CorMedix (CRMD) has upcoming FDA regulatory milestones for REZZAYO. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by CorMedix (CRMD).
Over the past two years, CorMedix has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
REZZAYO and DefenCath. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
REZZAYO FDA Regulatory Timeline and Events
REZZAYO is a drug developed by CorMedix for the following indication: in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- REZZAYO
- Announced Date:
- April 27, 2026
- Indication:
- in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT).
Announcement
CorMedix Therapeutics announced positive Phase III topline results from the global ReSPECT clinical trial evaluating REZZAYO® (rezafungin for injection) for prophylaxis of invasive fungal diseases (IFDs) in adult patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
AI Summary
CorMedix Therapeutics announced positive Phase III topline results from the global ReSPECT trial of REZZAYO (rezafungin for injection) for preventing invasive fungal diseases in adults undergoing allogeneic hematopoietic stem cell transplantation. The study met its primary endpoint, showing non-inferiority to standard antimicrobial regimens for fungal-free survival at Day 90. The trial also showed a favorable effect on toxicity-related treatment discontinuations and on drug–drug interactions. Rezafungin was well tolerated, with a safety profile comparable to standard regimens.
The ReSPECT trial was sponsored by Mundipharma, which holds commercial rights outside the U.S. and has partnered with Melinta Therapeutics (a CorMedix subsidiary) for U.S. distribution. The companies plan a pre-NDA meeting with the FDA and aim to submit a supplemental NDA in the second half of 2026 based on these results. CorMedix estimates the U.S. prophylaxis market opportunity may exceed $2 billion; rezafungin has orphan exclusivity through 2035 and U.S. patent coverage through 2038.
Read Announcement- Drug:
- REZZAYO
- Announced Date:
- September 29, 2025
- Target Action Date:
- Q2 2026
- Estimated Target Date Range:
- April 1, 2026 - June 30, 2026
- Indication:
- in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT).
Announcement
CorMedix Inc. announced that Topline Results from ReSPECT Study Expected in 2Q 2026
AI Summary
CorMedix Inc. has finished enrolling patients in its global Phase III ReSPECT study, which is testing REZZAYO® (rezafungin) as a once-weekly prevention for invasive fungal infections in adults receiving allogeneic blood and marrow transplants. The randomized, double-blind trial compares a loading dose of rezafungin followed by weekly doses against a standard antifungal regimen. The main goal is to measure fungal-free survival at day 90, with secondary measures including infection rates, treatment tolerability and adjusted mortality. Topline results from the ReSPECT study are expected in the second quarter of 2026.
REZZAYO is already approved in the U.S. for treating candidemia and invasive candidiasis in adults. CorMedix believes a positive prophylaxis indication could meet a critical unmet need and expand its market opportunity. The company looks forward to sharing the study’s key findings in mid-2026 as it advances toward potential FDA approval.
Read Announcement- Drug:
- REZZAYO
- Announced Date:
- September 29, 2025
- Indication:
- in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT).
Announcement
CorMedix Inc.announced completion of enrollment for the ongoing, global Phase III ReSPECT trial evaluating the efficacy of REZZAYO® (rezafungin), a single-agent echinocandin in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT).
AI Summary
CorMedix Inc. announced completion of enrollment in its ongoing global Phase III ReSPECT trial evaluating the antifungal drug REZZAYO® (rezafungin) for adults undergoing allogeneic blood and marrow transplantation. REZZAYO is a once-weekly echinocandin being tested to prevent Candida, Aspergillus, and Pneumocystis infections. The study is randomized, double-blind, and compares REZZAYO with a standard antifungal regimen.
Participants receive a 400 mg loading dose in week one, followed by 200 mg weekly for 13 weeks alongside matching placebos. The primary endpoint is fungal-free survival at day 90. Secondary objectives include the incidence of invasive fungal disease, treatment discontinuation due to toxicity, and mortality adjusted for patients’ other health conditions.
Sponsored by Mundipharma in the UK, the trial’s US distribution rights are licensed through CorMedix’s collaboration with Melinta Therapeutics. CEO Joseph Todisco said completing enrollment is a key step toward seeking FDA approval for REZZAYO’s prophylaxis indication. Topline results are expected in the second quarter of 2026.
Read Announcement
DefenCath FDA Regulatory Events
DefenCath is a drug developed by CorMedix for the following indication: for the prevention of catheter-related bloodstream infections (“CRBSIs”) in patients with end-stage renal disease receiving hemodialysis through a central venous catheter.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DefenCath
- Announced Date:
- December 18, 2025
- Indication:
- for the prevention of catheter-related bloodstream infections (“CRBSIs”) in patients with end-stage renal disease receiving hemodialysis through a central venous catheter.
Announcement
CorMedix Therapeutics announced interim results for the Company's ongoing real-world evidence study being conducted in conjunction with U.S. Renal Care's (USRC) use of DefenCath in adult hemodialysis patients with central venous catheters.
AI Summary
CorMedix reported interim results from a real‑world evidence study with U.S. Renal Care (USRC) on DefenCath use in adult hemodialysis patients with central venous catheters. The study began after the July 2024 outpatient launch and is tracking catheter‑related bloodstream infections (CRBSI) and hospitalizations for two years. More than 3,000 patients per month now receive DefenCath at USRC sites, and the company analyzed data from roughly 7,000 patients who received at least one dose in Year 1 through September 30, 2025.
Compared with historical controls, interim results showed a 72% reduction in CRBSI and a 70% reduction in hospitalizations linked to those infections. CorMedix said this represents a meaningful risk reduction for vulnerable patients and could cut healthcare costs; CRBSI hospitalizations are costly, often estimated at about $63,000 each and up to $110,000 when including other sequelae.
CorMedix plans to use these data with customers and payers to expand access and reimbursement. Secondary outcomes—missed treatments, antibiotic use, and tPA use—are being evaluated and may be reported later as the two‑year study continues.
Read Announcement- Drug:
- DefenCath
- Announced Date:
- June 6, 2024
- Indication:
- for the prevention of catheter-related bloodstream infections (“CRBSIs”) in patients with end-stage renal disease receiving hemodialysis through a central venous catheter.
Announcement
CorMedix Inc. announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® qualifies for pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). Pass-through status provides for separate payment under Medicare Part B for the utilization of DefenCath in the out-patient ambulatory setting for a period of at least two years, and up to a maximum of three years.
AI Summary
CorMedix Inc. announced that the Center for Medicare & Medicaid Services (CMS) has given DefenCath® pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). This decision means that hospitals will receive separate Medicare Part B payments for using DefenCath in outpatient settings. The pass-through status is granted for a period of at least two years and up to three years, helping ensure that providers are adequately reimbursed when performing procedures like HD-CVC placements in less-invasive, ambulatory settings.
This development is important as it supports a shift toward outpatient treatments for hemodialysis patients, who are at risk of catheter-related bloodstream infections. By securing distinct payment, the move aims to enhance patient care during the critical initial period following catheter placement, encouraging the broader use of DefenCath to reduce potentially life-threatening infections.
Read Announcement
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