Telix Pharmaceuticals submits NDA for new prostate cancer imaging agent

Telix Pharmaceuticals announces it has submitted a New Drug Application, NDA, to the United States Food and Drug Administration, FDA, for TLX007-CDx, a new and proprietary cold kit for the preparation of PSMA-PET imaging for prostate cancer. Subject to regulatory approval, this Kit will enable use of a PSMA imaging product with a considerably extended distribution profile compared to currently approved gallium-68 PSMA-PET imaging agents. The Kit’s properties are designed to facilitate more flexible production, including with 68Ga sourced from both newer high activity generators and cyclotrons powered by the ARTMS QUANTM Irradiation System2 and GE FASTlab3 solid and liquid target production system. The Company believes this will further expand the availability, distribution and scheduling flexibility of PSMA-PET imaging.