CorMedix REZZAYO gets FDA Priority Review

The FDA's target action date is in Q1 2027; CorMedix targets promotional efforts in H2 2027 if the indication is approved.

Rhea-AI Filing Summary

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.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

PDUFA target action date: Q1 2027 Targeted promotional start: H2 2027 ReSPECT study phase: Phase III +4 more

7 metrics

PDUFA target action date Q1 2027 For the sNDA seeking prophylaxis of invasive fungal disease

Targeted promotional start H2 2027 CorMedix targets promotional efforts then if REZZAYO is approved for the new indication

ReSPECT study phase Phase III Pivotal study supporting the sNDA

Minimum patient age for current indication 12 years of age or older Treatment of candidemia and invasive candidiasis

Orphan drug exclusivity Through 2035 REZZAYO in the United States

U.S. patent coverage Through 2038 REZZAYO

Reported invasive candidiasis mortality rate As high as 40% Mortality rates reported for patients with invasive candidiasis

Key Terms

supplemental New Drug Application (sNDA), Priority Review, Prescription Drug User Fee Act (PDUFA) target action date, allogeneic HSCT, +2 more

6 terms

supplemental New Drug Application (sNDA) regulatory

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

A supplemental new drug application (snda) is a formal request made to regulatory authorities to make changes to an already approved medication, such as adding new uses, adjusting dosages, or improving manufacturing processes. It’s similar to updating a product’s packaging or instructions after it has been approved for sale. For investors, an snda signals ongoing development or improvements that could impact a company’s future sales or regulatory approval prospects.

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.

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

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

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.

orphan drug exclusivity regulatory

"has orphan drug exclusivity through 2035"

A regulatory right that gives a drugmaker sole approval to market a medicine for a specific rare disease for a set number of years, during which the regulator will not approve the same medicine from competitors for that same use. For investors, this is like a temporary exclusive sales permit that can protect revenue and justify higher valuation because it reduces near‑term competition and helps the company recover development costs and capture market share.

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.

FAQ

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

What is REZZAYO being reviewed for in CRMD's application?

The sNDA seeks approval of REZZAYO for prophylaxis of invasive fungal disease. REZZAYO is not FDA-approved for this use, and its safety and efficacy for prophylaxis have not been established.

When is the FDA's target action date for CRMD's REZZAYO application?

The PDUFA target action date is in Q1 2027. The application has received Priority Review.

What study supports CRMD's REZZAYO application?

The Phase III ReSPECT pivotal study evaluated once-weekly rezafungin against a standard antimicrobial regimen for prophylaxis of invasive fungal diseases in adults undergoing allogeneic HSCT. CorMedix announced positive topline results in April.

What is REZZAYO currently approved to treat?

REZZAYO is indicated for treatment of candidemia and invasive candidiasis in adults and pediatric patients 12 years of age or older who have limited or no alternative treatment options.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 10/19/2026 - 08:00 AM EDT Accepted by SEC EDGAR 10/19/2026 - 08:00 AM EDT Learn about SEC filing dates

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 19, 2026

CORMEDIX INC.

(Exact name of registrant as specified in its charter)

Delaware		001-34673		20-5894890
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

389 Interpace Parkway, Suite 450 Parsippany, NJ		07054
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (908) 517-9500

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2, below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common stock, $0.001 par value		CRMD		Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure

On October 19, 2026, CorMedix, Inc. (the “Company” or “CorMedix”) issued a press release announcing 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. A copy of the press release is furnished as Exhibit 99.1, attached hereto. 

The information in this Item 7.01 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Forward-Looking Statements

This Current Report on Form 8-K 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 Current Report on Form 8-K. 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.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit No.		Description
99.1		Press Release dated October 19, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

1

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	CORMEDIX INC.
Date: October 19, 2026	By:	/s/ Joseph Todisco
	Name:	Joseph Todisco
	Title:	Chief Executive Officer

2 

Exhibit 99.1

CORMEDIX ANNOUNCES FDA ACCEPTANCE FOR PRIORITY REVIEW OF SUPPLEMENTAL NDA FOR REZZAYO® (REZAFUNGIN) FOR PROPHYLAXIS OF INVASIVE FUNGAL DISEASES

Parsippany, NJ – October 19, 2026 – 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.

2

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

3

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 PRESS RELEASE DATED OCTOBER 19, 2026 17.3 KB

Other Documents

• EX-101 XBRL SCHEMA FILE 2.9 KB
• EX-101 XBRL LABEL FILE 33.4 KB
• EX-101 XBRL PRESENTATION FILE 21.8 KB