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Form 8-K CorMedix Inc. For: Oct 19

Mon, 19 Oct 2026 08:00:00 -0400

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FDA grants priority review to CorMedix's Rezzayo fungal prophylaxis sNDA

Mon, 19 Oct 2026 07:31:50 -0400

CorMedix Therapeutics (Nasdaq: CRMD) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental New Drug Application (sNDA) seeking approval of Rezzayo (rezafungin for injection) for the prophylaxis of invasive fungal disease, with a Priority Review designation.

The sNDA was submitted by Mundipharma, CorMedix's global development partner. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date in Q1 2027.

The application is supported by the Phase III ReSPECT pivotal study, for which CorMedix announced positive topline results in April. The trial evaluated once-weekly rezafungin compared with a standard antimicrobial regimen for prophylaxis

Cormedix Announces FDA Acceptance for Priority Review of Supplemental NDA for Rezzayo® (Rezafungin) for Prophylaxis of Invasive Fungal Diseases

Mon, 19 Oct 2026 07:30:00 -0400

PARSIPPANY, N.J., Oct. 19, 2026 (GLOBE NEWSWIRE) -- 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.

Cormedix Announces FDA Acceptance for Priority Review of Supplemental NDA for Rezzayo® (Rezafungin) for Prophylaxis of Invasive Fungal Diseases

Mon, 19 Oct 2026 07:30:00 -0400

Actinium Pharmaceuticals names Matt David as CFO

Thu, 15 Oct 2026 07:31:14 -0400

Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) appointed Matt David, M.D., as Chief Financial Officer, the company announced Oct. 15, 2026. Dr. David will oversee finance, accounting, capital markets and investor relations, and will serve as the company's principal financial officer.

Dr. David joins Actinium from CorMedix Inc. (Nasdaq: CRMD), where he most recently served as Executive Vice President and Chief Business Officer. He joined CorMedix in 2020 as Executive Vice President and Chief Financial Officer. During his time there, CorMedix received U.S. Food and Drug Administration approval of DefenCath® in 2023, launched the product commercially in 2024, and acquired a commercial

Actinium Pharmaceuticals names Matt David as CFO

Thu, 15 Oct 2026 07:31:14 -0400

Actinium Pharmaceuticals names Matt David as CFO

Thu, 15 Oct 2026 07:31:14 -0400

Actinium Pharmaceuticals Strengthens Leadership Team with Appointment of Matt David, M.D. as Chief Financial Officer