Telix Pharmaceuticals received FDA Fast Track designation for its BiPASS program, which evaluates 68Ga-PSMA-PET imaging combined with MRI to detect prostate cancer prior to biopsy. This regulatory milestone facilitates more frequent engagement with the FDA and may enable expedited review of a planned New Drug Application (NDA). The company recently completed enrollment in the Phase 3 BiPASS study using its proprietary agents Illuccix and Gozellix, aiming to reduce unnecessary invasive procedures by improving diagnostic confidence. Telix Pharmaceuticals is a commercial-stage global radiopharmaceutical company advancing targeted theranostics for cancer diagnosis and treatment.
