CorMedix Inc. (CRMD)
Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of CorMedix Inc. ("CorMedix" or "the Company") (NASDAQ: CRMD). The investigation concerns whether CorMedix and certain of its officers and/or directors have violated federal securities laws.
On March 1, 2021, CorMedix issued a press release “announc[ing] that the US Food and Drug Administration (FDA) cannot approve the New Drug Application (NDA) for DefenCath™ (taurolidine/heparin catheter lock solution) 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. 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. When we are informed of the issues, we will schedule an investor conference call to provide an update on our expected timeline for resolution. Additionally, FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.”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.
If you are aware of any facts relating to this investigation, or purchased CorMedix shares, you can assist this investigation by visiting contacting the firm. You can also contact Peretz Bronstein or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484.
Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique. Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients. In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm’s expertise includes general corporate and commercial litigation, as well as securities arbitration. Attorney advertising. Prior results do not guarantee similar outcomes.