Cormedix Announces FDA Acceptance for Priority Review of Supplemental NDA for Rezzayo® (Rezafungin) for Prophylaxis of Invasive Fungal Diseases

The FDA target action date is Q1 2027, with promotional efforts targeted for H2 2027 if the new indication is approved.

Rhea-AI Summary

CorMedix Therapeutics (Nasdaq: CRMD) announced FDA acceptance for Priority Review of its supplemental application for REZZAYO to prevent invasive fungal disease. Mundipharma, its global development partner, submitted the application, which has an FDA target action date in Q1 2027.

The application is supported by the Phase III ReSPECT study, which compared once-weekly rezafungin with a standard antimicrobial regimen in adults undergoing allogeneic hematopoietic stem cell transplantation, using donor blood-forming cells. CorMedix announced positive topline results in April. The company targets promotional efforts in H2 2027 if the new indication is approved. REZZAYO is already approved for certain patients with candidemia and invasive candidiasis, but is not approved for prevention of invasive fungal diseases.

3 points · 1 major

PositiveiHow this balance works

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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

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How the balance worksHow Sentiment works

0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointPhase III ReSPECT supports the application; CorMedix announced positive topline results in April.
• Moderate point. Forward-looking: it has not happened yet and may not happen.FDA acceptance and Priority Review advance REZZAYO’s supplemental application, with a Q1 2027 target action date.
• Minor point. Forward-looking: it has not happened yet and may not happen.Promotional efforts are targeted by CorMedix for H2 2027 if the new indication is approved.

Negative

• Minor pointFDA approval remains pending for the proposed prevention indication.

Key Figures

PDUFA target action date: Q1 2027 Promotional efforts target: H2 2027 Orphan drug exclusivity: Through 2035 +1 more

PDUFA target action date

Q1 2027

FDA Priority Review of the sNDA

Promotional efforts target

H2 2027

Conditional on approval for the new indication

Orphan drug exclusivity

Through 2035

REZZAYO

U.S. patent coverage

Through 2038

REZZAYO

Previous Clinical trial Reports

1 past event · Latest: Apr 27

Same Type 1 event

1. Apr 27

   Phase III results

   24h Move

   +5.4%

   Phase III ReSPECT met its primary endpoint, showing non-inferiority for fungal-free survival at Day 90.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

supplemental new drug application, priority review, pdufa, allogeneic hsct, +1 more

5 terms

supplemental new drug application regulatory

"the supplemental New Drug Application (sNDA) seeking approval"

A supplemental new drug application is a request submitted to regulatory authorities to make changes to an existing approved medication, such as adding new uses, strengths, or formulations. For investors, it signals that a pharmaceutical company is seeking approval for new product developments or expanded applications, which can impact the company's future sales, market potential, and stock value.

priority review regulatory

"the FDA has granted Priority Review"

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

pdufa regulatory

"Prescription Drug User Fee Act (PDUFA) target action date"

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.

allogeneic hsct medical

"adults undergoing allogeneic HSCT"

Allogeneic HSCT (allogeneic hematopoietic stem cell transplantation) is a medical procedure in which a patient receives blood-forming stem cells from a genetically related or unrelated donor to replace their own bone marrow and reconstitute the blood and immune system. Before the transplant the patient typically undergoes conditioning (chemotherapy, radiation, or both) to suppress their diseased marrow and make room for the donor cells; after infusion the donor cells engraft and begin producing blood cells. A key distinction is that the donor is a different person, which allows immune effects such as graft-versus-host disease (donor immune cells attacking the recipient) and graft-versus-tumor activity, both important clinical consequences of the procedure.

echinocandin medical

"a once-weekly echinocandin antifungal"

A class of antifungal drugs that block fungal cell‑wall synthesis by inhibiting the enzyme β‑(1,3)-D‑glucan synthase, which weakens the fungal cell wall and leads to cell death or growth arrest. Echinocandins are typically administered intravenously and are most active against Candida species (fungicidal) and have variable, usually fungistatic, activity against Aspergillus; they have little activity against fungi that lack β‑(1,3)-D‑glucan in their cell walls. Because they target a fungal-specific enzyme, echinocandins generally have low toxicity to human cells, but their spectrum and route of administration limit when they are used.

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PARSIPPANY, N.J., Oct. 19, 2026 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) seeking approval of REZZAYO^® (rezafungin for injection) for the prophylaxis of invasive fungal disease. The sNDA was submitted by Mundipharma, CorMedix’s global development partner, and the FDA has granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date in Q1 2027. The sNDA is supported by the Phase III ReSPECT pivotal study, for which CorMedix announced positive topline results in April. ReSPECT 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 in adults undergoing allogeneic HSCT. If REZZAYO is approved for this new indication, CorMedix is targeting to begin promotional efforts beginning in H2 2027.

“The FDA’s acceptance of this supplemental application for Priority Review is an important regulatory milestone for CorMedix, REZZAYO, and for patients who remain at risk for invasive fungal disease,” said Joseph Todisco, Chairman & Chief Executive Officer of CorMedix. “We are grateful to the patients, investigators and clinicians who participated in ReSPECT and to our partner, Mundipharma, for their contributions in reaching this point. We look forward to working closely with Mundipharma in the coming months ahead of FDA’s action date and will begin to prepare for a potential promotional launch in the second half of 2027.”

About rezafungin

REZZAYO^® (rezafungin for injection) is a once-weekly echinocandin antifungal approved by the FDA for the treatment of candidemia and invasive candidiasis in adults and pediatric patients 12 years of age or older who have limited or no alternative options for treatment. 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, mortality rates for patients with invasive candidiasis have been reported to be as high as 40%.

Rezafungin has been studied for the prophylaxis of invasive fungal diseases in adults undergoing allogeneic HSCT. REZZAYO is not approved by the FDA for the prophylaxis of invasive fungal diseases, and its safety and efficacy for that use have not been established. Rezafungin has orphan drug exclusivity through 2035 and patent coverage through 2038 in the U.S.

REZZAYO^® is a Registered Trademark of Mundipharma, used under license by Melinta Therapeutics LLC, a wholly owned subsidiary of CorMedix Inc. in the US.

INDICATIONS AND USAGE

REZZAYO^® is an echinocandin antifungal indicated in adults and pediatric patients 12 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.

Limitations of Use
REZZAYO^® has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

IMPORTANT SAFETY INFORMATION

Contraindications

REZZAYO^® is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

Warnings and Precautions

• Hypersensitivity Reactions, including Anaphylaxis: Cases of serious hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving REZZAYO^®. If these reactions occur, discontinue REZZAYO^® and administer appropriate treatment.
• Infusion-related Reactions: REZZAYO^® may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.
• Photosensitivity: REZZAYO^® may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.
• Hepatic Adverse Reactions: Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO^®. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO^® therapy.

Adverse Reactions

Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

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 care settings in the US and has field-based medical and commercial infrastructure deployed in hospitals, clinics and infusion centers. 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 (the “Exchange Act”), 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 fact, regarding management’s expectations, beliefs, goals or plans or CorMedix’s prospects are forward-looking statements. These include but are not limited to statements regarding the timing and outcome of the FDA’s review of the sNDA for REZZAYO for the prophylaxis of invasive fungal diseases, including the PDUFA target action date; the potential approval and commercial launch of REZZAYO for this indication and the timing thereof and, CorMedix’s and Mundipharma’s ability to complete the regulatory and commercialization activities necessary to support any potential approval and launch. These forward-looking statements are subject to risks and uncertainties, including the risk that the FDA may not approve the sNDA, may request additional data or analyses, may extend the review period, or may approve REZZAYO for this indication with labeling narrower than requested and the risk that topline data announced or published by CorMedix’s from its or its partners’ clinical trials, including the ReSPECT study, may change as more patient data become available or may be interpreted differently if additional data is disclosed . Acceptance for filing and Priority Review do not assure approval. 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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When is the FDA decision expected on CorMedix’s REZZAYO prevention application?

The FDA has set a Q1 2027 target action date for the supplemental application. The application, submitted by CorMedix’s development partner Mundipharma, received Priority Review.

What study supports CorMedix’s REZZAYO application for preventing invasive fungal disease?

The application is supported by the Phase III ReSPECT study. It evaluated the efficacy and safety of once-weekly rezafungin against a standard antimicrobial regimen in adults undergoing allogeneic hematopoietic stem cell transplantation. CorMedix announced positive topline results in April.

Which patients can currently receive CorMedix’s REZZAYO under its FDA-approved indication?

REZZAYO is approved to treat candidemia and invasive candidiasis in adults and pediatric patients 12 years of age or older who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety and efficacy data.