BiPASS (Illuccix)

Sept. 2, 2026: Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) said the Phase 3 BiPASS study of Illuccix and Gozellix completed enrollment with 350 patients in the U.S. and Australia for prostate cancer imaging in the pre-biopsy setting. BiPASS is described as the first registrational study of 68Ga-PSMA-PET in this setting and is evaluating whether PSMA-PET/CT plus MRI improves diagnostic accuracy, reduces unnecessary biopsies, or improves biopsy targeting versus current standard practice.

Telix also said it has aligned with the FDA on an NDA pathway for BiPASS in the U.S. that, if approved, could support reimbursement as a new product and broaden access to 68Ga-PSMA-PET imaging.

The company cited prior PRIMARY and PRIMARY2 studies as showing that combining 68Ga-PSMA-PET with MRI improved detection of clinically significant prostate cancer and reduced unnecessary biopsies by almost 50%. BiPASS itself has not reported efficacy results yet; the current catalyst is enrollment completion and regulatory alignment on a potential U.S. filing path.