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Biotech Stocks Facing FDA Decision In November 2023

CorMedix
CorMedix

The FDA decision on CorMedix Inc.’s (CRMD) DefenCath, a novel, antimicrobial catheter lock solution, is due on November 15, 2023.

DefenCath is proposed for use in reducing catheter-related bloodstream infections (CRBSIs) in patients with kidney failure who are receiving chronic hemodialysis via a central venous catheter.

This is the company’s third attempt to secure FDA approval for DefenCath.

The FDA had declined to approve DefenCath in March 2021 as well as in August 2022, citing deficiencies in the contract manufacturing organization (CMO) and the supplier of the active pharmaceutical ingredient (API) heparin.

CRMD closed Friday’s trading at $3.00, down 2.60%.