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



Exhibit No.   Description

99.1            Press Release dated August 8, 2022
104           Cover Page Interactive Data File (embedded within the Inline XBRL document)




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