The FDA will work closely with Telix to provide guidance to the Company on the development of TLX250-CDx for the diagnosis of “indeterminate renal masses” that have been identified on CT or MRI imaging.
The Break Through designation offers eligibility for Fast Track designation, more frequent and intensive interactions with the FDA, and the opportunity to submit a “rolling” Biological Licence Application (BLA) for their product.
Shares in Telix Pharmaceuticals (ASX:TLX) are trading 8.2 per cent higher at $1.39.