Cormedix inc.
Exchange: NASDAQ
Ticker: CRMD
Date of Filing: 07/22/2021
Court: New Jersey District Court
Filing Deadline

09/20/2021

Cormedix Inc.

Cormedix Inc Stock drops and Case is Filed

A complaint was filed on July 22, 2021 against Cormedix Inc. The complaint 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 made material misrepresentations concerning the following: (i) deficiencies existed with respect to DefenCath’s manufacturing process and/or at the facility responsible for manufacturing DefenCath; (ii) in light of the foregoing deficiencies, the FDA was unlikely to approve the DefenCath NDA for 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, 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“[a]dditionally, FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.”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.

 


For More information  as well as to join this case please contact Atara Twersky, Esq. at [email protected] or [email protected].  Atara is Principal at Twersky Law Group and Of counsel at AF&T law firm where she is director of Investor Services.  Atara focuses her practice on assisting her clients with increasing their investment portfolio recoveries and ensuring that their portfolios remain healthy and robust.  For more information on shareholder recoveries click here and to listen to Atara’s podcast with notable guests in the Pension fund Industry listen to Pension and Investments Podcast, on all matters related to your investment portfolio and more. For more information on  Atara and her legal work connected to shareholder protection click here

DOCUMENTS


COMPLAINT

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