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Telix Completes BiPASS Enrollment, Advances FDA NDA Pathway for Prostate Imaging
8:16am on Wednesday 2nd of September, 2026 AEST
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Healthcare
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Telix Completes BiPASS Enrollment, Advances FDA NDA Pathway for Prostate Imaging
8:16am on Wednesday 2nd of September, 2026 AEST
Key Points
Phase 3 BiPASS study enrolls 350 patients in US and Australia
FDA alignment on New Drug Application pathway for Illuccix and Gozellix
BiPASS evaluates combined 68Ga-PSMA-PET and MRI to improve pre-biopsy diagnosis
Potential to reduce unnecessary prostate biopsies by nearly 50%
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Telix Pharmaceuticals (ASX:TLX)
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