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): December 5, 2013 (December 4, 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 December 4, 2013, ARCA biopharma, Inc. (“ARCA”) announced that its Investigational New Drug application for GencaroTM, a pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation, has been accepted by the U.S. Food and Drug Administration and is now active. The press release is furnished as Exhibit 99.1 hereto, the contents of which are incorporated herein by reference.
Additionally, on December 5, 2013, ARCA announced that Laboratory Corporation of America (LabCorp®) has submitted an Investigational Device Exemption application to the U.S. Food and Drug Administration for the planned companion diagnostic test for Gencaro. The press release is furnished as Exhibit 99.2 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 U.S. FDA Acceptance of Gencaro IND Application for the Treatment of Atrial Fibrillation” dated December 4, 2013. | |
| 99.2 | Press Release titled “ARCA biopharma Announces IDE Submission to U.S. FDA for Gencaro Companion Diagnostic Test” dated December 5, 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: December 5, 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 U.S. FDA Acceptance of Gencaro IND Application for the Treatment of Atrial Fibrillation” dated December 4, 2013. | |
| 99.2 | Press Release titled “ARCA biopharma Announces IDE Submission to U.S. FDA for Gencaro Companion Diagnostic Test” dated December 5, 2013. | |