CRMD - CorMedix announces FDA acceptance of marketing application for lead candidate

CorMedix (NASDAQ:CRMD) is trading ~7% higher in the pre-market Monday after the development stage pharma company announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for DefenCath, an anti-infective solution. The regulators have determined that the resubmission was a complete Class 2 response with a six-month review cycle. CorMedix (CRMD) has developed DefenCath as a catheter lock solution for initial use in the reduction of catheter-related bloodstream infections (CRBSIs) in renal failure patients who are subject to chronic hemodialysis via a central venous catheter. According to the Head of Technical Operations at CorMedix (CRMD), Phoebe Mounts, the FDA has already started its review process. “FDA has begun review of the filing and we have learned from our contract manufacturer that it has been notified by FDA that an onsite inspection has been scheduled as part of the review process,” Mounts noted.

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CorMedix announces FDA acceptance of marketing application for lead candidate