CorMedix Shares Drop 14% After Type A Meeting With FDA for DefenCath
By Chris Wack
CorMedix Inc. shares were down 14% at $4 each after the company said that the Food and Drug Administration may conduct a pre-approval inspection at its manufacturing facility as part of a New Drug Application for DefenCath.
The biopharmaceutical company said that following its Type A meeting with the FDA, it intends to resubmit its new drug application for DefenCath by the middle of May.
At the Type A meeting, the FDA informed CorMedix that it is in receipt of the close-out report for inspectional observations received from its existing contract manufacturing organization, and NDA resubmission can be done at the company's discretion.
CorMedix shares are up 4% in the past 12 months.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
April 26, 2023 10:32 ET (14:32 GMT)
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