---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-22-046610"
form_type: "8-K"
ticker: "CRMD"
cik: "0001410098"
company_name: "CorMedix Inc."
filed_at: "2022-08-11T23:59:59+00:00"
generated_at: "2026-06-24T00:43:57.652528+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# CorMedix receives second FDA CRL for DefenCath; Q2 net loss $7.6M

## Summary
- Second CRL from FDA for DefenCath NDA due to unresolved deficiencies at CMO and heparin supplier.
- Entered agreement with Alcami as alternative manufacturer; expects to submit NDA supplement around Q1 2023.
- CMS granted conditional NTAP reimbursement, conditioned on FDA approval before July 1, 2023.
- Net loss Q2 2022: $7.6M ($0.19/share) vs $4.6M ($0.12/share) in Q2 2021; OpEx $8.3M, up 41%.
- Cash and short-term investments $64.6M at June 30, 2022; funding through at least Q3 2023.

## SEC filing metadata
- accession: 0001213900-22-046610
- form_type: 8-K
- ticker: CRMD
- cik: 0001410098
- company_name: CorMedix Inc.
- filed_at: 2022-08-11T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1410098/000121390022046610/0001213900-22-046610-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1410098/000121390022046610/ea164139-8k_cormedixinc.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-22-046610
- JSON: https://secwatch.observer/filing/0001213900-22-046610.json
- Plain text: https://secwatch.observer/filing/0001213900-22-046610.txt

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