CorMedix (NASDAQ:CRMD) used its 2026 Analyst and Investor Day to outline its shift from a single-product renal-focused company to what management described as a diversified, cash-flow-generating specialty pharmaceutical business following its acquisition of Melinta Therapeutics. Executives and external clinical experts discussed the company’s commercial portfolio, financial outlook, and pipeline priorities, with a particular focus on Rezzayo (rezafungin) and DefenCath’s planned expansion into the total parenteral nutrition (TPN) setting.
Management highlights: record 2025, transitional 2026, and synergy execution
Chairman and CEO Joe Todisco said 2025 was a record year for CorMedix, driven by DefenCath sales in hemodialysis during the TDAPA reimbursement period. He reported the company achieved “just under $260 million in net sales” and generated strong cash flow. Todisco said CorMedix used that performance to acquire Melinta Therapeutics, which he said added about $140 million of revenue on a pro forma basis and expanded the company into a multi-product specialty pharmaceutical platform.
On CorMedix’s balance sheet and valuation, Todisco said the company had approximately zero net debt, with about $150 million in cash and $150 million in debt. He reiterated guidance for 2026 EBITDA of $100 million to $125 million and noted the company’s market capitalization was roughly five times that EBITDA range.
Todisco also said that, after announcing and closing the Melinta acquisition in August, the company achieved “over $35 million in operating synergies” in less than four months. He highlighted a board-authorized share repurchase program of up to $75 million, saying the company had begun repurchases and expected to be active throughout the year.
Rezzayo in treatment: once-weekly dosing and hospital-to-outpatient potential
Chief Operating Officer Liz Hurlburt presented Rezzayo (rezafungin), describing it as a next-generation echinocandin antifungal approved to treat candidemia and invasive candidiasis. Hurlburt said rezafungin offers once-weekly dosing with long-acting pharmacokinetics and “front-loaded” plasma concentrations, contrasting it with daily dosing used for first-generation echinocandins.
Hurlburt cited STRIVE and ReSTORE as the NDA-enabling studies and said a favorable safety profile was consistently demonstrated. She said rezafungin has shown no hepatotoxicity or clinically relevant drug-drug interactions, distinguishing it from azoles.
She also emphasized potential operational advantages, including eliminating the need for a PICC line and supporting earlier discharge. CorMedix sees additional growth in outpatient infusion centers, where Hurlburt said reimbursement can be more favorable and logistical challenges are reduced. She estimated the treatment-related opportunity—incorporating additional patient groups such as intra-abdominal candidiasis and long-course deep-seated infections—at $250 million to $350 million in total addressable market.
In a clinician panel, experts repeatedly underscored challenges with diagnostics, delays from culture-based testing, and the clinical burden of drug-drug interactions and toxicity in complex patient populations such as transplant, oncology, and critically ill patients. Panelists also pointed to rising azole resistance, including concerns around Candida auris, and discussed the importance of simplifying care transitions and reducing reliance on indwelling central lines where possible.
Rezzayo in prophylaxis: RESPECT Phase 3 readout expected in Q2
Senior Vice President of Market Access Pete Sullivan focused on the prophylaxis opportunity in profoundly immunocompromised patients, including those undergoing allogeneic blood and marrow transplant and patients with hematologic malignancies. He said azoles remain standard of care in many settings, but their use is limited by hepatotoxicity and drug-drug interactions.
Sullivan described RESPECT, a global Phase 3 randomized, double-blind trial sponsored by CorMedix’s global development partner Mundipharma, comparing once-weekly rezafungin to standard antimicrobial regimens for preventing invasive fungal disease in adult allogeneic blood and marrow transplant patients. Sullivan said enrollment was completed in late 2025 and top-line results are expected later in Q2 of this year. In addition to primary efficacy, he noted the trial evaluates discontinuation due to toxicity and intolerance.
Sullivan estimated the prophylaxis market opportunity at “over $2 billion,” while acknowledging that the final opportunity would be influenced by Phase 3 data and the eventual FDA label. In discussion, panelists described practical constraints with current prophylaxis, including the need to adjust immunosuppressants like tacrolimus when starting azoles, challenges distinguishing transplant-related liver complications from azole hepatotoxicity, pill burden, patient adherence issues, and insurance copays for oral agents. They also discussed the need for better options covering Pneumocystis jirovecii pneumonia (PJP) and the growing role of CAR-T patients as another high-risk population needing prophylaxis.
DefenCath and TPN: Phase 3 Nutriguard and a catheter infection prevention gap
Executive Director of Clinical Portfolio Management Jared Crandon described CorMedix’s plan to expand DefenCath into the TPN setting, where central venous catheters are used nearly universally. He said CLABSIs in TPN patients can be caused by gram-positive, gram-negative, and fungal pathogens and are associated with significant morbidity and mortality, particularly for fungal organisms. Crandon estimated roughly 26% of TPN patients develop CLABSI in a given year.
Crandon said guidelines suggest preventive lock solutions, but there is currently no FDA-approved antimicrobial catheter lock solution for the TPN population. He described DefenCath as a combination of heparin and taurolidine, calling taurolidine a non-antibiotic antimicrobial with broad-spectrum activity and “no known resistance.”
Crandon estimated approximately 40,000 U.S. patients receive TPN each year, representing about 4.7 million infusions, and sized the addressable market at $500 million to $750 million. He said CorMedix expects DefenCath in this population to be covered as a separately billable Part B drug and reported that payer discussions suggested a willingness to cover the product, based on the costs of preventing infections, hospitalizations, and mortality.
To support the indication, Crandon said the company is enrolling Nutriguard, a Phase 3 study comparing DefenCath versus heparin for reducing CLABSI over 12 months in TPN patients. He said the target enrollment is 90 subjects and the trial was about one-quarter enrolled. In Q&A, the company described Nutriguard as an adaptive design, with a review after 14 infections and the potential to increase enrollment up to 200 patients depending on observed infection rates.
Clinicians on the TPN panel described the patient journey of suspected CLABSI as disruptive and frequently leading to hospitalization, antibiotic exposure, and sometimes catheter removal and replacement. They discussed the role of hyperglycemia and lipid delivery in infection risk and emphasized that preventive options beyond line-care bundles are limited in routine practice, with ethanol locks described as difficult to use due to coverage and catheter-related concerns.
Business development: tuck-in focus, plus Talphera investment
Looking beyond the three focus areas, Todisco highlighted a strategic investment in Talphera, describing it as a “toehold” in a complementary acute care asset with a near-term data readout potentially later this year. He said CorMedix’s business development focus has shifted from seeking another transformational deal to pursuing more synergistic “tuck-in” assets aligned with existing field deployments, while not fully closing the door on larger opportunities.
About CorMedix (NASDAQ:CRMD)
CorMedix Inc is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to reduce inflammation and prevent infection in critically and chronically ill patient populations. The company’s lead product candidate, Neutrolin, is a catheter lock solution that combines taurolidine, heparin and citrate to prevent catheter-related bloodstream infections (CRBSIs) in patients undergoing hemodialysis. Neutrolin has received market authorization in the European Union under the CE Mark and is positioned to address a significant unmet medical need for infection prevention in dialysis centers.
In addition to its lead asset, CorMedix is advancing a biochemical portfolio aimed at mitigating complications associated with peritoneal dialysis and other high-risk procedures.
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