Telix Completes Enrollment in Phase 3 BiPASS Study for Prostate Cancer Imaging, Aligns with FDA on NDA Pathway

Telix Pharmaceuticals has announced the completion of patient enrollment in its Phase 3 BiPASS™ study, which evaluates the diagnostic performance of 68Ga-PSMA-11 PET combined with MRI for prostate cancer detection prior to biopsy. The company has also engaged positively with the FDA on a New Drug Application (NDA) pathway in the U.S., aiming to broaden access to 68Ga-PSMA-PET imaging for a larger patient population.