Kaskela Law LLC is investigating CorMedix Inc. (“CorMedix” or the “Company”) (NASDAQ: CRMD) on behalf of the Company’s long-term investors.
Recently an amended securities fraud complaint was filed against CorMedix on behalf of certain investors who purchased shares of the Company’s common stock between October 16, 2019 and September 6, 2021.
According to the complaint, during that time period CorMedix and certain of the Company’s executive officers issued a series of materially false and misleading statements to investors about the Company’s business, operations and prospects. Among other things, the complaint alleges that defendants failed to disclose that (i) deficiencies existed at the facility manufacturing DefenCath and/or with respect to the process for withdrawing the labeled volume from the vials such that the fill volume was inconsistent; (ii) the DefenCath’s New Drug Application (“NDA”) reflected those deficiencies; and (iii) in light of the foregoing deficiencies, the FDA was unlikely to approve the DefenCath NDA.
On March 1, 2021, CorMedix issued a press release disclosing that it had received a Complete Response Letter (“CRL”) from the FDA. As detailed in the complaint, that press release disclosed 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.” On this news, shares of the Company’s stock fell $5.98 per share, or 40% in value, to close at $9.02 per share on March 1, 2021, on heavy trading volume.
Subsequently, on September 7, 2021, CorMedix disclosed that it “has encountered delays at its third-party [commercial manufacturing organization (“CMO”)]” relating to “issues that are unrelated to DefenCath manufacturing activities” and that “the timeline for CorMedix and the CMO to address deficiencies at the facility that are required for resubmission of the DefenCath NDA is uncertain[.]” On this additional news, shares of the Company’s stock fell an additional $1.45 per share, or 22.5% in value, to close on September 7, 2021 at $5.01 per share, again on heavy trading volume.
CorMedix stockholders who purchased or acquired shares of the Company’s stock prior to October 16, 2019 are encouraged to contact Kaskela Law LLC (Adrienne Bell, Esq.) at (484) 229 – 0750, or by completing the form on this page, to receive additional information about this investigation and their legal rights and options.