regulatory
confidence high
sentiment positive
materiality 0.60
CorMedix announces FDA acceptance of DefenCath NDA resubmission; PDUFA date Nov 15, 2023
CorMedix Inc.
- 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.