Kirby McInerney LLP reminds investors that a class action lawsuit has been filed on behalf of investors in CorMedix Inc. (CRMD) and encourages investors to contact the company by September 20, 2021



NEW YORK, August 06, 2021 (GLOBE NEWSWIRE) – The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the United States 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 to May 13, 2021 inclusive (the “Recourse Period”). Investors have until September 20, 2021 to ask the court to be named lead plaintiffs in the lawsuit.

CorMedix is ​​a biopharmaceutical company focused on the development and commercialization of therapeutic products for the prevention and treatment of infectious and inflammatory diseases in the United States and globally. The Company is focused on the development of its flagship product candidate, DefenCath, a purported new antibacterial and antifungal solution designed to prevent costly and dangerous catheter-related bloodstream infections (“CRBSI”).

In July 2020, CorMedix filed its New Drug Application (“NDA”) with the United States Food and Drug Administration (“FDA”) for DefenCath, an antibacterial and antifungal solution, as a catheter locking solution with an initial indication for use to prevent certain catheter-related blood infections.

On March 1, 2021, CorMedix announced that the NDA would not be approved “in its current form” due to “concerns at the third-party manufacturing facility”. In addition, the FDA “requires a manual extraction study to demonstrate that the labeled volume can be systematically removed from the vials despite an existing in-process control to demonstrate the fill volume within specifications.” Following this news, CorMedix’s share price fell $ 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 that it would need to take additional steps to meet FDA requirements for the manufacturing process of DefenCath, including “[a]address FDA concerns regarding the qualification of the filling operation [that] may require process adjustments and the generation of additional data on operating parameters for manufacturing DefenCath. Following this news, CorMedix’s share price fell $ 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]Based on our analyzes, we concluded that further qualification of the process will be required with subsequent validation to address the deficiencies identified by the FDA. Among other things, the Company was required to “generate sufficient data to demonstrate that [the filling] is a controlled process and complies with the agency’s requirements for good manufacturing practice. Following this news, CorMedix’s share price fell $ 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, the Defendants made materially false and / or misleading statements, and failed to disclose material adverse facts regarding the business, operations and prospects of the Company. Specifically, the Defendants failed to disclose to investors the following: (1) deficiencies existed with respect to the manufacturing process of DefenCath and / or the facility responsible for manufacturing DefenCath; (2) in light of the above shortcomings, it was unlikely that the FDA would approve DefenCath NDA for CRBSIs in its current form; (3) the defendants had downplayed the actual extent of the deficiencies in the manufacturing process of DefenCath and / or the facility responsible for manufacturing DefenCath; and (4) accordingly, the Defendants’ positive statements regarding the business, operations and prospects of the Company were substantially misleading and / or lacked reasonable basis at all relevant times.

If you have purchased or acquired CorMedix securities, have any information or would like to know more about these claims, please contact Thomas W. Elrod of Kirby McInerney LLP at 212-371-6600, by email at [email protected], or by completing this Contact form, to discuss your rights or interests in these matters at no cost to you.

Kirby McInerney LLP is a New York-based plaintiff law firm specializing 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 is available on the Kirby McInerney LLP website: http://www.kmllp.com.

This press release may be considered an attorney’s advertisement in certain jurisdictions under applicable law and ethical rules.

Contacts
Kirby McInerney LLP
Thomas W. Elrod, Esq.
212-371-6600
https://www.kmllp.com
[email protected]


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