CorMedix Inc.: FDA accepts sNDA for prophylaxis of invasive fungal disease

What happened
CorMedix Inc. announced on Oct 19, 2026 that the U.S. Food and Drug Administration 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 company issued a press release describing the acceptance.

Key details

• The announcement was made via a press release furnished as Exhibit 99.1 to the Form 8-K dated Oct 19, 2026.
• Product named: REZZAYO (rezafungin for injection).
• Regulatory action: FDA has "accepted for filing" the sNDA that seeks approval for prophylaxis of invasive fungal disease.
• The Form 8-K reports Item 7.01 (Regulation FD disclosure).

Why it may matter
This Form 8-K reports Item 7.01, Regulation FD disclosure, and furnishes the company press release about the FDA’s acceptance for filing of the sNDA for REZZAYO for prophylaxis of invasive fungal disease. The filing does not show why the insider traded or why the company acted.