# CorMedix Therapeutics Secures FDA Priority Review for REZZAYO Label Expansion

- URL: https://stocks.freetheai.org/news/cormedix-therapeutics-secures-fda-priority-review-for-rezzayo-label-expansion-695162
- Published: 2026-10-19T11:30:00Z
- Category: company_news; sentiment: bullish; impact: medium
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The U.S. Food and Drug Administration has accepted and granted Priority Review to a supplemental New Drug Application from CorMedix Therapeutics for its drug REZZAYO. The application seeks approval for REZZAYO to be used in the prophylaxis, or prevention, of invasive fungal disease. The agency established a Prescription Drug User Fee Act target action date in the first quarter of 2027.

Currently limited to treatment use, expanding REZZAYO's label to include preventive care could significantly broaden its addressable patient population. The regulatory filing is supported by positive topline clinical results from the Phase III ReSPECT study, reinforcing the case for potential approval.

Market participants will monitor the upcoming regulatory review leading up to the target decision date in early 2027. If approved on schedule, CorMedix Therapeutics aims to begin commercial promotion in the second half of 2027.

## Key points

- The FDA granted Priority Review for CorMedix Therapeutics' supplemental application for REZZAYO in preventing invasive fungal disease.
- A target decision date has been established for the first quarter of 2027 under the Prescription Drug User Fee Act.
- The regulatory submission is backed by positive topline data from the Phase III ReSPECT clinical trial.
- CorMedix Therapeutics plans to launch promotional commercial efforts in the second half of 2027 if approved.

## Questions and answers

### What did the FDA grant to CorMedix Therapeutics?

The FDA accepted and granted Priority Review to CorMedix Therapeutics' supplemental application for REZZAYO to prevent invasive fungal disease.

### When is the FDA target decision date for REZZAYO?

The FDA assigned a Prescription Drug User Fee Act target action date in the first quarter of 2027.

### When does CorMedix Therapeutics plan to launch REZZAYO for prevention?

If approved, CorMedix Therapeutics targets a promotional launch in the second half of 2027.