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): November 23, 2009
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.) |
8001 Arista Place, Suite 200, Broomfield, CO 80021
(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)) |
| Item 8.01 | Other Events |
On November 23, 2009, ARCA biopharma, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has designated as a Fast Track development program the investigation of Gencaro, the Company’s investigational, pharmacologically unique beta-blocker and mild vasodilator, for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. The press release is attached as Exhibit 99.1 hereto, the contents of which are incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press Release titled “ARCA Receives FDA Fast Track Designation for Gencaro Development in Genotype-Defined Heart Failure Population”, dated November 23, 2009. |
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: November 23, 2009
| ARCA biopharma, Inc. (Registrant) | ||
| By: | /s/ KATHRYN E. FALBERG | |
| Name: | Kathryn E. Falberg | |
| Title: | Chief Financial Officer and Chief Operating Officer | |
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press Release titled “ARCA Receives FDA Fast Track Designation for Gencaro Development in Genotype-Defined Heart Failure Population”, dated November 23, 2009. |