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 21, 2013
Keryx Biopharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
| | | | |
| Delaware | | 000-30929 | | 13-4087132 |
(State or Other Jurisdiction of Incorporation) | | (Commission
File Number) | | (IRS Employer
Identification No.) |
750 Lexington Avenue
New York, New York 10022
(Address of Principal Executive Offices)
(212) 531-5965
(Registrant’s telephone number, including area code)
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:
| | ¨ | Written communications pursuant to Rule 425 under the Securities Act. |
| | ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act. |
| | ¨ | Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act. |
| | ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. |
Item 8.01 Other Events.
On October 21, 2013, Keryx Biopharmaceuticals, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014, for the Company’s New Drug Application (NDA) for ZerenexTM (ferric citrate coordination complex), the Company’s drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis. A copy of the press release is being filed as Exhibit 99.1 to this report.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
The following exhibits are filed as part of this report:
| | |
Exhibit Number | | Description |
| |
| 99.1 | | Press Release dated October 21, 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.
| | | | | | |
| | | | Keryx Biopharmaceuticals, Inc. |
| | | | (Registrant) |
| | | |
| Date: October 21, 2013 | | | | | | |
| | | |
| | | | By: | | /s/ James F. Oliviero |
| | | | | | James F. Oliviero |
| | | | | | Chief Financial Officer |
INDEX TO EXHIBITS
| | |
Exhibit
Number | | Description |
| |
| 99.1 | | Press Release dated October 21, 2013. |
