CorMedix to resubmit DefenCath NDA by mid-May; CMS proposes NTAP up to $17,111

CorMedix Inc.

Company will resubmit NDA for DefenCath to FDA by mid-May 2023 following Type A meeting.
CMS IPPS 2024 proposed rule includes NTAP of up to $17,111 per hospital stay for DefenCath, conditional on FDA approval before July 1, 2024.
Resubmission uses existing CMO and new heparin API supplier; expects 6-month Class 2 review.
Company plans to add a 3 mL single-dose vial to commercial presentation based on market needs.
NTAP amount based on 75% of WAC price ($1,170 per 3 mL vial) and average 19.5 vials per stay.

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