Telix completes BiPASS Phase 3 enrollment and aligns with FDA on NDA pathway
Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) announced on 2 September 2026 that it has completed patient enrollment in the Phase 3 BiPASS™ study of its commercial PSMA-PET imaging agents, Illuccix® and Gozellix® (both kits for the preparation of gallium Ga68 gozetotide injection), for prostate cancer imaging in the pre-biopsy setting. The company has also aligned with the United States Food and Drug Administration (FDA) on a New Drug Application (NDA) pathway.
BiPASS is described as the first registrational study of 68Ga-PSMA-PET imaging in the pre-biopsy setting. A total of 350 patients were enrolled across the U.S. and Australia in the prospective, open-label Phase 3 trial. According to the company, if approved, the NDA pathway would support reimbursement as a new product and broaden patient access.
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Why the pre-biopsy market opportunity is significant
BiPASS is designed to evaluate whether combining magnetic resonance imaging (MRI) with PSMA-PET/CT using Telix’s proprietary 68Ga-PSMA-11 agents can improve diagnostic accuracy, reduce unnecessary biopsies, or improve biopsy targeting compared with current standard practice. The clinical problem it aims to address is substantial.
The burden of prostate biopsy is highlighted by several statistics cited in the announcement:
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More than three million prostate biopsies are performed globally each year.
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Up to 75% are found to be negative.
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Approximately one in four patients decline a physician recommendation to undergo biopsy.
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Biopsy is often stressful and painful, may lead to complications, and delivers no real diagnostic benefit for many patients.
According to Telix, successful implementation of BiPASS could broaden access to 68Ga-PSMA-PET imaging across a substantially larger patient population. This represents a potential expansion beyond the current use of the imaging agents in initial staging and secondary re-staging.
Building on the PRIMARY and PRIMARY2 foundation
BiPASS builds on the clinical foundation established by the landmark PRIMARY and PRIMARY2 studies. These studies demonstrated that combining 68Ga-PSMA-PET imaging with MRI can significantly improve the detection of clinically significant prostate cancer while reducing unnecessary biopsies by almost 50%.
If BiPASS meets its primary objectives, the data, alongside evidence from PRIMARY and PRIMARY2, have the potential to shift 68Ga-PSMA-PET beyond its current use in initial staging and secondary re-staging at disease recurrence, and establish precision imaging as a critical step in initial diagnosis.
Understanding PSMA-PET and theranostics
PSMA-PET is a precision imaging technique that targets prostate-specific membrane antigen (PSMA), a protein commonly found on prostate cancer cells, using positron emission tomography to visualise where disease is present. The BiPASS study is testing whether combining MRI with PSMA-PET/CT can improve diagnostic accuracy, reduce unnecessary biopsies, or improve biopsy targeting versus current standard practice.
Telix describes theranostics as an approach that pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease. For investors, a diagnostic used earlier in the patient journey could expand where and how often Telix’s commercial imaging agents are used.
What management is saying
Clinical investigators involved in the trial have pointed to its potential to reduce unnecessary procedures. BiPASS Investigator Professor Louise Emmett noted that the PRIMARY and PRIMARY2 studies showed 68Ga-PSMA-PET, used alongside MRI, can safely halve the number of biopsies required without missing clinically significant prostate cancer.
Dr. David N. Cade, Telix Group Chief Medical Officer
“Recruitment of BiPASS was completed rapidly, reflecting strong enthusiasm from clinicians and patients for a more accurate, non-invasive approach to diagnosis… Telix is uniquely positioned to define and lead this patient-first approach that, if approved, would represent a new clinical application with a reimbursement pathway that facilitates much broader patient access to gallium-based PSMA-PET.”
Telix’s broader franchise and pipeline
Telix is a commercial-stage global radiopharmaceutical company advancing targeted theranostics across the patient journey. Its commercial franchise is anchored by its prostate cancer imaging portfolio, complemented by a late-stage therapeutic pipeline of three investigational assets in pivotal-stage trials.
Telix’s Q2 2026 revenue results showed Precision Medicine, anchored by Illuccix and Gozellix, delivering US$202 million for the quarter, with U.S. dose volumes growing 7% as the dual-product PSMA imaging strategy continued to gain commercial traction.
| Asset | Type | Indication | Status |
|---|---|---|---|
| Illuccix® | Imaging agent | Prostate cancer | Commercially available in 22 countries incl. U.S. |
| Gozellix® | Imaging agent | Prostate cancer | FDA approved |
| TLX591-Tx (177Lu rosopatamab tetraxetan) | Therapeutic | Prostate cancer | Pivotal-stage trial |
| TLX101-Tx (131I-iodofalan) | Therapeutic | Recurrent glioblastoma | Pivotal-stage trial |
| TLX250-Tx (177Lu girentuximab tetraxetan) | Therapeutic | Kidney cancer | Pivotal-stage trial |
The pre-biopsy opportunity could strengthen the anchor prostate imaging franchise, while the therapeutic pipeline provides longer-term optionality for the company.
The TLX591-Tx therapeutic pipeline cleared its Phase 3 Part 1 safety objectives earlier in 2026, with no treatment-related deaths and no new safety signals observed across combinations with abiraterone, enzalutamide, and docetaxel, setting up Part 2 enrollment across multiple global markets.
What comes next
With enrollment now complete, the next milestones for BiPASS would involve data readout and progression of the NDA pathway with the FDA. The announcement does not disclose specific data readout or NDA filing dates.
If BiPASS meets its objectives, precision imaging could become a critical step in initial diagnosis, expanding Telix’s addressable patient population beyond current staging and re-staging use. According to the company, the NDA pathway, if approved, would support reimbursement as a new product and broaden patient access to gallium-based PSMA-PET imaging.
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