<SEC-DOCUMENT>0001144204-18-004740.txt : 20180131
<SEC-HEADER>0001144204-18-004740.hdr.sgml : 20180131
<ACCEPTANCE-DATETIME>20180131074328
ACCESSION NUMBER:		0001144204-18-004740
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20180131
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20180131
DATE AS OF CHANGE:		20180131

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Protalix BioTherapeutics, Inc.
		CENTRAL INDEX KEY:			0001006281
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				650643773
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33357
		FILM NUMBER:		18561022

	BUSINESS ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			20100
		BUSINESS PHONE:		972-4-988-9488

	MAIL ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			20100

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ORTHODONTIX INC
		DATE OF NAME CHANGE:	19980422

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	EMBASSY ACQUISITION CORP
		DATE OF NAME CHANGE:	19960124
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>tv484489_8k.htm
<DESCRIPTION>8-K
<TEXT>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Washington, D.C. 20549</B></P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>FORM 8-K</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>CURRENT REPORT </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Pursuant to Section 13 or 15(d) of </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>the Securities Exchange Act of 1934 </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Date of Report (Date of Earliest Event
Reported): January 31, 2018</B></P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Protalix BioTherapeutics, Inc.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Exact name of registrant as specified
in its charter) </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>



<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
<TR>
    <TD STYLE="width: 33%">&nbsp;</TD>
    <TD STYLE="width: 34%">&nbsp;</TD>
    <TD STYLE="width: 33%">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>Delaware</B></FONT></TD>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>001-33357</B></FONT></TD>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>65-0643773</B></FONT></TD></TR>
<TR>
    <TD STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(State or other jurisdiction</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>of incorporation)</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P></TD>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>(Commission File Number)</B></FONT></TD>
    <TD STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(IRS Employer</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Identification No.)</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
<TR>
    <TD STYLE="vertical-align: top; text-align: center; width: 55%"><FONT STYLE="font-size: 10pt"><B>2 Snunit Street</B></FONT></TD>
    <TD STYLE="vertical-align: top; text-align: center; width: 45%"><FONT STYLE="font-size: 10pt"><B>20100</B></FONT></TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>Science Park, POB 455</B></FONT></TD>
    <TD STYLE="vertical-align: top; text-align: center">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>Carmiel, Israel</B></FONT></TD>
    <TD STYLE="vertical-align: top; text-align: center">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>(Address of principal executive offices)</B></FONT></TD>
    <TD STYLE="vertical-align: top; text-align: center"><FONT STYLE="font-size: 10pt"><B>(Zip Code)</B></FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Registrant&rsquo;s telephone number,
including area code +972-4-988-9488</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Former name or former address, if changed
since last report.) </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>





<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 13.7pt 0pt 0">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 (<I>see</I>
General Instruction A.2. below):</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 13.7pt 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 28.6pt"></TD><TD STYLE="width: 21.6pt"><FONT STYLE="font-family: Wingdings"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></TD><TD>Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Times New Roman, Times, Serif">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 28.6pt"></TD><TD STYLE="width: 21.6pt"><FONT STYLE="font-family: Wingdings"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></TD><TD>Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Times New Roman, Times, Serif">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 28.6pt"></TD><TD STYLE="width: 21.6pt"><FONT STYLE="font-family: Wingdings"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></TD><TD>Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Times New Roman, Times, Serif">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 28.6pt"></TD><TD STYLE="width: 21.6pt"><FONT STYLE="font-family: Wingdings"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></TD><TD>Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Times New Roman, Times, Serif">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 21.85pt 0pt 0">Indicate by check mark whether the registrant is
an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR &sect;230.405) or Rule 12b-2 of the Securities
Exchange Act of 1934 (17 CFR &sect;240.12b-2).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 21.85pt 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 4in; text-align: right; text-indent: 0.5in">Emerging growth
company <FONT STYLE="font-family: Times New Roman, Times, Serif"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 4in; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. <FONT STYLE="font-family: Times New Roman, Times, Serif"><FONT STYLE="font-family: Wingdings">&#168;</FONT></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 11%; padding: 0; text-indent: 0"><FONT STYLE="font-size: 10pt"><B>Item 8.01.</B></FONT></TD>
    <TD STYLE="width: 89%; padding: 0; text-indent: 0"><FONT STYLE="font-size: 10pt"><B>Other Events</B></FONT></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">On January 31, 2018, the Company issued a press release announcing
that the U.S. Food and Drug Administration has granted Fast Track designation to pegunigalsidase alfa, or PRX-102, the Company&rsquo;s
plant cell-expressed recombinant, pegylated, cross-linked &alpha;-galactosidase-A candidate for the treatment of Fabry disease.
A copy of the press release is attached as Exhibit&nbsp;99.1 to this Current Report on Form 8-K and is incorporated herein by reference.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<TR STYLE="vertical-align: top">
    <TD STYLE="width: 11%; padding: 0; text-indent: 0"><FONT STYLE="font-size: 10pt"><B>Item 9.01.</B></FONT></TD>
    <TD STYLE="width: 89%; padding: 0; text-indent: 0"><P STYLE="margin-top: 0; margin-bottom: 0"><FONT STYLE="font-size: 10pt"><B>Financial Statements and Exhibits</B></FONT></P>
                                                       <P STYLE="margin-top: 0; margin-bottom: 0"><FONT STYLE="font-size: 10pt"><B>&nbsp;</B></FONT></P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding: 0; text-indent: 0"><FONT STYLE="font-size: 10pt"><B>(d)</B></FONT></TD>
    <TD STYLE="padding: 0; text-indent: 0"><P STYLE="margin-top: 0; margin-bottom: 0"><FONT STYLE="font-size: 10pt"><B>Exhibits</B></FONT></P>
                                           <P STYLE="margin-top: 0; margin-bottom: 0"><FONT STYLE="font-size: 10pt"><B>&nbsp;</B></FONT></P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="padding: 0; text-indent: 0"><A HREF="tv484489_ex99-1.htm" STYLE="-sec-extract: exhibit"><FONT STYLE="font-size: 10pt">99.1</FONT></A></TD>
    <TD STYLE="padding: 0; text-indent: 0"><A HREF="tv484489_ex99-1.htm" STYLE="-sec-extract: exhibit"><FONT STYLE="font-size: 10pt">Press release dated January 31, 2018.</FONT></A></TD></TR>
</TABLE>

<P STYLE="margin-top: 0; margin-bottom: 0">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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<TR>
    <TD STYLE="text-align: justify; padding: 0; text-indent: 0"><FONT STYLE="font-size: 10pt">&nbsp;Date: January 31, 2018</FONT></TD>
    <TD COLSPAN="3" STYLE="text-align: justify; padding: 0; text-indent: 0"><FONT STYLE="font-size: 10pt"><B>PROTALIX BIOTHERAPEUTICS, INC.</B></FONT></TD></TR>
<TR>
    <TD STYLE="text-align: justify; padding: 0; text-indent: 0">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="text-align: justify; padding: 0; text-indent: 0">&nbsp;</TD></TR>
<TR>
    <TD STYLE="padding: 0; text-align: justify; text-indent: 0">&nbsp;</TD>
    <TD STYLE="padding: 0; text-align: justify; text-indent: 0"><FONT STYLE="font-size: 10pt">By:</FONT></TD>
    <TD COLSPAN="2" STYLE="border-bottom: Black 1pt solid; text-align: justify; padding: 0; text-indent: 0"><FONT STYLE="font-size: 10pt"><U STYLE="text-decoration: none">/s/ Moshe Manor&#9;</U></FONT></TD></TR>
<TR>
    <TD STYLE="text-align: justify; padding: 0; text-indent: 0; width: 60%">&nbsp;</TD>
    <TD STYLE="text-align: justify; padding: 0; text-indent: 0; width: 3%">&nbsp;</TD>
    <TD STYLE="padding: 0; text-indent: 0; width: 5%">Name:</TD>
    <TD STYLE="padding: 0; text-indent: 0; width: 32%">Moshe Manor</TD></TR>
<TR>
    <TD STYLE="text-align: justify; padding: 0; text-indent: 0">&nbsp;</TD>
    <TD STYLE="text-align: justify; padding: 0; text-indent: 0">&nbsp;</TD>
    <TD STYLE="padding: 0; text-indent: 0">Title:</TD>
    <TD STYLE="padding: 0; text-indent: 0"> President and</TD></TR>
<TR>
    <TD STYLE="text-align: justify; padding: 0; text-indent: 0">&nbsp;</TD>
    <TD STYLE="text-align: justify; padding: 0; text-indent: 0">&nbsp;</TD>
    <TD STYLE="padding: 0; text-indent: 0">&nbsp;</TD>
    <TD STYLE="padding: 0; text-indent: 0">Chief Executive Officer</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 3.5in; text-align: justify; text-indent: -3.5in">&nbsp;</P>


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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>tv484489_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><B>Exhibit 99.1</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; color: #222222"><B>Protalix BioTherapeutics&rsquo;
pegunigalsidase alfa Receives Fast Track Designation<BR>
from the U.S. Food and Drug Administration</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; color: #333333"><I>&nbsp;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; color: #333333"><I>Fast Track designation
highlights high unmet medical need in the treatment of Fabry disease</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">CARMIEL,&nbsp;Israel,&nbsp;January 31, 2018&nbsp;(GLOBE
NEWSWIRE) --&nbsp;Protalix BioTherapeutics, Inc.&nbsp;(NYSE American:PLX) (TASE:PLX), announced that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation to pegunigalsidase alfa, or PRX-102, the Company&rsquo;s plant cell-expressed recombinant,
pegylated, cross-linked &alpha;-galactosidase-A candidate for the treatment of Fabry disease. The FDA&rsquo;s Fast Track designation
is a process designed to facilitate the development and expedite the review of drugs and vaccines for serious conditions that fill
an unmet medical need.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">&ldquo;We are very pleased that the FDA has
recognized the potential for pegunigalsidase alfa to fill an unmet need for Fabry patients,&rdquo; said Moshe Manor, Protalix&rsquo;s
President and Chief Executive Officer. The data generated in our clinical trials of pegunigalsidase alfa thus far, as well as nonclinical
data, as presented to the FDA with Protalix&rsquo;s application for Fast Track designation, demonstrate that pegunigalsidase alfa
has the potential to address an unmet medical need for Fabry patients, such as the prevention of renal failure, improved survivability
and a positive impact on quality of life. &ldquo;We believe that Fast Track designation will help facilitate our development program
for pegunigalsidase alfa and may shorten the timelines to an anticipated approval, which will greatly benefit Fabry patients.&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">According to the FDA, Fast Track designation
is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical
need, the purpose being to make important new drugs available to patients earlier. A drug that receives Fast Track designation
from the FDA is eligible for some or all of the following:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; color: #333333"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>More frequent meetings with the FDA to discuss the drug&rsquo;s development plan and ensure collection of appropriate data
needed to support drug approval;</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Times New Roman, Times, Serif">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; color: #333333"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>More frequent written communication from the FDA about such things as the design of the proposed clinical trials;</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Times New Roman, Times, Serif">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; color: #333333"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>Eligibility for the FDA&rsquo;s Accelerated Approval and Priority Review, if relevant criteria are met; and</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Times New Roman, Times, Serif">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; color: #333333"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD>Eligibility for Rolling Review, which allows a drug company to submit completed sections of its Biologic License Application
(BLA) <FONT STYLE="font-family: Times New Roman, Times, Serif">or </FONT>New Drug Application (NDA) for review by the FDA, rather
than waiting until every section of the BLA or NDA is completed before the entire application can be reviewed. BLA or NDA review
usually does not begin until the drug company has submitted the entire application to the FDA.</TD></TR></TABLE>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt; font: 10pt Times New Roman, Times, Serif">&nbsp;</P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">Fabry disease is a serious, life-threatening
condition. It is a disease or condition associated with morbidity that has a substantial impact on survival, day-to-day function,
and the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. Fabry
disease is an X-linked multisystem lysosomal storage disorder caused by the absence or reduction of &alpha;-galactosidase-A (&alpha;-Gal-A)
activity, which is a lysosomal enzyme that catalyzes the hydrolysis of globotriaosylceramide (Gb3) from oligosaccharides, glycoproteins
and glycolipids. The absence or reduction of this enzymatic activity leads to the progressive accumulation of glycolipids, especially
Gb3, in capillary endothelial cells, podocytes, tubular cells, glomerular endothelial cells, mesangial cells, interstitial cells,
cardiomyocytes, fibroblasts, and neurons. The accumulation of glycosphingolipids (e.g., Gb3) leads to chronic pain, skin lesions,
cardiac, deficiencies, and, in particular, renal involvement. End-stage renal failure and cardiomyopathy often lead to early death
in Fabry patients. Fabry disease causes substantial reduction in life-expectancy, by an average of 15 years in female patients
and 20 years in male patients, compared to the general population.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">Pegunigalsidase alfa is currently being studied
globally in three phase III clinical trials. Enrollment in each of the trials continues to progress and estimated timelines for
top-line data announcements will be announced upon completion of enrollment for each individual trial.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333"><B>About&nbsp;Protalix BioTherapeutics, Inc.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333">Protalix is a biopharmaceutical
company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary
plant cell-based expression system, ProCellEx&reg;.&nbsp; Protalix&rsquo;s unique expression system presents a proprietary method
for developing recombinant proteins in a cost-effective, industrial-scale manner.&nbsp; Protalix&rsquo;s first product manufactured
by ProCellEx, taliglucerase alfa, was approved for marketing by the&nbsp;U.S. Food and Drug Administration&nbsp;(FDA) in&nbsp;May
2012&nbsp;and, subsequently, by the regulatory authorities of other countries.&nbsp; Protalix has licensed to&nbsp;Pfizer Inc.&nbsp;the
worldwide development and commercialization rights for taliglucerase alfa, excluding&nbsp;Brazil, where Protalix retains full rights.&nbsp;
Protalix&rsquo;s development pipeline includes the following product candidates: pegunigalsidase alfa, a modified version of the
recombinant human alpha-GAL-A protein for the treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment;
alidornase alfa for the treatment of Cystic Fibrosis; and others.&nbsp; Protalix has entered into an ex-United States&nbsp;partnership
with Chiesi Farmaceutici S.p.A. for the development and commercialization of pegunigalsidase alfa.&nbsp; Protalix maintains full
rights to pegunigalsidase alfa in&nbsp;the&nbsp;United States.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333"><B>Forward-Looking
Statements</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333">To the extent that
statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to
the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.&nbsp; The terms &ldquo;expect,&rdquo; &ldquo;anticipate,&rdquo;
&ldquo;believe,&rdquo; &ldquo;estimate,&rdquo; &ldquo;project,&rdquo; &ldquo;plan,&rdquo; &ldquo;should&rdquo; and &ldquo;intend&rdquo;
and other words or phrases of similar import are intended to identify forward-looking statements.&nbsp; These forward-looking statements
are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially
from the statements made.&nbsp; These statements are based on our current beliefs and expectations as to such future outcomes.&nbsp;
Drug discovery and development involve a high degree of risk.&nbsp; Factors that might cause material differences include, among
others: the risk that despite the FDA&rsquo;s grant of Fast Track designation for pegunigalsidase alfa for the treatment of Fabry
disease, we may not experience a faster development process, review or approval compared to applications considered for approval
under conventional FDA procedures; risks related to the FDA&rsquo;s ability to withdraw the Fast Track designation at any time;
failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several factors,
including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of
effectiveness during clinical trials; inability to monitor patients adequately during or after treatment; risks related to our
ability to maintain and manage our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks
related to the amount and sufficiency of our cash and cash equivalents; risks related to the amount of our future revenues, operations
and expenditures; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols;
and lack of sufficient funding to finance clinical trials; the risk that the results of the clinical trials of our product candidates
will not support our claims of superiority, safety or efficacy, that our product candidates will not have the desired effects or
will be associated with undesirable side effects or other unexpected characteristics; risks relating to our ability to make scheduled
payments of the principal of, to pay interest on or to refinance our outstanding notes or any other indebtedness; our dependence
on performance by third party providers of services and supplies, including without limitation, clinical trial services; delays
in our preparation and filing of applications for regulatory approval; delays in the approval or potential rejection of any applications
we file with the&nbsp;FDA&nbsp;or other health regulatory authorities, and other risks relating to the review process; our ability
to identify suitable product candidates and to complete preclinical studies of such product candidates; the inherent risks and
uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies
and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels
of product liability and other necessary insurance coverage; and other factors described in our filings with the&nbsp;U.S. Securities
and Exchange Commission.&nbsp; The statements in this press release are valid only as of the date hereof and we disclaim any obligation
to update this information, except as may be required by law.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333"><B>Investor Contact</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333">Marcy Nanus<BR>
Solebury Trout<BR>
646-378-2927<BR>
<U>mnanus@troutgroup.com</U>&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white; color: #333333">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -0.35pt; color: #333333"><B>Source:&nbsp;Protalix
BioTherapeutics, Inc.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -0.35pt; color: #333333"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: -0.35pt; color: #333333"><B></B></P>

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