The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of New Jersey on behalf of those who acquired CorMedix Inc. (“CorMedix” or the “Company”) (NASDAQ: CRMD) securities from July 8, 2020 through May 13, 2021, inclusive (the “Class Period”). Investors have until September 20, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

CorMedix is a biopharmaceutical company that focuses on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases in the United States and internationally. The Company is focused on developing its lead product candidate, DefenCath, a purported novel antibacterial and antifungal solution designed to prevent costly and dangerous catheter-related bloodstream infections (“CRBSIs”).

In July 2020, CorMedix filed its New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for DefenCath, an antibacterial and antifungal solution, as a catheter lock solution with an initial indication for use of preventing certain catheter-related bloodstream infections.

On March 1, 2021, CorMedix announced the NDA would not be approved “in its present form” due to “concerns at the third-party manufacturing facility.” Moreover, the FDA “is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.” On this news, CorMedix’s stock price declined by $5.98 per share, or approximately 39.87%, from $15.00 per share to close at $9.02 per share on March 1, 2021.

Then, on April 14, 2021, CorMedix announced it would have to take additional steps to meet the FDA’s requirements for DefenCath’s manufacturing process, including “[a]ddressing FDA’s concerns regarding the qualification of the filling operation [that] may necessitate adjustments in the process and generation of additional data on operating parameters for manufacture of DefenCath.” On this news, CorMedix’s stock price declined by $1.44 per share, or approximately 15.37%, from $9.37 per share to close at $7.93 per share on April 14, 2021.

Then, on May 13, 2021, CorMedix announced that “[b]ased on our analyses, we have concluded that additional process qualification will be needed with subsequent validation to address the deficiencies identified by FDA.” Among other things, the Company was required “to generate sufficient data to demonstrate that [the filling] process is a controlled process and is consistent with the agency’s requirements for good manufacturing practice.” On this news, CorMedix’s stock price declined by $1.51 per share, or approximately 19.97%, from $7.56 per share to close at $6.05 per share on May 14, 2021.

The lawsuit alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors the following: (1) deficiencies existed with respect to DefenCath’s manufacturing process and/or at the facility responsible for manufacturing DefenCath; (2) in light of the foregoing deficiencies, the FDA was unlikely to approve the DefenCath NDA for CRBSIs in its present form; (3) Defendants had downplayed the true scope of the deficiencies with DefenCath’s manufacturing process and/or at the facility responsible for manufacturing DefenCath; and (4) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.

If you purchased or otherwise acquired CorMedix securities, have information, or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney LLP at 212-371-6600, by email at investigations@kmllp.com, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.

Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website: http://www.kmllp.com.

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