CorMedix Wins Priority Review for Rezzayo Prevention Use, With FDA Action Targeted for Early 2027

Key Facts

CorMedix Therapeutics announced that the U.S. Food and Drug Administration had accepted for filing a supplemental application for Rezzayo to prevent invasive fungal diseases and granted priority review to assess the proposed use. Mundipharma, CorMedix's global drug development partner, submitted the application as part of efforts to secure approval for preventive use. CorMedix said in its statement that the drug "has not received FDA approval for the prevention of invasive fungal diseases," the use covered by the new application. According to the FDA, priority review targets action within 6 months, compared with 10 months under standard review. The agency stresses that the designation "does not alter the scientific and medical standard for approval," nor does it change the quality of evidence required to approve a drug.

The application is based on results from the ReSPECT study, which met its primary endpoint by demonstrating non-inferiority of rezafungin, the active ingredient in Rezzayo, to the standard regimen used in the study, according to CorMedix's announcement of the results. Fungal-free survival among rezafungin recipients was 60.7% at the day 90 assessment. In the comparison group receiving the standard regimen, fungal-free survival was 59.0% over the same assessment period, according to results announced by the company. On the commercial front, CorMedix estimates the potential U.S. market opportunity for preventive use at more than $2 billion, according to its statement on the study results. The company's estimate is based on its internal analyses and assumptions about the target market for preventing invasive fungal diseases.

Rezzayo received its original U.S. approval on March 22, 2023, according to the FDA's record for the drug. Its currently approved use covers the treatment of candidemia and invasive candidiasis, according to the official prescribing information published in the DailyMed database. The prescribing information, revised in July 2026, permits its use in adults and children aged 12 years or older within the populations specified in the drug's current U.S. treatment approval. This therapeutic use is restricted to patients with limited or no available alternatives, under the indication specified in the prescribing information. For this approved use, the drug is administered by intravenous infusion once weekly, according to the administration instructions in the official prescribing information.

Commercial rights to the drug are divided between the U.S. and overseas markets, with Mundipharma holding marketing rights outside the United States, according to CorMedix's announcement of the study results. Mundipharma collaborates with Melinta to distribute the drug in the United States under the commercial arrangements CorMedix announced for Rezzayo. Melinta is a wholly owned CorMedix subsidiary and the U.S. party in the drug distribution collaboration, according to the same statement presenting the ReSPECT results. On legal protection for the drug, CorMedix says rezafungin has orphan drug exclusivity extending through 2035. The company adds that U.S. patent coverage for the drug extends through 2038, according to the protection details it provided when announcing the study results.

The regulatory progress comes as CorMedix reported consolidated revenue of $101.9 million for the second quarter of 2026, according to its financial results statement for the period. Revenue in the corresponding period of 2025 was about $39.7 million, according to the comparative figures in the company's second-quarter results statement. The acquired Melinta portfolio contributed $35.8 million to second-quarter 2026 revenue, according to CorMedix's breakdown of the portfolio's contribution to its business. At the end of the second quarter of the same year, CorMedix held $256.7 million in cash and short-term investments, according to the financial statement. That balance excludes restricted cash, under the definition the company used when disclosing its cash and short-term investments at the end of the period.

Attention now turns to the first quarter of 2027, the announced target for FDA action on the supplemental application for preventive use, according to CorMedix. When reporting its second-quarter results, the company had previously expected agency action in the first half of 2027. The latest regulatory update places the target in the first quarter, within the broader timeframe the company had announced in its previous business update. The date remains a target for regulatory action, with a possible extension of the review, while authorization for preventive use remains subject to FDA approval. On commercial preparations, CorMedix aims to begin promotional efforts for this use in the second half of 2027, subject to approval, according to its announced plan.