CorMedix Inc. (“CorMedix” or the “Company”) is a biopharmaceutical company that focuses on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases in the U.S. and internationally. The Company is focused on developing its lead product candidate, DefenCath, a purported novel antibacterial and antifungal solution designed to prevent costly and dangerous catheter-related bloodstream infections.
On March 1, 2021, CorMedix issued a press release “announc[ing] that the [FDA] cannot approve the [NDA] for DefenCath . . . 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”; that the “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”; and that, “[w]hen we are informed of the issues, we will schedule an investor conference call to provide an update on our expected timeline for resolution.”
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, the Company announced that CorMedix would have to take additional steps to meet the FDA’s requirements for DefenCath’s manufacturing process, and that it “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.
A securities class action has been filed against CorMedix on behalf of shareholders that purchased 360 CorMedix shares between July 8, 2020 through May 13, 2021. This case has been filed in the U.S. District Court for the District of New Jersey.
The complaint filed 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 that: (i) deficiencies existed with respect to DefenCath’s manufacturing process and/or at the facility responsible for manufacturing DefenCath; (ii) in light of the foregoing deficiencies, the FDA was unlikely to approve the DefenCath NDA for catheter-related bloodstream infections in its present form; (iii) the Company had downplayed the true scope of the deficiencies with DefenCath’s manufacturing process and/or at the facility responsible for manufacturing DefenCath; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.
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