CORMEDIX ALERT: Investors With Substantial Losses Have Opportunity to Lead the CorMedix Inc. Class Action Lawsuit

SAN DIEGO, July 26, 2021 / PRNewswire / – The CorMedix class action lawsuit accuses CorMedix Inc. (NASDAQ: CRMD) and some of its top executives for violating the Securities Exchange Act of 1934 and attempting to intercept buyers of CorMedix securities July 8, 2020 and May 13, 2021, including (“Class Period”). The CorMedix class action lawsuit was initiated on July 22, 2021 in the district New Jersey and is headed Patrick v. CorMedix Inc., No. 21-cv-14020.

Robbins Geller represents US and international institutional investors in emergency securities and corporate disputes with 200 attorneys in ten offices. The company has received many of the largest security class action recoveries in history, including the largest securities class action judgment. Please visit https://www.rgrdlaw.com for more information. (PRNewsFoto / Robbins Geller Rudman & Dowd LLP)

If you would like to act as the lead plaintiff in the CorMedix class action, please provide your information by clicking here. You can also contact Attorney JC Sanchez of Robbins Geller by phone at 800 / 449-4900 or by email at jsanchez@rgrdlaw.com. Motions by the lead plaintiffs for the CorMedix class action must be submitted by be submitted to the court September 20, 2021.

CASE ALLEGES: The CorMedix class action claims that defendants made false and misleading statements during the class action period and failed to disclose: (i) Defects in the manufacturing process of CorMedix’s lead product candidate DefenCath and / or in the facility responsible for manufacturing DefenCath ; (ii) In view of the foregoing deficiencies, it was unlikely that the United States Food and Drug Administration (“FDA”) would approve the DefenCath New Drug Application (“NDA”) for Catheter-Related Infections in its current form; (iii) Defendants downplayed the true extent of the defects in DefenCath’s manufacturing process and / or in the facility responsible for manufacturing DefenCath; and (iv) as a result, CorMedix’s public statements at all relevant times have been materially false and misleading.

on March 1, 2021, CorMedix released an “announce” press release[ing] that the [FDA] can’t approve of that [NDA] for DefenCath. . . in its current form. “CorMedix informed investors that the” FDA has identified concerns about the third party manufacturing facility after reviewing the records requested by the FDA and provided by the manufacturing facility “; that the” FDA has not specified the issues and CorMedix intends to Work with the manufacturing facility to develop a plan of action if the FDA notifies the manufacturing facility of the specific concern “; that”[w]As soon as we are informed of the problems, we will schedule an investor conference call to provide information on our expected timeline for the resolution “; and that”[a]In addition, the FDA is requesting a manual extraction study to show that despite an in-process control in place, the marked volume can be consistently removed from the vial to demonstrate the fill volume is within specifications. “Because of this news, the stock price fell from CorMedix by almost 40%.

The story goes on

Then, on April 14, 2021CorMedix announced that it needs to take additional steps to meet FDA requirements for the DefenCath manufacturing process, including “[a]dress up [the] FDA concerns about the qualification of the filling process [that] may require adjustments in the process and the generation of additional data on operating parameters for the production of DefenCath. “As a result of this news, the CorMedix share price fell by more than 15%.

Finally on May 13, 2021, CorMedix announced that “[b]Based on our analyzes, we have come to the conclusion that additional process qualification with subsequent validation is required in order to remedy the identified deficiencies [the] FDA. “After an analyst called for clearer information about DefenCath’s manufacturing defects in a conference call that day, CorMedix became Executive Vice President and General Counsel Phoebe mounts, revealed, among other things, that “sometimes unexpected results can be achieved”; that the FDA “expects”[s] us to generate enough data to demonstrate that [the filling] Process is a controlled process and consistent with good manufacturing practice requirements “that” sterility is a very important part of this process “and” the accuracy to ensure that the correct amount of DefenCath is loaded into the vials “. “; that “we are talking about thousands of vials in the manufacturing run”; that CorMedix has to “generate”[e] lots of data to make sure of that. . . all equipment has been qualified for its intended use and every step in the manufacturing process has been qualified “; that” this[e] Process must be very robust [and] must be reproducible “and that” the burden is on the manufacturer to prove that the plant can perform this process in a reducible way and manufacture the required product for commercial distribution. “As a result of this news, the CorMedix share price fell by a further 20%, which is further Damaged investors.

LEAD ACTION: The Private Securities Litigation Reform Act of 1995 allows any investor who acquired CorMedix securities during the class action period to be named as the lead plaintiff in the CorMedix class action. A lead plaintiff is usually the applicant with the greatest financial interest in the legal protection sought by the alleged class, which is also typical and appropriate for the alleged class. A lead plaintiff is acting on behalf of all other group members in leading the CorMedix class action lawsuit. The lead plaintiff can choose a law firm of their choice to bring the CorMedix class action lawsuit. An investor’s ability to participate in a possible future CorMedix class action lawsuit does not depend on being the lead plaintiff.

ABOUT ROBBINS GELLER RUDMAN & DOWD LLP: With 200 attorneys in 9 offices across the country, Robbins Geller Rudman & Dowd LLP is the largest US law firm serving investors in securities class actions. Robbins Geller’s attorneys have achieved many of the largest shareholder reclaims in history, including the largest stock class recovery reclaim of all time – $ 7.2 billion – in relation to Enron Corp. Sec. Lit. Robbins Geller was ranked # 1 in recovery in the 2020 ISS Securities Class Action Services Top 50 Report $ 1.6 billion for investors in the past year, more than double the amount collected from all other securities plaintiffs. 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

JC Sanchez, 800-449-4900

jsanchez@rgrdlaw.com

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SOURCE Robbins Geller Rudman & Dowd LLP

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