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 12, 2010 (July 12, 2010)
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
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| Florida
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001-33357
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65-0643773 |
| (State or other jurisdiction
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(Commission File Number)
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(IRS Employer |
| of incorporation)
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Identification No.) |
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| 2 Snunit Street
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| Science Park, POB 455 |
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| Carmiel, Israel |
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20100 |
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(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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b)) |
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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 12, 2010, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release announcing
that the Company’s New Drug Application (NDA) for taliglucerase alfa has been accepted for review
by the U.S. Food and Drug Administration (FDA). The FDA granted taliglucerase alfa a standard
review time of ten months, assigning a Prescription Drug User Fee Act (PDUFA) action date of
February 25, 2011. A copy of the press release is attached hereto as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
99.1 Press release dated July 12, 2010.
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