CorMedix宣布FDA受理REZZAYO预防侵袭性真菌病sNDA并授予优先审评，PDUFA目标日为2027年一季度

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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)
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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
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EX-99.1
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ea030895701ex99-1.htm
PRESS RELEASE DATED OCTOBER 19, 2026
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.
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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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