CorMedix Inc. (CRMD) Failed to Disclose Deficiencies in the Manufacturing Process of its Lead Product Candidate
CorMedix completed submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for DefenCath. On March 1, 2021, CorMedix announced “that the [FDA] cannot approve the [NDA] for DefenCath … in its present form due to “concerns at the third-party manufacturing facility” that were currently unknown to CorMedix. The announcement also revealed that the “FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.”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, or almost 40%, to close at $9.02 per share on March 1, 2021. Over the next several months, the Company revealed additional set-backs, including the need to make “adjustments in the process” and finally, the need to generate additional data “to address the deficiencies identified by the FDA.” These disclosures have led to a further decline in the stock price, which trades at around $6.23 per share.
If you purchased shares of CorMedix Inc. (CRMD) between July 8, 2020 and May 13, 2021, you have until September 20, 2021, to ask the court to appoint you lead plaintiff for the class.
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