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): July 2, 2014
REGADO BIOSCIENCES, INC.
(Exact Name of Registrant as Specified in its Charter)
| | | | |
Delaware | | 001-35953 | | 03-0422069 |
(State or Other Jurisdiction of Incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
| | |
120 Mountain View Boulevard, Basking Ridge, New Jersey | | 07920 |
| (Address of Principal Executive Offices) | | (Zip Code) |
Registrant’s telephone number, including area code(908) 580-2100
(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 July 2, 2014, Regado Biosciences, Inc., or the Company, issued a press release announcing, among other things, that the Data Safety Monitoring Board, or DSMB, has initiated an unplanned review of data from the Company’s Phase 3 trial of Revolixys™ Kit (previously known as REG1), entitled REGULATE-PCI, and that patient enrollment has been paused in the REGULATE-PCI trial until the DSMB has completed its analysis and communicated its recommendations. The foregoing summary of the press release does not purport to be complete and is qualified in its entirety by reference to the complete press release, a copy of which is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
At 8:30 a.m. Eastern Daylight Time on July 3, 2014, the Company will hold a conference call to discuss the REGULATE-PCI trial.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. | | Description |
| |
| 99.1 | | Press Release issued by Regado Biosciences, Inc., dated July 2, 2014. |
SIGNATURE
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.
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| REGADO BIOSCIENCES, INC. |
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| By: | | /s/ R. Don Elsey |
Name: Title: | | R. Don Elsey Senior Vice President, Finance and Chief Financial Officer |
Date: July 2, 2014
INDEX OF EXHIBITS
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Exhibit No. | | Description |
| |
| 99.1 | | Press Release issued by Regado Biosciences, Inc., dated July 2, 2014. |
