3 June 2024 - Telix today announces that it has completed the submission of a biologics license application to the US FDA for its investigational radiodiagnostic PET1 agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), for the characterisation of renal masses as clear cell renal cell carcinoma.

The rolling biologics license application submission, initiated in December 20233 with timelines pre-agreed with the FDA, was based on Telix’s successful global Phase 3 ZIRCON4 study in clear cell renal cell carcinoma.

Read Telix Pharmaceuticals press release