Current Report Filing (8-k)
June 06 2019 - 7:11AM
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): June 6, 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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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 communication 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))
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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
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¨
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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.
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On
June
6
, 2019, Protalix BioTherapeutics, Inc. (the “Company”)
and its commercialization partner, Chiesi Farmaceutici S.p.A., issued a joint press release announcing
that
they plan to file a biologics license application for pegunigalsidase alfa for the treatment of Fabry disease in the first quarter
of 2020 via the accelerated approval pathway of the U.S. Food and Drug Administration.
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.
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: June
6
, 2019
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PROTALIX BIOTHERAPEUTICS, INC.
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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
Chief Executive Officer
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