Telix Gets FDA Fast Track Status for Prostate Cancer Imaging System

08:36 AM EDT, 09/30/2026 (MT Newswires) -- Telix (TLX) said Wednesday the US Food and Drug Administration granted fast track designation to its BiPASS prostate cancer imaging program. BiPASS evaluates the use of gallium-68 imaging alongside MRI scans to detect prostate cancer before conducting a biopsy, the company said. Patient enrollment recently concluded for a phase 3 study testing the company's Illuccix and Gozellix imaging agents with MRI for pre-biopsy diagnosis, following earlier trials that showed the combination improved cancer detection and reduced biopsies by almost 50%, Telix said. Shares of the company were down 2.5% in Wednesday premarket activity.