Benzinga | Sep 7, 2021 08:49AM EDT

CorMedix Says Was Informed By Contract Manufacturer That There Are Issues Unrelated To DefenCath Manufacturing Activities; Timeline For Co. and CMO To Address Deficiencies That Are Required For Resubmission Of DefenCath NDA Is Uncertain

CorMedix Inc. (NASDAQ:CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today provided an update with respect to its resubmission timeline for the DefenCath New Drug Application ("NDA"). CorMedix has encountered delays at its third-party contract manufacturer ("CMO"). The Company was informed by the CMO that there are issues that are unrelated to DefenCath manufacturing activities. The timeline for CorMedix and the CMO to address deficiencies at the facility that are required for resubmission of the DefenCath NDA is uncertain at this time. We will provide an update when more information becomes available.

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