CorMedix Inc. (CRMD) · Oct 19, 2026 · Other events

CorMedix FDA accepts REZZAYO sNDA, Priority Review set for 2027

Priority Review granted — PDUFA target action date in Q1 2027

CorMedix’s FDA filing for a REZZAYO prophylaxis expansion wins Priority Review, moving the program to a Q1 2027 decision—but approval remains unproven.

CorMedix is now a hospital-focused anti-infective company building on its DefenCath business and the broader commercial portfolio acquired through Melinta, which added REZZAYO and several marketed infectious-disease products.

The regulatory path is now formally active: The FDA accepted CorMedix’s supplemental application to expand REZZAYO into fungal-disease prevention for adults undergoing allogeneic stem-cell transplant, and granted Priority Review. 〔0〕

This is execution on an expected milestone, not a fresh clinical surprise: CorMedix had already reported positive Phase III ReSPECT topline results in April, including a primary-endpoint success, and had signaled that an sNDA was coming in the second half of 2026. The new information is the FDA’s formal acceptance, the Priority Review designation, and a defined decision window.

Priority Review modestly improves the launch timeline but does not remove approval risk: A Q1 2027 FDA decision gives the company a clearer path toward a potential second REZZAYO indication, while CorMedix is targeting promotional activity in the second half of 2027 if approval arrives. 〔1〕 Acceptance for filing and Priority Review are procedural milestones; they do not establish that the label will be approved or that the requested indication will be granted as submitted.

Bottom line: The filing advances REZZAYO from successful trial to active FDA review and adds a meaningful regulatory timetable. It is mildly better than the standing expectation because of Priority Review, but the major value inflection remains the Q1 2027 approval decision.

What to watch next

FDA action on REZZAYO sNDA, Q1 2027

Original filing on SEC EDGAR

More CorMedix Inc. news

CorMedix FDA accepts REZZAYO sNDA, Priority Review set for 2027 | CRMD Stock News
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