Current Report Filing (8-k)
May 09 2017 - 7:39AM
Edgar (US Regulatory)
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 9, 2017
Protalix BioTherapeutics, Inc.
(Exact name of registrant as specified
in its charter)
Delaware
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001-33357
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65-0643773
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(State or other jurisdiction
of incorporation)
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(Commission File Number)
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(IRS Employer
Identification No.)
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2 Snunit Street
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20100
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Science Park, POB 455
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Carmiel, Israel
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(Address of principal executive offices)
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(Zip Code)
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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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¨
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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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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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 8.01. Other Events
On May 9, 2017, Protalix BioTherapeutics, Inc. (the “Company”)
issued a press release announcing that the U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug application
(IND) for a clinical trial evaluating the safety and efficacy of administering 2 mg/kg of pegunigalsidase alfa (PRX-102) once monthly
in Fabry patients. The current dosing regimen for approved enzyme replacement therapies for Fabry disease is once every two weeks.
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits
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99.1
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Press release dated May 9, 2017.
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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.
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PROTALIX BIOTHERAPEUTICS, INC.
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Date: May 9, 2017
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By:
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/s/ Moshe Manor
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Name:
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Moshe Manor
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Title:
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President and
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Chief Executive Officer
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