Telix wins FDA Fast Track for BiPASS pre-biopsy prostate cancer imaging study

• Telix received FDA Fast Track designation for BiPASS, a Phase 3 program testing 68Ga PSMA-PET with MRI before prostate biopsy.
• Enrollment in the Phase 3 study is complete; no trial results were reported in the announcement.
• Fast Track increases FDA interaction, potentially supporting an accelerated review timetable for a planned NDA submission.
• The program targets earlier diagnosis, aiming to reduce unnecessary biopsies while improving identification of clinically significant prostate cancer.
• Illuccix and Gozellix remain investigational for pre-biopsy use despite existing approvals in other prostate cancer imaging settings.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Telix Pharmaceuticals Ltd. published the original content used to generate this news brief on September 30, 2026, and is solely responsible for the information contained therein.