---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-23-050240"
form_type: "8-K"
ticker: "CRMD"
cik: "0001410098"
company_name: "CorMedix Inc."
filed_at: "2023-06-21T23:59:59+00:00"
generated_at: "2026-06-13T19:53:24.787700+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# CorMedix announces FDA acceptance of DefenCath NDA resubmission; PDUFA date Nov 15, 2023

## Summary
- FDA accepted DefenCath NDA resubmission as a complete Class 2 response with six-month review.
- PDUFA target action date set for November 15, 2023.
- DefenCath is a catheter lock solution to reduce bloodstream infections in hemodialysis patients.
- CEO Joe Todisco highlighted preparations for potential commercial launch.

## SEC filing metadata
- accession: 0001213900-23-050240
- form_type: 8-K
- ticker: CRMD
- cik: 0001410098
- company_name: CorMedix Inc.
- filed_at: 2023-06-21T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1410098/000121390023050240/0001213900-23-050240-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1410098/000121390023050240/ea180659-8k_cormedix.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-23-050240
- JSON: https://secwatch.observer/filing/0001213900-23-050240.json
- Plain text: https://secwatch.observer/filing/0001213900-23-050240.txt

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