Kim Allman

The U.S. FDA has accepted Telix’sBiologics License Application (BLA) for its investigational kidney cancer imaging agent TLX250-CDx (Zircaix®, 89Zr-DFO-girentuximab), granting a Priority Review with a PDUFA date of August 27, 2025. This acceptance brings this breakthrough product one step closer to patients and paves 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. Read more on our website here: telixpharma.com/news-views/f…

Telix today announces that it has submitted its Biologics License Application (BLA) to the U.S. FDA for TLX250-CDx (Zircaix®, 89Zr-girentuximab) kidney cancer imaging. TLX250-CDx is an investigational PET drug product for the non-invasive diagnosis and characterisation of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. If approved, TLX250-CDx will be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the U.S., further building on Telix’s successful urology imaging franchise. Read more on our website here: telixpharma.com/news-views/t… TLX250-CDx has not received a marketing authorisation in any jurisdiction.

Today marked an important milestone for Telix as we commenced trading on the @Nasdaq under the ticker “TLX”. We reaffirm our founding commitment to building a world-class global business, that delivers on the promise of precision medicine through targeted radiation, helping people with cancer and rare diseases live longer, better quality lives. Listing on Nasdaq is key towards achieving these goals, and an appropriate step given our growth trajectory, leadership position in radiopharmaceuticals and expanding footprint in North America. We would like to thank the many who have helped us reach this point. Read more on our website here: bit.ly/4fNWEdY This does not constitute an offer to sell or the solicitation of an offer to buy any securities of Telix.