Item 7.01 Regulation FD Disclosure On April 27, 2026, CorMedix, Inc. (the “Company” or “CorMedix”) issued a press release announcing an update related to the initial readout of topline data for the Phase III study (ReSPECT) assessing REZZAYO® (rezafungin for injection) for prophylaxis of invasive fungal infections. A copy of the press release is furnished as Exhibit 99.1, attached hereto.…
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. For more information visit: www.cormedix.com.
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Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure
On April 27, 2026, CorMedix, Inc. (the “Company”
or “CorMedix”) issued a press release announcing an update related to the initial readout of topline data for the Phase III
study (ReSPECT) assessing REZZAYO® (rezafungin for injection) for prophylaxis of invasive fungal infections. 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, and Section
21E of 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 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 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.
Filed exhibits (1)
EX-99.1 (by filename) ea028764001ex99-1.htm
EX-99.1
2
ea028764001ex99-1.htm
PRESS RELEASE DATED APRIL 27, 2026
Exhibit 99.1
CORMEDIX Therapeutics AnnounceS POSITIVE Topline Results from PHASE III respect TriaL assessing Rezzayo® for the PROPHYLAXIS of
invasive fungal diseases in ALLOGENEIC Haematopoietic Stem Cell Transplantation PATIENTS
- 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, NJ - April 27, 2026 - 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 standar…