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Monday, October 19, 2026
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Seeking Alpha·United States·

Cormedix gets FDA priority review for Rezzayo label expansion

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Dulan Lokuwithana

US Food and Drug Administration (FDA)
  • CorMedix (CRMD) on Monday announced that the Food and Drug Administration granted priority review for its marketing application seeking a label expansion for its antifungal therapy Rezzayo, marketed with U.K.-headquartered Mundipharma.
  • The supplemental New Drug Application aims for U.S. approval of the once-weekly injection for the prophylaxis of invasive fungal disease based on results from a Phase 3 trial called ReSPECT, which tested it against standard antimicrobials.
  • Rezzayo is already available in the U.S. for candidemia and invasive candidiasis in patients aged 12 and older who lack other treatment options.
  • The FDA is expected to decide on the sNDA in Q1 2027, and pending a favorable outcome, the company intends to begin its promotional efforts for the new indication in H2 2027.

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