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CorMedix Inc.

For the period ended Oct 19, 2026. Filed Oct 19, 2026.

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About this filing

A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.

Oct 19, 2026 · Filed Oct 19, 2026

CRMD$5.32+1.7%Stored close · as of Nov 6, 2026
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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.

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