India, Feb. 25 -- Telix Pharmaceuticals Limited (TLX,TLX.AX) announces that the U.S. Food and Drug Administration has accepted the Biologics License Application or BLA for its breakthrough investigational kidney cancer PET1 imaging agent TLX250-CDx (Zircaix2, 89Zr-DFO-girentuximab). The FDA granted a Priority Review and provided a PDUFA3 date of 27 August 2025, paving the way for a U.S. commercial launch in 2025.
If approved, TLX250-CDx will become the first commercially available imaging agent to accurately and non-invasively diagnose and characterize clear cell renal cell carcinoma (ccRCC), the most common and one of the most aggressive sub-types of kidney cancer, the company said in a statement.
TLX closed Tuesday's regular trading at ...