What did the shareholder lawsuits over DefenCath's FDA letters lead to?

CorMedix Form 8-K, filed August 9, 2022

August 8, 2022 CORMEDIX INC. (Exact name of registrant as specified in its charter) Delaware 001-34673 20-5894890 (State or other jurisdiction of incorporation or organization) (Commission File Number) (I.R.S. Employer Identification No.) 300 Connell Drive , Suite 4200 Berkeley Heights , NJ 07922 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: ( 908 ) 517-9500 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2, below): ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Exchange Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock, $0.001 par value CRMD The Nasdaq Stock Market LLC Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Item 8.01 Other Events On August 8, 2022, CorMedix Inc. (the “Company”) issued a press release announcing that a second Complete Response Letter was received from the U.S. Food and Drug Administration (“FDA”), stating that the New Drug Application (“NDA”) for DefenCath cannot be approved until the deficiencies conveyed to the contract manufacturing organization and the supplier of the active pharmaceutical ingredient heparin during inspections are resolved to the satisfaction of FDA.

CorMedix Form 10-K, filed March 5, 2026

In general, the purported bases for these claims are allegedly false and misleading statements and omissions related to the NDA submissions to the FDA for DefenCath, subsequent complete response letters, as well as communications from the FDA related and directed to the Company’s contract manufacturing organization and heparin supplier.

CorMedix Form 10-K, filed March 5, 2026

In the third amended complaint, the Lead Plaintiff seeks to represent a class of shareholders who purchased or otherwise acquired CorMedix securities between October 16, 2019 and August 8, 2022, inclusive.

CorMedix Form 10-K, filed March 5, 2026

On October 13, 2021, the United States District Court for the District of New Jersey consolidated into In re CorMedix Inc. Securities Litigation , Case No. 2:21-cv 14020-JXN-CLW, two putative class action lawsuits filed on or about July 22, 2021 and September 13, 2021, respectively, and appointed lead counsel and lead plaintiff, a purported stockholder of the Company. The lead plaintiff filed a consolidated amended class action complaint on December 14, 2021, alleging violations of Sections 10(b) and 20(a) of the Exchange Act, along with Rule 10b-5 promulgated thereunder, and Sections 11 and 15 of the Securities Act of 1933.

CorMedix Form 10-K, filed March 5, 2026

On August 19, 2025, the Court issued a revised opinion and order, denying the CorMedix Defendants’ motion to dismiss the third amended complaint. Since then, the case has proceeded to discovery.

CorMedix Form 8-K, filed August 7, 2026

On September 23, 2026 , at 10:00 a.m. , at the Martin Luther King Building & U.S. Courthouse, 50 Walnut Street, Newark, NJ 07101, Courtroom 5D the Honorable Julien Xavier Neals, U.S.D.J. will hold a hearing (the “Settlement Hearing”) in the Federal Action.

CorMedix Form 8-K, filed August 7, 2026

The Actions arise from allegations that the Individual Defendants breached their fiduciary duties as officers and directors of CorMedix during the Relevant Period by making false and/or misleading statements and/or failing to disclose alleged manufacturing deficiencies that ultimately resulted in delayed approval of the DefenCath New Drug Application (“NDA”) which was first made public in March 2021, when CorMedix received a Complete Response Letter from the FDA. The Actions also allege that as a result of these disclosures and the subsequent decline in CorMedix’s share price, a securities fraud class action was filed against the Company and certain of its officers captioned, In re CorMedix Secs. Litig. , Case No. 2:21-cv-14020 (D.N.J.)

CorMedix Form 8-K, filed August 7, 2026

The creation of the role of Chief Manufacturing Officer on September 15, 2025, which role, among other things, (i) is held by someone with experience developing pharmaceutical products that received FDA approval, (ii) has primary responsibility for managing the Company’s pharmaceutical development and testing procedures and policies and assisting the Board with its oversight duties regarding the Company’s development; and (iii) will create, implement, and maintain a policy of generally accepted testing principles and standards.

CorMedix Form 8-K, filed August 7, 2026

The Individual Defendants have vigorously denied, and continue to deny vigorously, any and all allegations of wrongdoing or liability with respect to the claims and contentions asserted in the Actions.

CorMedix Form 8-K, filed August 7, 2026

Previously-Instituted Reforms: Defendants shall expressly acknowledge in the Stipulation that the below-listed corporate governance reforms instituted during the Actions confer substantial benefits to CorMedix and that the Actions were a material contributing factor in causing the Company to agree to implement these reforms: