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): August 13, 2012

 

 

 

Protalix BioTherapeutics, Inc.

(Exact name of registrant as specified in its charter)

  

 

         
Florida   001-33357   65-0643773

(State or other jurisdiction

of incorporation)

   (Commission File Number)  

(IRS Employer

Identification No.)

 

     
2 Snunit Street  
Science Park, POB 455    
Carmiel, Israel    20100
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code +972-4-988-9488

(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 August 13, 2012, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release announcing that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration to initiate clinical trials of PRX-102. The Company plans to commence enrollment of Fabry disease patients for a phase I/II trial in the fourth quarter of 2012.

 

A copy of the press release is filed as Exhibit 99.1.

 

Item 9.01.  Financial Statements and Exhibits

 

(d)           Exhibits

 

99.1           Press release dated August 13, 2012

 

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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.

 

 

 

  PROTALIX BIOTHERAPEUTICS, INC.
   
Date: August 13, 2012 By:         /s/ David Aviezer, Ph.D.  
 

Name:    David Aviezer, Ph.D.

Title:      President and Chief Executive Officer

   

 

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