CorMedix Inc (CRMD)

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CorMedix Gets FDA Rolling Review of NDA for Neutrolin >CRMD

CorMedix Inc. (CRMD) said Monday the U.S. Food and Drug Administration has granted a request for a rolling review of the new drug application for Neutrolin for the prevention of catheter-related blood stream infections in hemodialysis patients.
The biopharmaceutical company said Neutrolin has received fast track designation from FDA and the company confirmed with the FDA in a pre-NDA meeting that it was eligible to request a rolling review.
CorMedix said it remains on schedule for a potential NDA approval during the second half of 2020.
CorMedix shares rose 5% to $6.66 in premarket trading.