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EX-99.1 - EX-99.1 - ARCA biopharma, Inc.d619144dex991.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 29, 2013 (October 29, 2013)

 

 

ARCA biopharma, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware   000-22873   36-3855489

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

11080 CirclePoint Road, Suite 140, Westminster, CO 80020

(Address of Principal Executive Offices) (Zip Code)

(720) 940-2200

(Registrant’s telephone number, including area code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Section 8 — Other Events

Item 8.01. Other Events.

On October 29, 2013, ARCA biopharma, Inc. announced that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for the GENETIC-AF clinical trial of Gencaro (bucindolol hydrochloride), a pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation, and has established the Data Safety Monitoring Board for GENETIC-AF. The press release is furnished as Exhibit 99.1 hereto, the contents of which are incorporated herein by reference.

Section 9 — Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

Number

  

Description

99.1    Press Release titled “ARCA biopharma Announces IND Submission to U.S. FDA for Gencaro for the Treatment of Atrial Fibrillation” dated October 29, 2013.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: October 29, 2013

 

ARCA biopharma, Inc.

(Registrant)

By:  

/s/ Christopher D. Ozeroff

Name:   Christopher D. Ozeroff
Title:   SVP and General Counsel


INDEX TO EXHIBITS

 

Exhibit
Number

  

Description

99.1    Press Release titled “ARCA biopharma Announces IND Submission to U.S. FDA for Gencaro for the Treatment of Atrial Fibrillation” dated October 29, 2013.