Current Report Filing (8-k)
August 09 2022 - 09:04AM
Edgar (US Regulatory)
0001410098 false 0001410098 2022-08-08
2022-08-08 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):
August 8, 2022
CORMEDIX INC.
(Exact
name of registrant as specified in its charter)
|
Delaware |
|
001-34673 |
|
20-5894890 |
|
(State
or other jurisdiction of
incorporation
or organization)
|
|
(Commission
File Number) |
|
(I.R.S.
Employer
Identification
No.)
|
|
300 Connell Drive,
Suite 4200
Berkeley Heights,
NJ
|
|
07922 |
|
(Address
of principal executive offices) |
|
(Zip
Code) |
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):
|
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425) |
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12) |
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b)) |
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Exchange
Act:
|
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
|
Common stock, $0.001 par value |
|
CRMD |
|
The Nasdaq Stock Market LLC |
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. ☐
Item
8.01 Other
Events
On
August 8, 2022, CorMedix Inc. (the “Company”) issued a press
release announcing that a second Complete Response Letter was
received from the U.S. Food and Drug Administration (“FDA”),
stating that the New Drug Application (“NDA”) for DefenCath cannot
be approved until the deficiencies conveyed to the contract
manufacturing organization and the supplier of the active
pharmaceutical ingredient heparin during inspections are resolved
to the satisfaction of FDA.
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.
Item
9.01 Financial
Statements and Exhibits
(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.
| |
CORMEDIX
INC. |
|
|
|
|
|
Date:
August 9, 2022 |
By: |
/s/
Joseph
Todisco |
| |
Name: |
Joseph
Todisco |
|
|
Title: |
Chief
Executive Officer |
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