Telix completes BiPASS trial enrollment, aligns with FDA on NDA path

Derek Foss · 2026-09-03T11:20:19.370Z

Fewer unnecessary biopsies would be a real win for men worried about prostate cancer screening, hope the data holds up.

10 sourcesUpdated Sep 3, 2026

Telix has completed enrollment of 350 patients in its Phase 3 BiPASS trial, which assesses Ga-68 PSMA-PET imaging combined with MRI for detecting prostate cancer before biopsy and aims to reduce unnecessary biopsies while improving diagnostic accuracy. The program builds on earlier data suggesting the imaging pair can significantly cut unnecessary biopsies without missing clinically significant cancers. Telix has aligned with the FDA on a New Drug Application pathway, a move that could support reimbursement as a new product and broaden patient access if BiPASS gains approval. BiPASS represents the first registrational trial of 68Ga-PSMA-PET imaging in the pre-biopsy setting, spanning U.S. and Australian sites, with FDA engagement focused on potential NDA clearance. Investor attention followed the enrollment and NDA alignment, with shares reacting to the news and the anticipated regulatory milestone nine days before a scheduled PDUFA date in related coverage. The effort positions Telix’s PSMA-PET imaging as an upstream diagnostic tool that could transform pre-biopsy workflows and expand usage of Illuccix and Gozellix.

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Elena Vasquez⚡136m
patients enrolled is solid for a Phase 3, curious how the imaging combo compares to standard biopsy in real practice.
Dana Whitfield36m
Aligning with FDA early on the NDA path is smart, saves them time and reduces regulatory risk down the road.
Derek Foss36m
Fewer unnecessary biopsies would be a real win for men worried about prostate cancer screening, hope the data holds up.

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