, 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>ACADIA Pharmaceuticals 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>
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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">000-50768</FONT></B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>061376651</B></TD></TR>
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<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 of</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>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" COLSPAN="3" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>3611 Valley Centre Drive, Suite 300</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>San Diego, California</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom" ALIGN="center"><B>92130</B></TD></TR>
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<TD VALIGN="top" COLSPAN="3" 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:10pt; font-family:Times New Roman" ALIGN="center"><B>Registrant&#146;s telephone number, including area code: (858)
<FONT STYLE="white-space:nowrap">558-2871</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 <FONT STYLE="white-space:nowrap">Form&nbsp;8-K&nbsp;is</FONT> intended to simultaneously satisfy the filing obligation
of the registrant under any of the following provisions (see General Instruction A.2. of <FONT STYLE="white-space:nowrap">Form&nbsp;8-K):</FONT> </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"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </P></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"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Soliciting material pursuant to <FONT STYLE="white-space:nowrap">Rule&nbsp;14a-12&nbsp;under</FONT> the
Exchange Act (17 <FONT STYLE="white-space:nowrap">CFR&nbsp;240.14a-12)</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement&nbsp;communications</FONT> pursuant to <FONT
STYLE="white-space:nowrap">Rule&nbsp;14d-2(b)&nbsp;under</FONT> the Exchange Act (17 <FONT STYLE="white-space:nowrap">CFR&nbsp;240.14d-2(b))</FONT> </P></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"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement&nbsp;communications</FONT> pursuant to <FONT
STYLE="white-space:nowrap">Rule&nbsp;13e-4(c)&nbsp;under</FONT> the Exchange Act (17 <FONT STYLE="white-space:nowrap">CFR&nbsp;240.13e-4(c))</FONT> </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; 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 (&#167; <FONT STYLE="white-space:nowrap">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; 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>
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<TD WIDTH="10%" VALIGN="top" ALIGN="left"><B>Item&nbsp;8.01</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Other Events. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On October&nbsp;31, 2018, ACADIA Pharmaceuticals Inc. announced positive <FONT STYLE="white-space:nowrap">top-line</FONT> results from CLARITY, a randomized,
double-blind, placebo-controlled multi-center, sequential parallel comparison design study in major depressive disorder (MDD). A copy of ACADIA&#146;s press release announcing the <FONT STYLE="white-space:nowrap">top-line</FONT> results is attached
as Exhibit 99.1. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Trial Design and <FONT STYLE="white-space:nowrap">Top-line</FONT> Results </U></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">CLARITY was a Phase 2, <FONT STYLE="white-space:nowrap">10-week,</FONT> randomized, double-blind, placebo-controlled, multi-center, <FONT
STYLE="white-space:nowrap">2-stage</FONT> sequential parallel comparison design (SPCD) study that evaluated the safety, tolerability and efficacy of pimavanserin (34 mg once daily) as an adjunctive treatment in patients with MDD who had inadequate
response to a stable dose of standard antidepressant therapy with either a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI). The study was conducted in collaboration with the MGH Clinical Trials
Network&nbsp;&amp; Institute and randomized 207 patients across 28 clinical research centers in the United States. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Consistent with the SPCD design,
CLARITY was conducted in two five-week sequential stages. Eligible subjects continued receiving their SSRI/SNRI antidepressant at a stable dose for the duration of the study. Patients were randomly assigned (1:3) to pimavanserin 34 mg/day or placebo
in Stage 1. Placebo <FONT STYLE="white-space:nowrap">non-responders</FONT> in Stage 1 (defined as <FONT STYLE="white-space:nowrap">HAMD-17</FONT> total score &gt;14 and a percent-reduction from baseline in
<FONT STYLE="white-space:nowrap">HAMD-17</FONT> total score of &lt;50% at week 5) were <FONT STYLE="white-space:nowrap">re-randomized</FONT> (1:1) to receive pimavanserin 34 mg/day or placebo. The primary endpoint of the study was the change in <FONT
STYLE="white-space:nowrap">HAMD-17</FONT> total score for Stage 1 and Stage 2. Treatment differences from Stage 1 and Stage 2 were combined as weighted averages. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In the trial, pimavanserin met the overall primary endpoint of the weighted average results of Stage 1 and Stage 2 by significantly reducing the <FONT
STYLE="white-space:nowrap">HAMD-17</FONT> total score compared to placebo (p=0.039). In addition, in Stage 1 (n=207) patients on pimavanserin demonstrated a highly significant improvement in <FONT STYLE="white-space:nowrap">HAMD-17</FONT>
(p=0.0003). Importantly, this group of patients saw a benefit over placebo in the first week of treatment (p=0.0365). Stage 2 (n=58) results did not demonstrate significant separation in this small set of placebo
<FONT STYLE="white-space:nowrap">non-responders.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On the key secondary endpoint, pimavanserin demonstrated statistically significant reductions
compared to placebo in the Sheehan Disability Scale (SDS) score (p=0.004). Positive results were also observed for seven other secondary endpoints listed below with nominal p values: Clinical Global Impression-Severity (p=0.0084), Clinical Global
Impression-Improvement (p=0.0289), Short <FONT STYLE="white-space:nowrap">Form-12</FONT> Mental Component Summary (p&lt;0.0001), Karolinska Sleepiness Scale (p=0.0205), Massachusetts General Hospital Sexual Functioning Index (p=0.0003), Barratt
Impulsiveness Scale (p=0.0075), as well as response rates (p=0.0065), defined as a 50% or greater reduction on the <FONT STYLE="white-space:nowrap">HAMD-17</FONT> total scale. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">A <FONT STYLE="white-space:nowrap">post-hoc</FONT> comparison between pimavanserin (n=51) and placebo (n=123) for patients consistently receiving either
placebo or pimavanserin for the entire <FONT STYLE="white-space:nowrap">10-week</FONT> period also yielded meaningful separation with positive <FONT STYLE="white-space:nowrap">p-values</FONT> at all weeks starting from week 2 to week 10 in favor of
pimavanserin for both the primary endpoint, <FONT STYLE="white-space:nowrap">HAMD-17</FONT> (week&nbsp;10, p=0.0076), and the key secondary endpoint, SDS (week 10, p=0.0094). </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Safety and Tolerability </U></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In CLARITY, pimavanserin was
generally well-tolerated. Discontinuations due to adverse events were 1.2% for pimavanserin and 3.2% for placebo. One subject in each of the pimavanserin and placebo groups reported serious adverse events (SAEs). These SAEs were deemed not to be
related to the study drug by the investigators and both subjects completed the study. No deaths were reported in the study. </P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="10%" VALIGN="top" ALIGN="left"><B>Item&nbsp;9.01</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Financial Statements and Exhibits. </B></P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">(d)</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">The following exhibit is furnished herewith: </P></TD></TR></TABLE>
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<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:1.00em; text-indent:-1.00em; font-size:10pt; font-family:Times New Roman"><A HREF="d646498dex991.htm">Press release dated October&nbsp;31, 2018 </A></P></TD></TR>
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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:12pt; 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">Date: October&nbsp;31, 2018</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" COLSPAN="3"><B>ACADIA Pharmaceuticals Inc.</B></TD></TR>
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<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">By:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Austin D. Kim</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">Name:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">Austin D. Kim</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Title:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">Executive Vice President, General Counsel&nbsp;&amp; Secretary</TD></TR>
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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="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>ACADIA Pharmaceuticals Announces Positive <FONT STYLE="white-space:nowrap">Top-line</FONT> Results from
Phase 2 CLARITY Trial of Pimavanserin for Adjunctive Treatment in Patients with Major Depressive Disorder (MDD) </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><I>- Pimavanserin met
primary endpoint with statistically significant overall improvement in <FONT STYLE="white-space:nowrap">HAMD-17</FONT> total score compared to placebo (p=0.039) </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><I>- Pimavanserin met key secondary endpoint with statistically significant overall improvement in Sheehan Disability Scale compared to placebo
(p=0.004) </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><I>- Positive results also observed on seven additional secondary endpoints including responder rate, improvement in sexual
function, and reduction in daytime sleepiness </I></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><I>- ACADIA to initiate Phase 3 program in adjunctive MDD in 1H 2019 </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><I>- Conference call and webcast to be held today at 8:30 a.m. Eastern Time </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>SAN DIEGO, CA, </B><B>October</B><B></B><B>&nbsp;31, 2018</B> &#150; ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced positive <FONT
STYLE="white-space:nowrap">top-line</FONT> results from CLARITY, a randomized, double-blind, placebo-controlled, multi-center, sequential parallel comparison design (SPCD) study in major depressive disorder (MDD). In the study, 207 adult patients
with a confirmed inadequate response to existing first-line SSRI or SNRI therapy for MDD received adjunctive treatment of either 34 mg pimavanserin or placebo in addition to <FONT STYLE="white-space:nowrap">pre-existing</FONT> first-line therapy for
five weeks (Stage 1). Those patients who did not show a response to placebo in Stage 1 were <FONT STYLE="white-space:nowrap">re-randomized</FONT> to receive either pimavanserin or placebo for a second five week treatment period (Stage 2). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In the trial, pimavanserin met the overall primary endpoint of the weighted average results of Stage 1 and Stage 2 by significantly reducing <FONT
STYLE="white-space:nowrap">17-item</FONT> Hamilton Depression Rating Scale <FONT STYLE="white-space:nowrap">(HAMD-17)</FONT> total score compared to placebo (p=0.039). In addition, in Stage&nbsp;1 (n=207) patients on pimavanserin demonstrated a
highly significant improvement in <FONT STYLE="white-space:nowrap">HAMD-17</FONT> (p=0.0003). Importantly, this group of patients saw a benefit over placebo in the first week of treatment (p=0.0365). Stage 2 (n=58) results did not demonstrate
significant separation in this small set of placebo <FONT STYLE="white-space:nowrap">non-responders.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On the key secondary endpoint, pimavanserin
demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale (SDS) score (p=0.004). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Positive results were also
observed for seven of the eleven other secondary endpoints listed below with nominal <FONT STYLE="white-space:nowrap">p-values:</FONT> Clinical Global Impression-Severity (p=0.0084), Clinical Global Impression-Improvement (p=0.0289), Short <FONT
STYLE="white-space:nowrap">Form-12</FONT> Mental Component Summary (p&lt;0.0001), Karolinska Sleepiness Scale (p=0.0205), Massachusetts General Hospital Sexual Functioning Index (p=0.0003), Barratt Impulsiveness Scale (p=0.0075), as well as response
rates (p=0.0065), defined as a 50% or greater reduction on the <FONT STYLE="white-space:nowrap">HAMD-17</FONT> total score. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In this Phase 2 study, pimavanserin was generally well-tolerated. Discontinuations due to adverse events
were 1.2% for pimavanserin and 3.2% for placebo. One subject in each of the pimavanserin and placebo groups reported serious adverse events (SAEs). These SAEs were deemed not to be related to the study drug by the investigators and both subjects
completed the study. No deaths were reported in the study. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#147;We are pleased with the robustness of the data from our Phase 2 CLARITY trial, which
shows significant promise for patients with MDD, including early and sustained antidepressant response over placebo, decreased daytime sleepiness, no meaningful weight gain, and improved sexual function. This is important because most people with
MDD do not respond to initial antidepressant therapies and experience significant unwanted side effects,&#148; said Serge Stankovic, M.D., M.S.P.H., ACADIA&#146;s Executive Vice President, Head of Research&nbsp;&amp; Development. &#147;Pimavanserin
is a selective serotonin inverse agonist, or SSIA, that shows great potential as an antidepressant. We look forward to engaging with the FDA and initiating a Phase 3 program in the first half of 2019.&#148; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#147;The results of this study suggest pimavanserin may represent a novel approach to adjunctive treatment for patients suffering from major depressive
disorder. The selective serotonergic mechanism of action may provide additional benefit for patients who do not adequately respond to SSRI or SNRI treatment,&#148; said Professor Maurizio Fava, M.D., Executive Vice Chair, Department of Psychiatry,
Massachusetts General Hospital (MGH) and Associate Dean for Clinical&nbsp;&amp; Translational Research, Harvard Medical School. &#147;The majority of patients with MDD do not respond adequately to initial antidepressant therapy and the treatment
effect seen in this study combined with a favorable tolerability profile provides evidence that adjunctive therapy with pimavanserin may benefit patients suffering from inadequate response in major depressive disorder.&#148; </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>About CLARITY </I></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">CLARITY was a Phase 2, 10 week,
randomized, double-blind, placebo-controlled, multi-center, <FONT STYLE="white-space:nowrap">2-stage</FONT> sequential parallel comparison design (SPCD) study that evaluated the safety, tolerability, and efficacy of pimavanserin (34 mg once daily)
as an adjunctive treatment in patients with MDD who had an inadequate response to a stable dose of standard antidepressant therapy with either a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI).
The study was conducted in collaboration with the MGH Clinical Trials Network&nbsp;&amp; Institute (CTNI) and randomized 207 patients across 28 clinical research centers in the United States. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Consistent with the SPCD design, the study was conducted in two, five week sequential stages. Eligible subjects continued receiving their SSRI or SNRI
antidepressant at a stable dose for the duration of the study. Patients were randomly assigned (1:3) to pimavanserin 34 mg/day or placebo in Stage 1. Placebo <FONT STYLE="white-space:nowrap">non-responders</FONT> in Stage 1 (defined as <FONT
STYLE="white-space:nowrap">HAMD-17</FONT> total score &gt;14 and a percent-reduction from baseline in <FONT STYLE="white-space:nowrap">HAMD-17</FONT> total score of &lt;50% at week 5) were <FONT STYLE="white-space:nowrap">re-randomized</FONT> (1:1)
to Stage 2 to receive pimavanserin 34 mg/day or placebo. The primary endpoint of the study was the change in <FONT STYLE="white-space:nowrap">HAMD-17</FONT> total score for Stage 1 and Stage 2. Treatment differences from Stage 1 and Stage 2 were
combined as weighted averages. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">A <FONT STYLE="white-space:nowrap">post-hoc</FONT> comparison between pimavanserin (n=51) and placebo
(n=123) for patients consistently receiving either placebo or pimavanserin for the entire 10 week period also yielded meaningful separation with positive <FONT STYLE="white-space:nowrap">p-values</FONT> at all weeks starting from week 2 to week 10
in favor of pimavanserin for both the primary endpoint, <FONT STYLE="white-space:nowrap">HAMD-17</FONT> (week 10, p=0.0076), and the key secondary endpoint, SDS (week 10, p=0.0094). </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>Conference Call and Webcast Information </I></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">ACADIA will
discuss <FONT STYLE="white-space:nowrap">top-line</FONT> results from its Phase 2 trial of pimavanserin for adjunctive treatment of patients with major depressive disorder via conference call and webcast today at 8:30 a.m. Eastern Time. The
conference call can be accessed by dialing <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">855-638-4820</FONT></FONT> for participants in the U.S. or Canada and
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">443-877-4067</FONT></FONT> for international callers (reference passcode 8786247). A telephone replay of the conference call may be accessed through November&nbsp;30, 2018 by dialing <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">855-859-2056</FONT></FONT> for callers in the U.S. or Canada and <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">404-537-3406</FONT></FONT> for international callers
(reference passcode 8786247). The conference call will also be webcast live on ACADIA&#146;s website, www.acadia-pharm.com, in the investors section and archived until November&nbsp;30, 2018. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>About Major Depressive Disorder (MDD) </I></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">According to the
National Institute of Mental Health, MDD affects approximately 16&nbsp;million adults in the United States<SUP STYLE="font-size:85%; vertical-align:top">1</SUP>, with approximately 2.5&nbsp;million adults treated with adjunctive therapy<SUP
STYLE="font-size:85%; vertical-align:top">2,3</SUP>. MDD is a condition characterized by depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities for more than two weeks, as well as impaired social,
occupational or other important functioning. The majority of people who suffer from MDD do not respond adequately to initial antidepressant therapy<SUP STYLE="font-size:85%; vertical-align:top">4</SUP>. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>About Pimavanserin </I></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Pimavanserin is a selective serotonin
inverse agonist (SSIA) preferentially targeting <FONT STYLE="white-space:nowrap">5-HT</FONT><SUB STYLE="font-size:85%; vertical-align:bottom">2A </SUB>receptors. These receptors are thought to play an important role in depression, psychosis, and
other neuropsychiatric disorders. ACADIA is evaluating pimavanserin in an extensive clinical development program across multiple indications with significant unmet need including dementia-related psychosis, schizophrenia inadequate response,
schizophrenia-negative symptoms, and major depressive disorder. Pimavanserin (34 mg) was approved for the treatment of hallucinations and delusions associated with Parkinson&#146;s disease psychosis by the U.S. Food and Drug Administration in April
2016 under the trade name NUPLAZID<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP>. NUPLAZID is not approved for the adjunctive treatment of patients with major depressive disorder. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>About ACADIA Pharmaceuticals </I></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">ACADIA is a
biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and is commercializing the first and only medicine approved
for the treatment of hallucinations and delusions associated with Parkinson&#146;s disease psychosis. In addition, ACADIA has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis,
schizophrenia inadequate response, schizophrenia-negative symptoms, major depressive disorder, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>Forward-Looking Statements </I></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to,
statements related to: the potential benefits of pimavanserin as adjunctive treatment for MDD or other central nervous system disorders as well as the potential results of clinical trials of pimavanserin in other indications. These statements are
only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks
and uncertainties inherent in drug discovery, development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to
ACADIA&#146;s annual report on Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the year ended December&nbsp;31, 2017 as well as ACADIA&#146;s subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in
their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>References </I></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><SUP STYLE="font-size:85%; vertical-align:top">1</SUP>National Institute of Mental Health. (2017). Major Depression. Retrieved from
<U>http://www.nimh.nih.gov/health/statistics/major-depression.shtml.</U> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><SUP STYLE="font-size:85%; vertical-align:top">2</SUP>IMS NSP, NPA, NDTI <FONT
STYLE="white-space:nowrap">MAT-24</FONT> month data through <FONT STYLE="white-space:nowrap">Aug-2017.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><SUP
STYLE="font-size:85%; vertical-align:top">3</SUP>PLOS One, Characterization of Treatment Resistant Depression Episodes in a Cohort of Patients from a US Commercial Claims Database, Oct 2013, Vol 8, Issue 10. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><SUP STYLE="font-size:85%; vertical-align:top">4</SUP>Rush AJ, et al. (2007)&nbsp;Am J. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study). </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>Investor Contact: </I></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">ACADIA Pharmaceuticals Inc. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Elena Ridloff, CFA </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">(858)
<FONT STYLE="white-space:nowrap">558-2871</FONT> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>ir@acadia-pharm.com </U></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>Media Contact: </I></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">ACADIA Pharmaceuticals Inc. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Maurissa Messier </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">(858)
<FONT STYLE="white-space:nowrap">768-6068</FONT> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>media@acadia-pharm.com </U></P>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
