Watch for FDA decision in Q1 2027. Approval would open a new prophylaxis market for REZZAYO, potentially doubling its commercial opportunity. Monitor any AdCom meeting or FDA briefing documents ahead of the PDUFA date.
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Executive Summary
CorMedix announced FDA acceptance of its sNDA for REZZAYO (rezafungin) for prophylaxis of invasive fungal disease, with Priority Review and a PDUFA date in Q1 2027. The sNDA is supported by positive Phase III ReSPECT data. Approval would expand REZZAYO's label beyond candidemia/invasive candidiasis into a new prophylaxis indication, with a potential H2 2027 launch.
Key Facts
- FDA accepted sNDA for REZZAYO (rezafungin) for prophylaxis of invasive fungal disease
- Priority Review granted with PDUFA target action date in Q1 2027
- sNDA supported by positive Phase III ReSPECT study in allogeneic HSCT patients
- CorMedix targeting H2 2027 promotional launch if approved
- REZZAYO already approved for candidemia/invasive candidiasis; orphan drug exclusivity through 2035, patent coverage through 2038
- Mundipharma is the global development partner and submitted the sNDA
Financial Impact
Approval would expand REZZAYO's addressable market into prophylaxis for HSCT patients, a new indication with significant unmet need; no revenue or market size figures provided in the release
Risk Factors
- FDA may not approve the sNDA or may request additional data
- Priority Review acceptance does not guarantee approval
- Commercial launch dependent on approval and labeling scope
- Competition from existing antifungal prophylaxis agents
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3383327 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 19, 2026 7d ago | 8-K | $7.38 | awaiting T+20 | — | $7.81 (+5.88%) |
Oct 19, 2026 7d ago | Press Release | $7.38 | awaiting T+20 | — | $7.81 (+5.88%) |
Aug 13, 2026 10w ago | 8-K | $8.14 $7.83 | ▼ −3.87% | ▼ −2.12% | $7.81 (−4.01%) |
Aug 13, 2026 10w ago | Press Release | $8.14 $7.83 | ▼ −3.87% | ▼ −2.12% | $7.81 (−4.01%) |
Jul 1, 2026 16w ago | 8-K | $8.47 $7.19 | ▼ −15.11% | ▼ −12.93% | $7.81 (−7.75%) |
Jun 12, 2026 19w ago | Institutional Cluster | $8.74 $8.40 | ▼ −3.89% | ▼ −5.67% | $7.81 (−10.60%) |
Jun 8, 2026 20w ago | 8-K | $8.54 $8.79 | ▲ +2.93% | ▲ +1.30% | $7.81 (−8.51%) |
Jun 8, 2026 20w ago | Press Release | $8.54 $8.79 | ▲ +2.93% | ▲ +1.30% | $7.81 (−8.51%) |
May 14, 2026 23w ago | 8-K | $7.93 $8.74 | ▲ +10.21% | ▲ +11.07% | $7.81 (−1.47%) |
May 14, 2026 23w ago | Press Release | $7.93 $8.74 | ▲ +10.21% | ▲ +11.07% | $7.81 (−1.47%) |
US Market Status
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