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BCS

Current Report · Items 7.01, 9.01 · 8-K

CorMedix Inc.

CRMDNASDAQEQUITYCurrent

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.…

Filed Apr 27, 2026Accepted Apr 27, 2026, 8:05 AM EDTCIK 1410098Accession 0001213900-26-047748
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Company context

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.

Current securities

Historical securities (1)

Recent company filings

  1. Results of Operations and Financial Condition · Regulation FD DisclosureNov 2, 2026
  2. Regulation FD DisclosureOct 19, 2026
  3. 10-Q filingAug 13, 2026
  4. Results of Operations and Financial ConditionAug 13, 2026
  5. Other EventsAug 7, 2026

Registered securities in this filing

CORMEDIX INC. · 8-K · Filed 2026-04-27

As filed in this accession. Current/historical status below comes from the governed listing record; the cover itself remains exact to this filing.

Common stock, $0.001 par value

Symbol
CRMD
Exchange
NASDAQ
Classification
COMMON
Status
Current
Filing context

Context: AsOf2026-04-27

Dimensions: Not supplied

Accession 000121390026047748 · 1 registered-security cover member

Read the exact SEC filing ↗

Disclosure sections

Items 7.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

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…

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