-----BEGIN PRIVACY-ENHANCED MESSAGE-----
Proc-Type: 2001,MIC-CLEAR
Originator-Name: webmaster@www.sec.gov
Originator-Key-Asymmetric:
 MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen
 TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB
MIC-Info: RSA-MD5,RSA,
 TqQZbIe56pXu+7JVYZby7fZbGZdlDxSGkSRAya7FRoeMNh1iSkO9c1kF/KMmLj4O
 oWRYMl2kgxJYDziibZ1OBw==

<SEC-DOCUMENT>0001193125-09-122761.txt : 20090602
<SEC-HEADER>0001193125-09-122761.hdr.sgml : 20090602
<ACCEPTANCE-DATETIME>20090601203836
ACCESSION NUMBER:		0001193125-09-122761
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20090601
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20090602
DATE AS OF CHANGE:		20090601

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ARCA biopharma, Inc.
		CENTRAL INDEX KEY:			0000907654
		STANDARD INDUSTRIAL CLASSIFICATION:	IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835]
		IRS NUMBER:				363855489
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-22873
		FILM NUMBER:		09866515

	BUSINESS ADDRESS:	
		STREET 1:		8001 ARISTA PLACE
		STREET 2:		SUITE 200
		CITY:			BROOMFIELD
		STATE:			CO
		ZIP:			80021
		BUSINESS PHONE:		720-940-2200

	MAIL ADDRESS:	
		STREET 1:		8001 ARISTA PLACE
		STREET 2:		SUITE 200
		CITY:			BROOMFIELD
		STATE:			CO
		ZIP:			80021

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	NUVELO INC
		DATE OF NAME CHANGE:	20030203

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	HYSEQ INC
		DATE OF NAME CHANGE:	19970610
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>d8k.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<HTML><HEAD>
<TITLE>Form 8-K</TITLE>
</HEAD>
 <BODY BGCOLOR="WHITE">

 <P STYLE="line-height:0px;margin-top:0px;margin-bottom:0px;border-bottom:0.5pt solid #000000">&nbsp;</P> <P
STYLE="line-height:3px;margin-top:0px;margin-bottom:2px;border-bottom:0.5pt solid #000000">&nbsp;</P> <P STYLE="margin-top:24px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="4"><B>UNITED STATES </B></FONT></P> <P
STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="4"><B>SECURITIES AND EXCHANGE COMMISSION </B></FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman"
SIZE="3"><B>WASHINGTON, D.C. 20549 </B></FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="5"><B>FORM 8-K </B></FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px" ALIGN="center"><FONT
FACE="Times New Roman" SIZE="3"><B>CURRENT REPORT </B></FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="3"><B>Pursuant to Section&nbsp;13 or 15(d) of the </B></FONT></P> <P
STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="3"><B>Securities Exchange Act of 1934 </B></FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">Date
of earliest event reported: June&nbsp;1, 2009 </FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="6"><B>ARCA biopharma, Inc. </B></FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px"
ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>(Exact Name of Registrant as Specified in Charter) </B></FONT></P> <P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" ALIGN="center">

<TR>
<TD WIDTH="34%"></TD>
<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="32%"></TD>
<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="32%"></TD></TR>
<TR>
<TD VALIGN="top" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>Delaware</B></FONT></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="top" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>000-22873</B></FONT></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="top" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>36-3855489</B></FONT></TD></TR>
<TR>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>(State or Other Jurisdiction</B></FONT></P> <P STYLE="margin-top:0px;margin-bottom:1px" ALIGN="center"><FONT
FACE="Times New Roman" SIZE="1"><B>of Incorporation)</B></FONT></P></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="top" ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>(Commission File Number)</B></FONT></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>(I.R.S. Employer</B></FONT></P> <P STYLE="margin-top:0px;margin-bottom:1px" ALIGN="center"><FONT
FACE="Times New Roman" SIZE="1"><B>Identification No.)</B></FONT></P></TD></TR>
</TABLE> <P STYLE="margin-top:12px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>8001 Arista Place, Suite 200, Broomfield, CO 80021 </B></FONT></P> <P
STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>(Address of Principal Executive Offices) (Zip Code) </B></FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px" ALIGN="center"><FONT
FACE="Times New Roman" SIZE="2"><B>(720) 940-2200 </B></FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>(Registrant&#146;s telephone number, including area code) </B></FONT></P> <P
STYLE="margin-top:12px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</B></FONT></P> <P
STYLE="line-height:3px;margin-top:0px;margin-bottom:2px;border-bottom:0.5pt solid #000000">&nbsp;</P> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="1"><B>(Former Name or Former Address, if Changed
Since Last Report) </B></FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">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 (see General Instruction A.2. below): </FONT></P> <P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2"><FONT FACE="WINGDINGS">&#168;</FONT></FONT></TD>
<TD ALIGN="left" VALIGN="top"><FONT FACE="Times New Roman" SIZE="2">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </FONT></TD></TR></TABLE> <P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P>

<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2"><FONT FACE="WINGDINGS">&#168;</FONT></FONT></TD>
<TD ALIGN="left" VALIGN="top"><FONT FACE="Times New Roman" SIZE="2">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) </FONT></TD></TR></TABLE> <P
STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2"><FONT FACE="WINGDINGS">&#168;</FONT></FONT></TD>
<TD ALIGN="left" VALIGN="top"><FONT FACE="Times New Roman" SIZE="2">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) </FONT></TD></TR></TABLE> <P
STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2"><FONT FACE="WINGDINGS">&#168;</FONT></FONT></TD>
<TD ALIGN="left" VALIGN="top"><FONT FACE="Times New Roman" SIZE="2">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) </FONT></TD></TR></TABLE> <P
STYLE="font-size:24px;margin-top:0px;margin-bottom:0px">&nbsp;</P> <P STYLE="line-height:0px;margin-top:0px;margin-bottom:0px;border-bottom:0.5pt solid #000000">&nbsp;</P> <P
STYLE="line-height:3px;margin-top:0px;margin-bottom:2px;border-bottom:0.5pt solid #000000">&nbsp;</P>

<p Style='page-break-before:always'>
<HR  SIZE="3" COLOR="#999999" WIDTH="100%" ALIGN="CENTER">


<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="9%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2"><B>Item&nbsp;8.01</B></FONT></TD>
<TD ALIGN="left" VALIGN="top"><FONT FACE="Times New Roman" SIZE="2"><B>Other Events. </B></FONT></TD></TR></TABLE> <P STYLE="margin-top:6px;margin-bottom:0px; text-indent:4%"><FONT FACE="Times New Roman" SIZE="2">On June&nbsp;1, 2009, ARCA
biopharma, Inc. issued a press release entitled &#147;ARCA biopharma Receives Complete Response Letter From FDA on the Gencaro NDA.&#148; A copy of the press release is attached as Exhibit 99.1 to this report and is incorporated herein by reference.
</FONT></P> <P STYLE="font-size:18px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="9%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2"><B>Item&nbsp;9.01</B></FONT></TD>
<TD ALIGN="left" VALIGN="top"><FONT FACE="Times New Roman" SIZE="2"><B>Financial Statements and Exhibits. </B></FONT></TD></TR></TABLE> <P STYLE="font-size:6px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">(d)</FONT></TD>
<TD ALIGN="left" VALIGN="top"><FONT FACE="Times New Roman" SIZE="2">Exhibits. </FONT></TD></TR></TABLE> <P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" ALIGN="center">

<TR>
<TD></TD>
<TD VALIGN="bottom" WIDTH="3%"></TD>
<TD WIDTH="94%"></TD></TR>
<TR>
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR>
<TD VALIGN="top" NOWRAP ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">99.1</FONT></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;&nbsp;</FONT></TD>
<TD VALIGN="top"><FONT FACE="Times New Roman" SIZE="2">Press release, dated June&nbsp;1, 2009, entitled &#147;ARCA biopharma Receives Complete Response Letter From FDA on the Gencaro NDA.&#148;</FONT></TD></TR>
</TABLE>

<p Style='page-break-before:always'>
<HR  SIZE="3" COLOR="#999999" WIDTH="100%" ALIGN="CENTER">

 <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>SIGNATURES </B></FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px"><FONT FACE="Times New Roman"
SIZE="2">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. </FONT></P> <P
STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P><DIV ALIGN="right">
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="40%" BORDER="0">

<TR>
<TD WIDTH="6%"></TD>
<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="12%"></TD>
<TD VALIGN="bottom" WIDTH="1%"></TD>
<TD WIDTH="80%"></TD></TR>
<TR>
<TD VALIGN="top" COLSPAN="5"><FONT FACE="Times New Roman" SIZE="2"><B>ARCA biopharma, Inc.</B></FONT></TD></TR>
<TR>
<TD VALIGN="top" COLSPAN="5"><FONT FACE="Times New Roman" SIZE="2">(Registrant)</FONT></TD></TR>
<TR>
<TD HEIGHT="16"></TD>
<TD HEIGHT="16" COLSPAN="4"></TD></TR>
<TR>
<TD VALIGN="top"><FONT FACE="Times New Roman" SIZE="2">By:</FONT></TD>
<TD VALIGN="bottom" STYLE="BORDER-BOTTOM:1px solid #000000"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="top" COLSPAN="3" STYLE="BORDER-BOTTOM:1px solid #000000"><FONT FACE="Times New Roman" SIZE="2">/s/ Kathryn E. Falberg</FONT></TD></TR>
<TR>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="top"><FONT FACE="Times New Roman" SIZE="2">Name:</FONT></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="bottom"><FONT FACE="Times New Roman" SIZE="2">Kathryn E. Falberg</FONT></TD></TR>
<TR>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="top"><FONT FACE="Times New Roman" SIZE="2">Title:</FONT></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD VALIGN="bottom"><FONT FACE="Times New Roman" SIZE="2">Chief Financial Officer and Chief Operating Officer</FONT></TD></TR>
</TABLE></DIV> <P STYLE="margin-top:12px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">Dated: June&nbsp;1, 2009 </FONT></P>

<p Style='page-break-before:always'>
<HR  SIZE="3" COLOR="#999999" WIDTH="100%" ALIGN="CENTER">

 <P STYLE="margin-top:0px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2"><B>Exhibit Index </B></FONT></P> <P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE CELLSPACING="0" CELLPADDING="0" WIDTH="100%" BORDER="0" ALIGN="center">

<TR>
<TD></TD>
<TD VALIGN="bottom" WIDTH="3%"></TD>
<TD WIDTH="94%"></TD></TR>
<TR>
<TD HEIGHT="8"></TD>
<TD HEIGHT="8" COLSPAN="2"></TD></TR>
<TR>
<TD VALIGN="top" NOWRAP ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">99.1</FONT></TD>
<TD VALIGN="bottom"><FONT SIZE="1">&nbsp;&nbsp;</FONT></TD>
<TD VALIGN="top"><FONT FACE="Times New Roman" SIZE="2">Press release, dated June&nbsp;1, 2009, entitled &#147;ARCA biopharma Receives Complete Response Letter From FDA on the Gencaro NDA.&#148;</FONT></TD></TR>
</TABLE>
</BODY></HTML>
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>dex991.htm
<DESCRIPTION>PRESS RELEASE, DATED JUNE 1, 2009
<TEXT>
<HTML><HEAD>
<TITLE>Press release, dated June 1, 2009</TITLE>
</HEAD>
 <BODY BGCOLOR="WHITE">

 <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="right"><FONT FACE="Times New Roman" SIZE="2"><B>Exhibit 99.1 </B></FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px" ALIGN="right">

<IMG SRC="g33452g70x92.jpg" ALT="LOGO"> </P> <P STYLE="margin-top:12px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2"><B>Contact: </B></FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">Derek Cole
</FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">Vice President, Investor Relations&nbsp;&amp; Corporate Communications </FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px"><FONT FACE="Times New Roman"
SIZE="2">720.940.2163 </FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2"><U>derek.cole@arcabiopharma.com </U></FONT></P> <P
STYLE="margin-top:12px;margin-bottom:0px;padding-bottom:3px;line-height:95%; vertical-align:top" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2"><B>ARCA BIOPHARMA RECEIVES COMPLETE RESPONSE LETTER FROM FDA ON THE GENCARO<FONT
FACE="Times New Roman" SIZE="1"><SUP>TM</SUP></FONT><FONT FACE="Times New Roman" SIZE="2"> NDA </FONT></B></FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px;padding-bottom:3px;line-height:95%; vertical-align:top"><FONT FACE="Times New Roman"
SIZE="2"><I>Broomfield, CO, June&nbsp;1, 2009</I> &#150; ARCA biopharma, Inc. (Nasdaq: ABIO) announced today that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA, or the Agency) for its New Drug Application
(NDA) seeking approval for Gencaro</FONT><FONT FACE="Times New Roman" SIZE="1"><SUP>TM</SUP></FONT><FONT FACE="Times New Roman" SIZE="2"> (bucindolol hydrochloride) for the treatment of patients with chronic heart failure. </FONT></P> <P
STYLE="margin-top:12px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">In its Complete Response letter, the FDA states that it cannot approve the NDA in its current form and specifies additional actions and information required by the
Agency for approval of the Gencaro NDA. The Agency acknowledges that several substantial amendments to the NDA submitted by the Company in May 2009 were not reviewed or considered by the FDA in issuing the Complete Response letter, and that these
amendments may be referenced in the Company&#146;s response to the Complete Response letter. These unreviewed submissions deal with comparative effectiveness, clinical pharmacology, some aspects of pharmacogenetic data, and toxicology/metabolism.
</FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">Among other things, the Complete Response letter states that the Company must undertake the following actions to obtain approval: </FONT></P> <P
STYLE="font-size:6px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="4%"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">&#149;</FONT></TD>
<TD WIDTH="1%" VALIGN="top"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">Conduct an additional clinical efficacy trial of Gencaro in patients with heart failure; </FONT></P></TD></TR></TABLE> <P
STYLE="font-size:6px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="4%"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">&#149;</FONT></TD>
<TD WIDTH="1%" VALIGN="top"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">Conduct additional clinical pharmacology studies to address drug-drug interaction and pharmacokinetic issues; and, </FONT></P></TD></TR></TABLE> <P
STYLE="font-size:6px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="4%"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">&#149;</FONT></TD>
<TD WIDTH="1%" VALIGN="top"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">Conduct additional non-clinical studies to further characterize Gencaro metabolites. </FONT></P></TD></TR></TABLE> <P
STYLE="margin-top:12px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">In its Complete Response letter, FDA asserts that the BEST clinical study, which serves as the pivotal Phase III trial for the application, does not adequately
demonstrate efficacy of Gencaro in reducing all-cause mortality in patients with heart failure. The letter raises concerns regarding the integrity of the BEST data based on its audit of certain clinical sites involved in the BEST trial, which may
require an independent audit of additional clinical sites and other actions to verify the integrity of the data. In addition, the Complete Response letter raises concerns as to the statistical significance of some of the pharmacogenetic data relied
upon by the Company to assert that individual patient response to Gencaro may be predicted by genotype. </FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">The Company believes that data and information
submitted to FDA in May 2009, which the Agency acknowledges were not reviewed before sending the Complete Response letter, may address several of the deficiencies raised by FDA and may limit the need for some of the actions specified in the letter.
In particular, ARCA believes a submitted comparative effectiveness analysis demonstrates that Gencaro is as effective in reducing all-cause mortality as other &szlig;-blocker therapies, when comparable patient populations are analyzed. In addition,
the May 2009 submissions to FDA included two of the requested clinical pharmacology studies, plus non-clinical data and designs of ongoing preclinical studies that were specified by FDA in the Complete Response letter. ARCA also submitted a response
to some of the pharmacogenetic issues in the May amendments and plans to conduct additional analyses in response to the Agency&#146;s letter. </FONT></P>

<p Style='page-break-before:always'>
<HR  SIZE="3" COLOR="#999999" WIDTH="100%" ALIGN="CENTER">

 <P STYLE="margin-top:0px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">&#147;The Company is reviewing the Complete Response letter and plans to discuss it with FDA as soon as possible,&#148;
said Michael R. Bristow, Founder and Chief Science and Medical Officer ARCA. &#147;We appreciate FDA&#146;s review of the NDA and will continue to work with FDA to resolve the issues raised in the Complete Response letter.&#148; </FONT></P> <P
STYLE="margin-top:18px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2"><B>About ARCA biopharma </B></FONT></P> <P STYLE="margin-top:6px;margin-bottom:0px;padding-bottom:3px;line-height:95%; vertical-align:top"><FONT FACE="Times New Roman"
SIZE="2">ARCA biopharma, Inc. is dedicated to developing and commercializing genetically targeted therapies for heart failure and other cardiovascular disease. The Company&#146;s lead product candidate, Gencaro</FONT><FONT FACE="Times New Roman"
SIZE="1"><SUP>TM</SUP></FONT><FONT FACE="Times New Roman" SIZE="2"> (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for heart failure and other indications. ARCA has
identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted heart failure treatment. The New Drug Application for approval of Gencaro for the
indication of chronic heart failure, including the proposed brand name, was filed in September 2008. On May&nbsp;29, 2009, ARCA received a Complete Response letter from the FDA. ARCA is collaborating with Laboratory Corporation of America to develop
the companion genetic test for Gencaro. For more information please visit <U>www.arcabiopharma.com</U>. </FONT></P> <P STYLE="margin-top:18px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2"><B>Safe Harbor Statement </B></FONT></P> <P
STYLE="margin-top:6px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">This press release contains &#147;forward-looking statements&#148; for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These
statements include, but are not limited to, statements regarding the timing and outcome of regulatory review and approval of the Company&#146;s New Drug Application for Gencaro; the prospects for ARCA&#146;s providing sufficient information in a
timely manner as requested in the FDA&#146;s Complete Response letter; and, the company&#146;s ability to fund future operations. Such statements are based on management&#146;s current expectations and involve risks and uncertainties. Actual results
and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the company&#146;s financial resources and
whether they will be sufficient to meet the company&#146;s business objectives and operational requirements; the company&#146;s ability to complete a strategic transaction to support the potential commercialization of Gencaro, if approved and/or
obtain additional financing; the timing and outcome of the FDA&#146;s review of the company&#146;s New Drug Application for Gencaro, the company&#146;s ability to further identify, develop and achieve commercial success for products and
technologies; drug discovery and the regulatory approval process; clinical development processes; relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements;
and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA&#146;s filings with the SEC, including without limitation the company&#146;s annual report on Form
<BR>10-K for the year ended December&nbsp;31, 2008, the company&#146;s quarterly report on Form 10-Q for the quarter ended March&nbsp;31, 2009 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.
</FONT></P> <P STYLE="margin-top:6px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">### </FONT></P>
</BODY></HTML>
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>GRAPHIC
<SEQUENCE>3
<FILENAME>g33452g70x92.jpg
<DESCRIPTION>GRAPHIC
<TEXT>
begin 644 g33452g70x92.jpg
M_]C_X``02D9)1@`!`0$`8`!@``#_VP!#``H'!P@'!@H("`@+"@H+#A@0#@T-
M#AT5%A$8(Q\E)"(?(B$F*S<O)BDT*2$B,$$Q-#D[/CX^)2Y$24,\2#<]/CO_
MVP!#`0H+"PX-#AP0$!P[*"(H.SL[.SL[.SL[.SL[.SL[.SL[.SL[.SL[.SL[
M.SL[.SL[.SL[.SL[.SL[.SL[.SL[.SO_P``1"`!%`,H#`2(``A$!`Q$!_\0`
M'P```04!`0$!`0$```````````$"`P0%!@<("0H+_\0`M1```@$#`P($`P4%
M!`0```%]`0(#``01!1(A,4$&$U%A!R)Q%#*!D:$((T*QP152T?`D,V)R@@D*
M%A<8&1HE)B<H*2HT-38W.#DZ0T1%1D=(24I35%565UA96F-D969G:&EJ<W1U
M=G=X>7J#A(6&AXB)BI*3E)66EYB9FJ*CI*6FIZBIJK*SM+6VM[BYNL+#Q,7&
MQ\C)RM+3U-76U]C9VN'BX^3EYN?HZ>KQ\O/T]?;W^/GZ_\0`'P$``P$!`0$!
M`0$!`0````````$"`P0%!@<("0H+_\0`M1$``@$"!`0#!`<%!`0``0)W``$"
M`Q$$!2$Q!A)!40=A<1,B,H$(%$*1H;'!"2,S4O`58G+1"A8D-.$E\1<8&1HF
M)R@I*C4V-S@Y.D-$149'2$E*4U155E=865IC9&5F9VAI:G-T=79W>'EZ@H.$
MA8:'B(F*DI.4E9:7F)F:HJ.DI::GJ*FJLK.TM;:WN+FZPL/$Q<;'R,G*TM/4
MU=;7V-G:XN/DY>;GZ.GJ\O/T]?;W^/GZ_]H`#`,!``(1`Q$`/P#OM6UJ:69[
M>V8QQH2I93RW_P!:LV.%I&^8GGJ3201&1_4GUK9M;4-B.0;&_A)'Z&OC$JN,
MJ.4W_78]%\M-61GI8,7*D<@&F-9G:6QP*Z)4A21=[#S`I5@!GVILEHC0J`P"
M+R[>_P!*[7EL>70R]L[G,H\]J^^*1T([J<5U&C:D=0MV$F!-'PV.X]:Q[NW+
M`E4*H.F:E\-C;?3#_IG_`%K/`RJ8?$JG?W655M.#?4Z2BBBOJCA*>KZC'I&E
M7-_+@K"A8#^\>P_$U6\-:T-?T.&_*JDC965%Z*PZUD>*XG\0:I;^&X9"JB-K
MFY8=L#"#\ZP/AGJ+V>JW>C7'RF3+JI[.O##\OY4`>EU7OY+R*U9[&WCN)P1B
M.238"._.#5BB@#A]2^(5YHUT;74?#[0S`;@!<@@CU!QTK3M-=\27]JEU;^&X
MUBD4,GFW@4D>N,5R?Q4_Y#=G_P!>W_LQKT;2O^019?\`7O'_`.@B@#GX_'D%
MMJ/]GZWIT^ES<?,S!TY[Y';WKJE8,H92"",@CH:\]^*\<>S39<#S"77/<KQ7
M2^"'FD\(6!GSN"$*3U*@G'Z4`;KNL:,[L%51DLQP`*Y:;QQ'=7QL-`T^75)Q
MU=3LC7W+'M7/?$/7Y[S45\/V3'8I43!3_K'/1?H./QKMO#NA6_A_28[2)09"
M`TTF.7?O^'I0!5#^,73?Y.CQG_GF6D8_F*Q=3\;:]H$JIJ^@Q!6^[)#,=C?0
MX/Y5W-4]6TR#6-,GL;A04E4@$C[I[$?0T`68)1/;QS+TD0,/Q&:?572[::RT
MJUM9W5Y88EC9EZ$@8S5J@#.\0:NFAZ+<7[`,T:XC4_Q,>`*70=576M%MM04!
M3*GSJ.BL."/SKG/%=M+XFU9M$MW(2QMVN)2.\I&$7_/K6=\+M4*F[TB4X(_?
M1@_DP_E0!Z)1110!QMFJ$C+8_"MV!_+M9/+F+E4)"E>G%<[;2!&&1FMVSNCM
M!9@D8_A4?>]J^4RZ<5IL=U9,CT^9-H).<]:T1.KSJ%[CGC-43IL3R!X)C#Y@
M+>7C(`J>)8;5`WF,QD'^L_NGZ5Z-#VL%RRM9=?ZU,96>J*U_L<DF<L?=>E1^
M'P!J$V#G]WZ>XIE]<DDB4*Q_O#J?QI?#AW:A,1_SS_J*XXSC+&PMW-+-4V='
M3)IH[>"2>5@L<:EF)[`<FGURWCJ\D:RMM$M3_I.J2B/CLF?F/\OUKZ8XS.\*
M^(=($NH:OJ.I6\-W?3<1N_*1KPHKF->O[/3_`!NNKZ3=13Q%UG/E-D`]&4_7
MG\Z]7MM-L[2UBMX[>+;$@090=ABN8^(NBQW'A[[9!"JR6;[SM4#*'@_T/X4`
M==!-'<V\<\3;HY5#J?4$9I]<E\.-5^W^'?LCMF6R;9_P`\K_`%'X5UM`'EWQ
M4_Y#=G_U[?\`LQK>D\7WNB:):RW7AVX$(B15E$RE#P,9QTS6#\5/^0W9_P#7
MM_[,:]!M;2"^\.6]I<H'AFM45U/<;10!QVF6(^(5Y_:VIW*+;VS;%L8<Y7O\
MQ/K[5W\<:0QI%&@1$`5548``[5Y%!+>?#_Q<T;[GMR<,/^>L1Z'ZC^8KUNWN
M(KNWCN('$D4JAD8="#0!Y!IQ^T?$F,S\DZ@Q.?4,<?R%>QUY)XPLI_#OC)=2
MB3]W+*+F(]MP.67\_P"=>IV%]!J5C#>VSAHIE#*?Z?6@"Q111G`R>!0`5!>W
M<5A937<YQ'"A=OH*KZ1J\.LP37%NC"&.9HD<GB3;_$/:L'QM.]]-I_ANW8B2
M_E#38_AB!Y_S[4`5/".O:/;6=S?ZAJEM'?:A.TTJL_*#.%7\!_.N5N=0M-%\
M>_VCIUS'/:&829C.1M;[R_J:];CL;2*-8TMH@J`*!L'05QGQ+T:.32(=1@B5
M6MGVR;5QE6_P./SH`[E65U#J0589!'<4M<UX"U7^T_#,*.V9K0^2^>N!]T_E
MC\JZ6@#CM3L);"Z;*GRF8E&[8]*CAN2"`QXKLW1)$*.H93U!&150Z-IQ.?LJ
M?@2*^>JY1-5'*C*R[,ZXXA6M)&)'J&92Y/8CZ#%1O?9C*9]Q6_\`V-IW_/LO
MYFD_L73O^?5?S-4\!C&K<R_'_(7M:?8Y26=G&,\5T'AZPDMXGN)5*M*`%!ZX
MJ_#IEC`X>.V0,.A(SC\ZM5K@LL=&I[6I*[6PJE92CRQ15U"XN[:WWV5B;R4G
M'EB4)@>N37%'2_&$GBF+7[C3;>4Q`JEN+A0%7!&`?7G.:[^JZ7T,EXUJFXR*
M,M\N`M>T<P64UQ<6JR75H;24DYB+A\?B.*S?$$NK2VT]C8:.MTD\)4S/.J*,
M@@\'DXK:J*.ZAEGD@1\R1??&.E`'F^@>&?&'AR^^UVMI!(&7;)$TXPX_Q]Z[
MI+_53IK3OHK+=!MHMA<H=P]=W3%:=%`'FWB3PYXK\3:@MW+IUO;JB;$C%PIP
M,YY/KS74Z#<>(8(K:QU/1T5(U$9N8KA2``."5Z_E7044`<YXS\-?\)#I?[A5
M^VV_S0D\;O52??\`G6/X9L_&7AZV^ROIL%U:YRL9N55D]<'T]J[.&^AN+F2W
MCW%HQER5P![58H`S+W3(/$.D"WU6S,1<9*;P6B;U##O7,6&A^)_"$SKI9BU7
M3W;<8&;8X]QGH?I7=44`8"^)KO9^\\,ZLLG]T(I'YYK*UEO&/B"V:TL]-33+
M:08=I9QYC#TXZ"NTHH`Y_3+/4/#GAFSLK73UOKE`?,"S!%!))SD]16!:Z9XO
MA\4MK]UIMO<.RE/)6X4;%[!3[?XUW]%`$-I+--:I)<6YMI6'S1%PQ7\1P:Q/
M$W]L7UE=:98Z.L\<\>W[1)<*JC/^SUXKH:*`/-_#GA_QAX9O&F@LH)HI`!+"
M;A1N`[@]C77C5M:QSX:F!_Z^X_\`&MFB@`HHHH`****`"BBB@!KNL:,['"J,
MDUA6M^\,4^H?9VE\Z3YFS@*O0`>M:&LB5M.9(E9M[`-M&2%[TBV_VI88A$T5
MI#@A6&#(1TX["@"Y+,(HMY!.>@'4U!IUS]L@-QY`B+,1QSN`[YJ/6&F^R"&!
M'8S,$8H,E5[U8AB:.S$2J(R%PH!Z>E`$$FI9,Y@B\R.W'[QRV!GT'J:M1SI)
M;K.N2K+N''-9$4$YTI-.CC999"?.=A@*,\\]ZO7T@T_2F$?55$<?U/`H`HIJ
M=RIN;_RR]JKA`I;!4>H%;'FIY/G9^3;NS[8S62MJT^G0:=$CJO!G=EQCN1[G
M-7-324V'V>W0DR$1\?PCN?RH`SK*]DAM+B^6`RF1R[L6P%'8>YK;AE$T"2@8
M#J&P>U9[1">W.FPPR11HP5W9<`J.3CU)J353)'9)%!&[*S*CB,9(3O0`7>IB
M"`S10F5<[5;.`Q]O6K3RM%`'="7P,JOK67(MS<:I"IMF6&%=T:$?*#V)/MZ5
M>U0S&Q>.!&:23"#';/4T`5K?5IKJ%9(+%G^?#X;A1_6K=]>"R@:387(&<9P/
MSI]I;):6R0)T0<GU/<U4U""2^NH;38PMQ\\K=CZ"@"-M:*);2-;$).0,[N?P
M'>K%M?O<7LMLUN8_+4-G=GKV/H:K"&1[N:^D@;;;*4MXL=<=\5-H\4J6[23(
M5>4[W+?>)/MZ4`7)ITA`W9+,<*J\EC5>VO9+B]E@\@(L(&YMV>3VJHTUV+J]
ME6VD:1!MB8CY0H]/4FI]&ADBL\R(59SN8O\`>9CUH`T****`"BBB@`HHHH`*
M***`"BBB@`HHHH`*Y_5=0)U*&%HP8X)`Q&?O&BB@#H`<@&BBB@`HHHH`****
3`"BBB@`HHHH`****`"BBB@#_V3\_
`
end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
-----END PRIVACY-ENHANCED MESSAGE-----
