Form 8-K

8-K — CorMedix Inc.

Accession: 0001213900-26-110477

Filed: 2026-10-19

Period: 2026-10-19

CIK: 0001410098

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

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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)

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

EX-99.1 — PRESS RELEASE DATED OCTOBER 19, 2026

EX-99.1

Filename: ea030895701ex99-1.htm · Sequence: 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.

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

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