Current Report Filing (8-k)
October 17 2019 - 8:43AM
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): October 17, 2019
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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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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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. ☐
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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Item 8.01 Other Events
On October 17, 2019, Protalix BioTherapeutics, Inc. (the
“Company”) issued a press release announcing positive 12-month on-treatment data from the first 16 out of the 22 adult
patients enrolled in its BRIDGE Phase III study, an open label switch-over study evaluating the safety and efficacy of pegunigalsidase
alfa (PRX-102), 1 mg/kg infused every two weeks, in up to 22 Fabry patients currently treated with agalsidase alfa (Replagal®)
for at least two years and on a stable dose for at least six months. Pegunigalsidase alfa is the Company’s plant cell-expressed
recombinant, PEGylated, cross-linked α-galactosidase-A
drug candidate. 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 Financial Statements and Exhibits
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: October 17, 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: Dror Bashan
Title: President and Chief Executive Officer
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