CorMedix Therapeutics Announces Positive Topline Results from Phase III ReSPECT Trial Assessing REZZAYO® for the Prophylaxis of Invasive Fungal Diseases in Allogeneic Hematopoietic Stem Cell Transplantation Patients
Rhea-AI Summary
CorMedix (Nasdaq: CRMD) announced positive Phase III topline results from the global ReSPECT trial of REZZAYO (rezafungin) for prophylaxis of invasive fungal diseases in adult allogeneic HSCT patients. The study met its primary endpoint, showing non-inferiority for fungal‑free survival at Day 90: 60.7% for rezafungin vs 59.0% for standard antimicrobial regimen.
Results reported comparable efficacy for Candida, Aspergillus and Pneumocystis, comparable mortality, and a favorable safety profile with fewer toxicity‑related discontinuations and reduced drug‑drug interactions. Mundipharma sponsored the trial; a pre‑NDA meeting is planned with FDA, targeting an sNDA submission in 2H26.
Positive
- Primary endpoint met: non-inferiority for fungal‑free survival at Day 90 (60.7% vs 59.0%)
- Comparable efficacy vs SAR for Candida, Aspergillus, Pneumocystis and comparable mortality
- Favorable safety secondary endpoints: fewer toxicity‑related discontinuations and reduced drug‑drug interactions
- Regulatory path: pre‑NDA meeting planned and target sNDA submission in 2H26
Negative
- Absolute fungal‑free survival difference was 1.7 percentage points in favor of rezafungin
- Topline release lacks detailed statistical measures and p‑values needed to assess robustness
- Commercial rights split: Mundipharma outside the U.S. and Melinta for U.S. distribution could complicate rollout
News Market Reaction – CRMD
In the Apr 27 session, CRMD gained 5.39%, reflecting a notable positive market reaction. Argus tracked a peak move of +2.3% during that session. Our momentum scanner triggered 8 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Sep 29 | Clinical trial update | Positive | +4.9% | Completion of enrollment in Phase III ReSPECT trial for REZZAYO prophylaxis. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Prior clinical-trial news for REZZAYO was followed by a positive price reaction, indicating past market receptivity to this program’s milestones.
This announcement reports positive Phase III topline data from the ReSPECT trial for REZZAYO in allogeneic transplant patients, meeting the primary non-inferiority endpoint and showing favorable safety-related secondary outcomes. It follows the Sep 29, 2025 news that enrollment in the same Phase III ReSPECT trial was completed, which focused on prophylaxis against Candida, Aspergillus, and Pneumocystis infections. That earlier milestone produced a positive share reaction, and today’s results represent the clinical readout that trial was designed to deliver.
Key Terms
non-inferiority medical
allogeneic hematopoietic stem cell transplantation medical
invasive fungal diseases medical
pharmacokinetics/pharmacodynamics (PK/PD) medical
treatment emergent adverse events medical
supplemental New Drug Application (sNDA) regulatory
pre-NDA submission meeting regulatory
double-blind medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
– The study primary endpoint was met, showing non-inferiority vs. standard antimicrobial regimen in fungal free survival at Day 90 –
– Study showed favorable benefit for toxicity related discontinuations and drug-drug interactions –
– Rezafungin was well tolerated, with a safety profile comparable to standard antimicrobial regimens –
PARSIPPANY, N.J., April 27, 2026 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD) today 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).
The ReSPECT Phase III study, one of the largest anti-fungal multicenter, randomized, double-blind studies evaluated the efficacy and safety of once weekly rezafungin (rezafungin acetate) compared with a standard antimicrobial regimen (SAR) for the prophylaxis of invasive fungal diseases, including infections caused by Candida, Aspergillus, and Pneumocystis, in adults undergoing allogeneic HSCT. Patients undergoing allogeneic blood and marrow transplantation face prolonged periods of immunosuppression and routinely require extended antifungal prophylaxis, representing a setting where differentiated dosing, improved side effect profile, and reduced DDI is beneficial, and comparable efficacy is expected.
The ReSPECT study met its primary endpoint for FDA and EMA for fungal-free survival at Day 90 showing non-inferiority vs. SAR, with
The Phase III study topline results demonstrated comparable efficacy against invasive infections from candida, aspergillus and pneumocystis in both therapeutic arms, as well as comparable mortality. In addition, results showed a favorable profile in multiple secondary endpoints, most notably treatment emergent adverse events leading to dose reduction, interruption or withdrawal of study drug, and treatment emergent adverse events leading to study discontinuation.
“We believe this positive outcome of the Phase III ReSPECT study meaningfully strengthens REZZAYO’s long-term potential value proposition to patients and clinicians,” said Joseph Todisco, Chairman & Chief Executive Officer of CorMedix Therapeutics. “Preliminary topline results for ReSPECT demonstrate clinical efficacy in prevention against all three measured pathogens, as well as positive differentiation in certain safety related secondary endpoints, specifically drug-drug interactions and toxicity related discontinuations, which positions REZZAYO well to become an attractive alternative to the standard anti-fungal regimen, if approved by FDA for an expanded indication of prophylaxis of IFD. Our deepest gratitude goes out to the patients, their caregivers, investigators and the study staff whose dedication and participation enabled this compelling clinical outcome.”
This clinical trial has been sponsored by Mundipharma. Mundipharma has commercial rights to rezafungin outside the U.S. Mundipharma has partnered with Melinta Therapeutics, LLC, a wholly owned subsidiary of CorMedix for US distribution of rezafungin.
The companies anticipate a pre-NDA submission meeting with FDA in the coming months, followed by a target submission of a supplemental New Drug Application (sNDA) to the FDA in 2H26 based on the ReSPECT results.
About rezafungin
Rezafungin is a next generation echinocandin approved for the treatment of candidemia and invasive candidiasis in adults.1,2 Invasive candidiasis continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as
Rezafungin has been studied for the prophylaxis of invasive fungal diseases in adults undergoing allogeneic HSCT.
CorMedix estimates that the potential US market opportunity for REZZAYO in prophylaxis exceeds
REZZAYO® is a Registered Trademark of Mundipharma, used under license by Melinta Therapeutics LLC, a wholly owned subsidiary of CorMedix in the US.
About CorMedix
CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases in the United States. CorMedix is focused on selling and marketing products in institutional settings of care in the US and has field based medical and commercial infrastructure deployed in hospitals, clinics and infusion centers. Rezafungin is currently approved for the treatment of candidemia and invasive candidiasis in adults. For more information visit: www.cormedix.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements including, but not limited to statements regarding the risk that topline data from CorMedix’s and its partners’ clinical trials, including the ReSPECT study, that CorMedix announces or publishes from time to time may change as more patient data become available or may be interpreted differently if additional data is disclosed; estimates of total addressable market size; expectations regarding product utilization and sales; failure to successfully conduct future clinical trials, including due to CorMedix’s or its partners’ potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; development of unexpected safety or efficacy concerns related to CorMedix’s product candidates; expectations and timing regarding clinical trials and development and expectations of CorMedix’s product pipeline; expectations regarding implementation and perceived benefits of CorMedix’s products; continued pricing pressures and the impact of actions of governmental and private payers affecting pricing of, reimbursement for, and patient access to pharmaceuticals; and reporting obligations related thereto, the expiration of intellectual property protection for certain of the company's products and competition from generic and biosimilar products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576
References:
- REZZAYO® United States Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217417s008lbl.pdf
- Bassetti M, et al. Crit Care 2019;23(1):219.
- Cortegiani A, et al. Cochrane Database Syst Rev 2016;2016:Cd004920.
- N. Zhang et al. Global burden of hematologic malignancies and evolution patterns over the past 30 years. Blood Cancer Journal 2023, available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC10188596/pdf/41408_2023_Article_853.pdf
