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): February 2, 2010 (February 2, 2010)
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified in its charter)
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| Florida
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000-33357
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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 |
| (Address of principal executive offices)
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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 February 2, 2010, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release
announcing that, in connection with the New Drug Application (“NDA”) filed by the Company in
December 2009 for taliglucerase alfa for the treatment of Gaucher disease, the U.S. Food and Drug
Administration has requested additional data regarding the Chemistry, Manufacturing and Controls
(CMC) section of the NDA. No additional Clinical or Preclinical information was requested. 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 February 2, 2010.
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