MELBOURNE, Australia and INDIANAPOLIS, September 2, 2026
Telix Pharmaceuticals Limited has completed enrollment of 350 patients in its Phase 3 BiPASS™ study, marking a key development milestone for the company’s prostate cancer imaging program using 68Ga-PSMA-PET. Telix has also reached alignment with the U.S. Food and Drug Administration (FDA) on a potential New Drug Application (NDA) pathway for the BiPASS program. The regulatory pathway, if successfully completed, could support a new reimbursement framework and expand access to PSMA-PET imaging to a substantially broader population of men undergoing evaluation for suspected prostate cancer. The study is evaluating Telix’s commercial PSMA-PET imaging agents Illuccix® and Gozellix® in combination with MRI before prostate biopsy.
Telix Completes Phase 3 BiPASS Patient Enrollment
The completion of enrollment in BiPASS, or Biopsy of the Prostate Avoidance Stratification Study, represents an important step in Telix’s effort to establish a new role for PSMA-PET imaging in the pre-biopsy setting. The prospective, open-label Phase 3 study enrolled 350 patients across the United States and Australia and is designed to assess the diagnostic performance of combining MRI with PSMA-PET/CT using Telix’s 68Ga-PSMA-PET agents. The study is focused on whether this combined imaging approach can improve identification of clinically significant prostate cancer, help target biopsies more effectively and potentially reduce unnecessary biopsy procedures. Unlike the current applications of PSMA-PET, which primarily focus on staging and detecting recurrent disease, BiPASS is investigating its potential earlier in the prostate cancer diagnostic pathway.
FDA Alignment Supports Potential NDA and Reimbursement Pathway
A major component of Telix’s update is its positive engagement with the FDA regarding an NDA pathway for the BiPASS program. If supported by successful clinical data and regulatory review, the pathway could enable 68Ga-PSMA-PET imaging to reach a significantly larger patient population and potentially establish a new reimbursement opportunity in the United States. This regulatory development is particularly relevant to Telix’s commercial strategy because the company already has an established prostate cancer imaging franchise through Illuccix and Gozellix. The BiPASS program seeks to extend the clinical utility of these imaging agents into the initial diagnostic assessment of men with suspected prostate cancer, potentially positioning molecular imaging as an important component of decision-making before biopsy. The company expects the BiPASS results, together with evidence from earlier PRIMARY and PRIMARY2 studies, to support regulatory discussions and the potential expansion of PSMA-PET use…
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BiPASS Targets Earlier and More Precise Prostate Cancer Diagnosis
The clinical rationale behind BiPASS is centered on improving the diagnostic pathway for prostate cancer by combining the functional information from PSMA-PET with the detailed anatomical information provided by MRI. Telix highlighted that more than three million prostate biopsies are performed globally each year, with a substantial proportion producing negative results. By improving identification of men who are more likely to have clinically significant disease, the imaging strategy under investigation could potentially help reduce unnecessary invasive procedures while improving biopsy targeting for patients who require tissue confirmation. Earlier studies cited by Telix have indicated that combining PSMA-PET with MRI may improve detection and reduce unnecessary biopsies. Completion of enrollment and FDA alignment now move BiPASS into an important phase of its development, with the ultimate impact dependent on whether the Phase 3 study achieves its objectives and supports regulatory approval. If successful, Telix believes the program could broaden the role of precision imaging in prostate cancer diagnosis and expand patient access to gallium-based PSMA-PET imaging.
Source :Telix Pharmaceuticals,,,press relese
