CorMedix Inc.

In July 2020, CorMedix filed its New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for DefenCath, an antibacterial and antifungal solution, as a catheter lock solution with an initial indication for use of preventing certain catheter-related bloodstream infections.

On March 1, 2021, CorMedix announced the NDA would not be approved “in its present form” due to “concerns at the third-party manufacturing facility.” Moreover, the FDA “is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.”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, CorMedix announced it 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.

Then, 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.”  Among other things, the Company was required  “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.” 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.

Then, on September 7, 2021, before the market opened, CorMedix disclosed that it has “encountered delays at its third-party contract manufacturer,” and was informed there are other issues at the contract manufacturer “unrelated to DefenCath manufacturing activities.” On this news, CorMedix’s share price has fallen approximately 20% during intra-day trading on September 7, 2021, thereby further injuring investors.

The complaint filed in this class action 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 failed to disclose to investors 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, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.