Unassociated Document
 


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 30, 2010
 

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 November 30, 2010, Keryx Biopharmaceuticals, Inc. (the “Company”) announced positive top-line results from the Phase 3 short-term efficacy study component of its Phase 3 registration program of ZerenexTM (ferric citrate), the Company's ferric iron-based phosphate binder for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis..  A copy of such press release is being furnished as Exhibit 99.1 to this report.
 
Cautionary Statement
 
Some of the statements included in this report, particularly those anticipating future clinical trials and business prospects for ZerenexTM may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for Zerenex; top-line results are based on a preliminary analysis of then available data (both safety and efficacy) and there is the risk that that such findings and conclusions could change following a more comprehensive review of the data; the risk that the data (both safety and efficacy) from the long-term Phase 3 trial will not coincide with the data analyses from the short-term Phase 3 and Phase 2 clinical trials previously reported by the Company; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission.  Any forward-looking statements set forth in this report speak only as of the date of this report.  We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
 

 
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:  November 30, 2010      
 
By:
/s/ James F. Oliviero  
   
James F. Oliviero
 
   
Chief Financial Officer
 
       
 

 
INDEX TO EXHIBITS


Exhibit
Number
Description

99.1 
Press Release dated November 30, 2010.