Telix Pharmaceuticals has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its new PET agent, TLX250-CDx.
TLX250-CDx (Zircaix) characterizes renal masses as clear cell renal cell carcinoma, the company said. It initiated the BLA submission in December 2023, basing it on its phase III ZIRCON study, which showed the agent to have a sensitivity of 86%, a specificity of 87%, and a positive predictive value (PPV) of 93% for clear cell renal cell carcinoma.
![A 53-year-old patient (patient number four) with a recurrent pituitary adenoma with extension of a cystic component of disease to the medial temporal lobe apparent on MRI (contoured in blue), and extension of disease to the left sphenoid bone and orbital apex apparent on [68Ga]Ga-DOTA-TATE (contoured in yellow).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/pituitary-tumor.QGsEnyB4bU.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
