Telix Files BLA for TLX250-CDx (Zircaix®) in Kidney Cancer Imaging, Setting the Stage for a Breakthrough in Diagnosis

Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its investigational positron emission tomography (PET) imaging agent, TLX250-CDx (Zircaix™, 89Zr-DFO-girentuximab), for the imaging of clear cell renal cell carcinoma (ccRCC). This submission marks a significant milestone for Telix, as it paves the way for the commercial availability of this novel, non-invasive imaging agent for kidney cancer patients in the U.S. in 2024, subject to regulatory review and approval.