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Telix Completes Enrollment in Phase 3 BiPASS Study, Aligns with FDA on NDA Pathway

$TLXPress releaseSep 1, 2026, 6:18 PM ETRead the release

Telix completed enrollment of 350 patients in its Phase 3 BiPASS study, evaluating Illuccix and Gozellix for prostate cancer imaging prior to biopsy. The company has aligned with the FDA on an NDA pathway for BiPASS, which if approved, would support new product reimbursement and broaden patient access.

Key figures

Drug Name
Illuccix® (gallium Ga 68 gozetotide injection), Gozellix® (gallium Ga 68 gozetotide injection)
Phase Of Trial
Phase 3
Patients enrolled
350

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