Renalytix Shares Fall on Delay to FDA Marketing Authorization Decision on KidneyIntelX

By Anthony O. Goriainoff

London-traded shares of Renalytix PLC fell Tuesday after the company said the U.S. Food and Drug Administration would delay a De Novo marketing authorization decision on its KidneyIntelX tool to the end of the second quarter.

Shares at 0845 GMT were down 12.50 pence, or 14%, at 77.50 pence.

A De Novo request gives a marketing pathway to classify new medical devices for which certain controls provide reasonable assurances of safety and effectiveness.

The U.K.-based diagnostics group--which is listed in both London and the U.S.--said that previous indications from the FDA were for a completion of the process before the end of the first quarter.

KidneyIntelX is an artificial-intelligence-powered tool used to predict which Type 2 diabetes patients with chronic kidney disease are at risk of developing a fast decline in kidney function.

"Based on recent interactions with the FDA, while there can be no guarantees, management remains optimistic and is working diligently with the FDA towards a successful outcome," the company said.

Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com

(END) Dow Jones Newswires

March 21, 2023 05:03 ET (09:03 GMT)

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