FDA Grants Priority Review to CorMedix sNDA for Rezzayo Fungal Prophylaxis

Key Facts

1The FDA accepted a supplemental New Drug Application (sNDA) for REZZAYO for the prophylaxis of invasive fungal diseases.

2The FDA granted Priority Review for the sNDA with a PDUFA target action date set for Q1 2027.

The U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for REZZAYO for the prophylaxis of invasive fungal diseases. GlobeNewswire reported that the FDA granted Priority Review for the application, establishing a PDUFA target action date in the first quarter of 2027. The submission follows positive topline results from the Phase III ReSPECT pivotal study, which evaluated the drug's efficacy in patients undergoing allogeneic hematopoietic stem cell transplantation.

CRMD closed at $7.26 on October 16, 2026, after reaching a session high of $7.47 and a low of $7.24. The company aims to expand the clinical indications for REZZAYO, potentially strengthening its position in the biotech sector if the new use is approved. The priority review status accelerates the regulatory timeline for this potential expansion.