Watch for the PDUFA decision in Q1 2027 and any FDA advisory committee meeting announcement, which would be a key binary catalyst. Also monitor for any pre-launch commercial infrastructure investments by CorMedix or partner Mundipharma ahead of H2 2027 target launch.
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Executive Summary
CorMedix announced that the FDA has accepted for filing and granted Priority Review to its supplemental New Drug Application (sNDA) for REZZAYO (rezafungin for injection) for prophylaxis of invasive fungal disease, with a PDUFA target action date in Q1 2027. The sNDA is supported by positive Phase III ReSPECT data, and if approved, CorMedix targets promotional launch in H2 2027. This is a significant regulatory milestone that de-risks a major label expansion for REZZAYO.
Key Facts
- FDA accepted sNDA for REZZAYO for prophylaxis of invasive fungal disease
- Priority Review granted with PDUFA target action date in Q1 2027
- sNDA supported by positive Phase III ReSPECT pivotal study
- If approved, CorMedix targets promotional launch beginning H2 2027
- REZZAYO already approved for candidemia and invasive candidiasis
- Orphan drug exclusivity through 2035 and patent coverage through 2038 in the U.S.
Financial Impact
Label expansion into prophylaxis represents a major new market opportunity for REZZAYO; no financial figures provided in filing
Risk Factors
- FDA may not approve the sNDA or may request additional data
- FDA may approve with narrower labeling than requested
- Review period could be extended
- Topline ReSPECT data could change as more patient data become available
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001213900-26-110477 |
| Document: ea030895701ex99-1.htm | 0001213900-26-110477 |
| Document: 0001213900-26-110477-index-headers.html | 0001213900-26-110477 |
| Document: 0001213900-26-110477-index.html | 0001213900-26-110477 |
| Document: 0001213900-26-110477.txt | 0001213900-26-110477 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 19, 2026 7d ago | 8-K | $7.38 | awaiting T+20 | — | $7.85 (+6.37%) |
Oct 19, 2026 7d ago | Press Release | $7.38 | awaiting T+20 | — | $7.85 (+6.37%) |
Aug 13, 2026 10w ago | 8-K | $8.14 $7.83 | ▼ −3.87% | ▼ −2.12% | $7.85 (−3.56%) |
Aug 13, 2026 10w ago | Press Release | $8.14 $7.83 | ▼ −3.87% | ▼ −2.12% | $7.85 (−3.56%) |
Jul 1, 2026 16w ago | 8-K | $8.47 $7.19 | ▼ −15.11% | ▼ −12.93% | $7.85 (−7.32%) |
Jun 12, 2026 19w ago | Institutional Cluster | $8.74 $8.40 | ▼ −3.89% | ▼ −5.67% | $7.85 (−10.18%) |
Jun 8, 2026 20w ago | 8-K | $8.54 $8.79 | ▲ +2.93% | ▲ +1.30% | $7.85 (−8.08%) |
Jun 8, 2026 20w ago | Press Release | $8.54 $8.79 | ▲ +2.93% | ▲ +1.30% | $7.85 (−8.08%) |
May 14, 2026 23w ago | 8-K | $7.93 $8.74 | ▲ +10.21% | ▲ +11.07% | $7.85 (−1.01%) |
May 14, 2026 23w ago | Press Release | $7.93 $8.74 | ▲ +10.21% | ▲ +11.07% | $7.85 (−1.01%) |
US Market Status
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