Press release content from Globe Newswire. The AP news staff was not involved in its creation.
NEW YORK, July 23, 2021 (GLOBE NEWSWIRE) — Gainey McKenna & Egleston announces that a class action lawsuit has been filed against CorMedix Inc. (“CorMedix” or the “Company”) (NASDAQ: CRMD) in the United States District Court for the District of New Jersey on behalf of those who purchased or otherwise acquired CorMedix publicly traded securities between July 8, 2020 and May 13, 2021, inclusive (the “Class Period”).
The Complaint alleges that Defendants made material misrepresentations concerning 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, the Company’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“[a]dditionally, FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.”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 $5.98 per share, or 39.87%, to close at $9.02 per share on March 1, 2021.
Then, on April 14, 2021, Defendants announced that CorMedix 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 fell $1.44 per share, or 15.37%, to close at $7.93 per share on April 14, 2021.
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 FDA.” After an analyst pressed for clearer information on DefenCath’s manufacturing deficiencies on a conference call held that same day, Phoebe Mounts, CorMedix’s Executive Vice President and General Counsel, finally disclosed, inter alia, 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 are talking about thousands of vials during the manufacturing run”; that Defendant must “generat[e] of 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 $1.51 per share, or 19.97%, to close at $6.05 per share on May 14, 2021.
Investors who purchased or otherwise acquired shares of CorMedix during the Class Period should contact the Firm prior to the September 20, 2021 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at [email protected] or [email protected].
Please visit our website at http://www.gme-law.com for more information about the firm.