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): May 1, 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 | 20100 | |
| Science Park, POB 455 | ||
| Carmiel, Israel | ||
| (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 May 1, 2012, Protalix BioTherapeutics, Inc. (the "Company") issued a press release announcing that the United States Food and Drug Administration ("FDA") approved ELELYSO™ (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease. Also on May 1, 2012, the Company issued a second press release announcing that the Company has scheduled a conference call and webcast for Wednesday, May 2 at 8:00 AM EDT to review the FDA's approval of ELELYSO™ and that a second conference call, in Hebrew, is scheduled also on Wednesday at 9:45 AM EDT (4:45 PM IDT). Copies of the press releases are attached hereto as Exhibits 99.1 and 99.2.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
99.1 Press release dated May 1, 2012.
99.2 Press release dated May 1, 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: May 2, 2012 | By: | /s/ David Aviezer |
| Name: | David Aviezer, Ph.D. | |
| Title: | President and Chief Executive Officer | |
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