San Diego, California–(Newsfile Corp. – July 27, 2021) – The CorMedix class action lawsuit charges CorMedix Inc. (NASDAQ: CRMD) and certain of its top executives with violations of the Securities Exchange Act of 1934 and seeks to represent purchasers of CorMedix securities between July 8, 2020 and May 13, 2021, inclusive (“Class Period”). The CorMedix class action lawsuit (Patrick v. CorMedix Inc., No. 21-cv-14020) was commenced on July 22, 2021 in the District of New Jersey and is assigned to Judge Julien X. Neals.

If you wish to serve as lead plaintiff of the CorMedix class action lawsuit, please provide your information by clicking here. You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at [email protected]. Lead plaintiff motions for the CorMedix class action lawsuit must be filed with the court no later than September 20, 2021.

CASE ALLEGATIONS: The CorMedix class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and failed to disclose that: (i) deficiencies existed with respect to CorMedix’s lead product candidate DefenCath’s manufacturing process and/or at the facility responsible for manufacturing DefenCath; (ii) in light of the foregoing deficiencies, the U.S. Food and Drug Administration (“FDA”) was unlikely to approve the DefenCath New Drug Application (“NDA”) for catheter-related bloodstream infections (“CRBSIs”) in its present form; (iii) defendants had downplayed the true scope of the deficiencies with DefenCath’s manufacturing process and/or at the facility responsible for manufacturing DefenCath; and (iv) as a result, CorMedix’s public statements were materially false and misleading at all relevant times.

On March 1, 2021, CorMedix issued a press release “announc[ing] that the [FDA] cannot approve the [NDA] for DefenCath . . . in its present form.” CorMedix informed investors that the “FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility”; that the “FDA did not specify the issues and CorMedix intends to work with the manufacturing facility to develop a plan for resolution when FDA informs the facility of the specific concerns”; that, “[w]hen we are informed of the issues, we will schedule an investor conference call to provide an update on our expected timeline for resolution”; and that “[a]dditionally, 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 fell nearly 40%.

Then, on April 14, 2021, CorMedix announced that it would have to take additional steps to meet the FDA’s requirements for DefenCath’s manufacturing process, including “[a]ddressing [the] 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 fell more than 15%.

Finally, 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 [the] FDA.” After an analyst pressed for clearer information on DefenCath’s manufacturing deficiencies on a conference call held that same day, CorMedix’s Executive Vice President and General Counsel, defendant Phoebe Mounts, disclosed among other things that “there are times when there may be unexpected results obtained”; that the FDA “expect[s] us 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”; that “sterility is a very important part of that process,” as well as “the accuracy in making sure the right volume of DefenCath is loaded into the vials”; that “we’re talking about thousands of vials during the manufacturing run”; that CorMedix must “generat[e] a lot of data to make sure that . . . all the equipment has been qualified for the intended use and every step in the manufacturing process has been qualified”; that “th[e] process needs to be very robust, [and] needs to be reproducible”; and that “the burden is on the manufacturer to demonstrate that the facility can do that process reducibly and generate the required product for commercial distribution.” On this news, CorMedix’s stock price fell an additional 20%, further damaging investors.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased CorMedix securities during the Class Period to seek appointment as lead plaintiff in the CorMedix class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the CorMedix class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the CorMedix class action lawsuit. An investor’s ability to share in any potential future recovery of the CorMedix class action lawsuit is not dependent upon serving as lead plaintiff.

ABOUT ROBBINS GELLER RUDMAN & DOWD LLP: With 200 lawyers in 9 offices nationwide, Robbins Geller Rudman & Dowd LLP is the largest U.S. law firm representing investors in securities class actions. Robbins Geller attorneys have obtained many of the largest shareholder recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig. The 2020 ISS Securities Class Action Services Top 50 Report ranked Robbins Geller first for recovering $1.6 billion for investors last year, more than double the amount recovered by any other securities plaintiffs’ firm. Please visit https://www.rgrdlaw.com/firm.html for more information.

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Contact:
Robbins Geller Rudman & Dowd LLP
655 W. Broadway, San Diego, CA 92101
J.C. Sanchez, 800-449-4900
[email protected]

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/91248