Current Report Filing (8-k)
April 15 2021 - 10:04AM
Edgar (US Regulatory)
0001410098
false
0001410098
2021-04-14
2021-04-14
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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):
April 14, 2021
CORMEDIX INC.
(Exact name of registrant as specified in its charter)
Delaware
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001-34673
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20-5894890
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(State or other jurisdiction of
incorporation or organization)
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(Commission File Number)
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(I.R.S. Employer
Identification No.)
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300 Connell Drive, Suite 4200
Berkeley Heights, NJ
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07922
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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: (908) 517-9500
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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Securities registered pursuant to Section 12(b) of the Exchange 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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CRMD
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The Nasdaq Stock Market LLC
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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 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
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 April 14, 2021, CorMedix Inc. (the “Company”) issued a press
release announcing that it has met with the US Food and Drug Administration (the “FDA”) to discuss proposed resolutions for
the deficiencies identified in the FDA’s Complete Response Letter to the Company and the Post-Application Action Letter received
by the third-party manufacturer (CMO) from the FDA for the New Drug Application for DefenCath™.
A copy of the press release is filed as Exhibit 99.1 to this Current Report
on Form 8-K and is incorporated herein by reference.
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Item 9.01.
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Financial Statements and Exhibits
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(d) Exhibits
SIGNATURE
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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CORMEDIX INC.
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Date: April 15, 2021
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By:
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/s/ Khoso Baluch
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Name:
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Khoso Baluch
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Title:
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Chief Executive Officer
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3
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