Current Report Filing (8-k)
18 November 2019 - 10:57PM
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): November 18, 2019
Protalix
BioTherapeutics, Inc.
(Exact name of registrant as specified
in its charter)
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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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Science Park, POB 455
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Carmiel, Israel
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20100
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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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¨
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Written communication 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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Securities registered pursuant to Section
12(b) of the Act:
Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common stock, $0.001 par value
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PLX
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NYSE American
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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 §230.405) or Rule 12b-2 of the Securities
Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth
company ¨
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. ¨
On November 18, 2019, Protalix BioTherapeutics, Inc. (the
“Company”) issued a press release announcing, together with its development and commercialization partner, Chiesi
Farmaceutici S.p.A., that they have completed a successful Type B Pre-Biologics License Application (BLA) meeting with the U.S. Food
and Drug Administration (FDA) regarding the Accelerated Approval pathway for pegunigalsidase alfa (PRX-102) for the treatment
of Fabry disease. Pegunigalsidase alfa is the Company’s investigational, plant cell culture expressed, and chemically modified
stabilized version of, the recombinant alpha-Galactosidase-A enzyme. A copy of the press release is attached as Exhibit 99.1
to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01
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Financial Statements and Exhibits
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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.
Date: November 18, 2019
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PROTALIX BIOTHERAPEUTICS, INC.
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By:
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/s/ Dror
Bashan
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Name:
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Dror Bashan
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Title:
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President and
Chief Executive Officer
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