CorMedix Inc. filings document the regulatory record of a Nasdaq-listed biopharmaceutical company commercializing DefenCath and a broader portfolio of institutional-care specialty pharmaceuticals. Form 8-K reports cover operating results, financial condition, corporate presentations, material-event disclosures, clinical or regulatory updates and business developments following the completed Melinta Therapeutics acquisition.
Proxy statements describe shareholder voting matters, board and governance practices, equity incentive plan proposals, certificate of incorporation matters and preferred-stock voting provisions. Acquisition-related amendments include financial statements of the acquired business and pro forma financial information, while the company’s securities disclosures identify CRMD common stock listed on the Nasdaq Global Market.
CorMedix Inc. (CRMD) said the FDA accepted for filing and granted Priority Review to a supplemental New Drug Application (sNDA) seeking REZZAYO (rezafungin for injection) for prophylaxis of invasive fungal disease. Mundipharma, CorMedix’s global development partner, submitted the application; the PDUFA target action date is in Q1 2027.
The application is supported by the Phase III ReSPECT pivotal study, which evaluated once-weekly rezafungin against a standard antimicrobial regimen in adults undergoing allogeneic HSCT; CorMedix announced positive topline results in April. REZZAYO is not FDA-approved for prophylaxis, and its safety and efficacy for that use have not been established. If approved, CorMedix targets promotional efforts beginning in H2 2027. REZZAYO is currently indicated for treatment of candidemia and invasive candidiasis in adults and pediatric patients 12 years of age or older with limited or no alternative treatment options.
CorMedix Inc. (CRMD) director Janet Dillione reported the settlement of 48,909 phantom stock units, each economically equivalent to one share of common stock. On September 18, 2026, these phantom units were converted into 48,909 shares of common stock, leaving no phantom stock outstanding and resulting in 117,835 common shares held directly after the transaction. The company states this settlement occurred in connection with the termination of the CorMedix Inc. Deferred Compensation Plan for Directors.
CorMedix Inc. (CRMD) reported that Susan Blum, Chief Financial Officer, had 8,424 shares of Common Stock disposed of on 2026-08-29 in a transaction coded "F," described as payment of exercise price or tax liability by delivering or withholding securities. Following this transaction, Blum directly owned 124,315 Common Stock shares.
CorMedix Inc. (CRMD) reported that officer Elizabeth Hurlburt, Chief Operating Officer, had 8,076 shares of common stock disposed of on 2026-08-29 in a transaction coded F, described as a payment of exercise price or tax liability by delivering or withholding securities. Following this withholding transaction, she directly holds 270,463 shares of CorMedix common stock.
CorMedix Inc. (CRMD) reported that Chief Legal Officer Beth Zelnick Kaufman had 8,424 shares of common stock disposed of on 2026-08-29 in a transaction coded "F," representing payment of exercise price or tax liability by delivering or withholding securities. Following this withholding transaction, she directly holds 260,684 shares of CorMedix common stock.
CorMedix Inc. reported strong growth for the three and six months ended June 30, 2026, driven by DefenCath and the acquired Melinta infectious-disease portfolio. Total revenue and grant income reached $229.4 million for six months, up 191% year over year, with six‑month net income of $64.6 million, up 60%.
DefenCath generated six‑month product sales of $163.6 million, while Melinta products contributed $52.6 million. Grant income from the BARDA partnership was $5.1 million and contract revenue $8.0 million. Cash and cash equivalents were $256.7 million and total assets $904.1 million, partially funded by $150 million of 4.00% Convertible Senior Notes due 2030.
Gross profit and operating income more than doubled, despite higher R&D, selling, and G&A expenses tied to Melinta integration and portfolio expansion. Management notes a significant decline in DefenCath reimbursement after its TDAPA transition on July 1, 2026, which is expected to reduce net pricing and second‑half 2026 net sales.
CorMedix Inc. reported strong results for the quarter ended June 30, 2026, with consolidated revenue of $101.9 million, up from $39.7 million a year earlier. DefenCath generated $66.1 million of net sales, while the acquired Melinta portfolio contributed $35.8 million.
Net income was $26.0 million, or $0.33 basic and $0.29 diluted EPS, compared with $19.8 million in the prior-year quarter. Adjusted EBITDA rose to $58.7 million from $22.4 million. Operating expenses increased to $34.2 million, driven mainly by the full-quarter impact of the Melinta acquisition and higher R&D, selling, and G&A costs, partially offset by a $4.2 million insurance reimbursement credit.
Cash and cash equivalents were $256.7 million at June 30, 2026, and net cash from operating activities for the first half of 2026 was $128.6 million. The company maintains full-year 2026 consolidated revenue guidance of $325–$345 million and raises full-year adjusted EBITDA guidance to $125–$140 million, supported by a new multi-year DefenCath supply agreement covering all top five U.S. dialysis providers and anticipated near-term submission of an sNDA for REZZAYO prophylaxis.
CorMedix Inc. reported that the U.S. District Court for the District of New Jersey has granted preliminary approval of a proposed settlement resolving consolidated stockholder derivative suits and a related New Jersey state derivative action. A final settlement hearing is scheduled for September 23, 2026, and the outcome will bind stockholders who held CorMedix common stock on January 19, 2026, if the settlement receives final approval. The actions allege fiduciary-duty breaches related to disclosures around FDA review of DefenCath; the defendants continue to deny wrongdoing.
The settlement is non-monetary for stockholders and instead requires CorMedix to adopt and maintain for at least 3.5 years a package of corporate governance reforms. These include a new management-level Disclosure Committee overseeing SEC filings and earnings releases, enhanced Nominating and Governance Committee oversight of legal and regulatory compliance, expanded executive and director training, and a strengthened whistleblower “Speak Up Program.” The company also highlights previously implemented changes such as appointing a Chief Manufacturing Officer and separating legal, regulatory and compliance roles. CorMedix’s board, including independent directors, determined that the litigation was a material factor in adopting these measures and that the reforms will benefit the company.
Plaintiffs’ counsel intend to seek up to $3,900,000.00 in attorneys’ fees and expenses, plus potential service awards of up to $5,000 per plaintiff, to be paid by CorMedix if approved; defendants reserve the right to oppose the fee request. The notice explains how current CorMedix stockholders can object or appear at the settlement hearing, with written objections due in advance of the court date.
CorMedix Inc. reported a change in its executive leadership structure. The Board appointed current Chief Operating Officer Elizabeth Hurlburt to a newly created role of Chief Operating and Commercial Officer, giving her oversight of all commercial functions along with medical affairs, regulatory and clinical. She will continue to report to Chairman and CEO Joseph Todisco. As part of this restructuring, Michael Seckler has left the company.
CorMedix Inc. changed its independent registered public accounting firm, appointing Ernst & Young LLP (EY) as auditor for the fiscal year ending December 31, 2026. The Audit Committee dismissed CBIZ CPAs P.C. on June 25, 2026. CBIZ’s report on the 2025 financial statements contained no adverse opinion or qualification. The only reportable event during CBIZ’s tenure was a previously disclosed material weakness in internal control over financial reporting related to timely review of significant, non-routine transactions, first reported in the 2025 Form 10-K filed March 5, 2026. CBIZ has been authorized to respond fully to EY about this matter and has provided a letter to the SEC agreeing or commenting on the company’s statements.