BiPASS (Telix prostate imaging agent): FDA status

Under review Indication: Pre-biopsy prostate cancer imaging to spare men unnecessary biopsies.

Regulatory history

• Sep 30, 2026: Breakthrough designation. Telix received US FDA Fast Track Designation for its BiPASS pre biopsy prostate cancer imaging agent. BioSpectrum Asia
• Sep 1, 2026: Application filed. Telix completed enrollment in Phase 3 BiPASS study and aligned with FDA on NDA pathway for pre biopsy prostate imaging agent. Yahoo Finance

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