- September 13, 2021
- Posted by: Mainframe Consulting
- Category: Business Wire
SAN DIEGO–(BUSINESS WIRE)–Shareholder rights law firm Robbins LLP reminds investors that a class action has been filed on behalf of all purchasers of CorMedix Inc. (NASDAQ: CRMD) between July 8, 2020 and May 13, 2021, for violations of the Securities Exchange Act of 1934. CorMedix is a biopharmaceutical company that develops and commercializes therapeutic products for the prevention and treatment of infectious and inflammatory diseases in the U.S. and internationally. CorMedix’s lead product candidate is DefenCath, a novel antibacterial and antifungal solution designed to prevent costly and dangerous catheter-related bloodstream infections (“CRBSIs”).
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. All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
If you suffered a loss due to CorMedix Inc.’s misconduct, click here.
CorMedix Inc. (CRMD) Failed to Disclose Deficiencies in the Manufacturing Process of its Lead Product Candidate
According to the complaint, 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that the “FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.”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.
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Published at Mon, 13 Sep 2021 19:08:00 +0000