---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-26-110477"
form_type: "8-K"
ticker: "CRMD"
cik: "0001410098"
company_name: "CorMedix Inc."
filed_at: "2026-10-19T12:00:28+00:00"
generated_at: "2026-10-19T12:05:05.495618+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# CorMedix FDA accepts REZZAYO sNDA for fungal prophylaxis with Priority Review; PDUFA set for Q1 2027

## Summary
- FDA accepted for filing the sNDA, submitted by partner Mundipharma, for REZZAYO (rezafungin) prophylaxis of invasive fungal disease in adults undergoing allogeneic HSCT.
- Priority Review granted with a PDUFA target action date in Q1 2027; CorMedix targets beginning promotional efforts in H2 2027.
- sNDA supported by the Phase III ReSPECT pivotal study, for which CorMedix reported positive topline results in April 2026.
- Rezafungin holds U.S. orphan drug exclusivity through 2035 and patent coverage through 2038; REZZAYO is already approved for candidemia and invasive candidiasis.
- Company cautions acceptance and Priority Review do not assure approval; FDA could request more data, extend review, or grant narrower labeling.

## SEC filing metadata
- accession: 0001213900-26-110477
- form_type: 8-K
- ticker: CRMD
- cik: 0001410098
- company_name: CorMedix Inc.
- filed_at: 2026-10-19T12:00:28+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1410098/000121390026110477/0001213900-26-110477-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1410098/000121390026110477/ea0308957-8k_cormedix.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-26-110477
- JSON: https://secwatch.observer/filing/0001213900-26-110477.json
- Plain text: https://secwatch.observer/filing/0001213900-26-110477.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.