Renalytix PLC (AIM:RENX) shares dived 14% on Tuesday morning after announcing that the US regulator has delayed the review of Renalytix’s KidneyIntelX De Novo marketing authorization application.
Previous indications from the US Food and Drug Administration (FDA) were for a first-quarter completion, but this has now been pushed back to the end of the second quarter.
“Management remains optimistic and is working diligently with the FDA towards a successful outcome,” the company stated.
Shares were changing hands for 79p with a market value of £73.6mln as of 10.50am, March 21.