Telix (ASX:TLX) granted FDA Break Through status for cancer treatment

Company News

by Rachael Jones

Telix Pharmaceuticals (ASX:TLX) reports that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy (BT) designation for Telix’s renal cancer imaging product.

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.

Rachael Jones

Finance News Network
Rachael comes to FNN after working for Fairfax Media covering international breaking news, including the global economy and politics. She joined FNN in February 2018. She has reported on Australia’s finance news for various organisations since 2000 and has also interviewed a number of key business players, including Bill Gates. Rachael has also worked across a number of countries, including the UK and the US.