Telix Completes Enrollment in Phase 3 BiPASS Study, Aligns with FDA on NDA Pathway
Rhea-AI Summary
Telix (ASX: TLX, NASDAQ: TLX) has completed enrollment of 350 patients in the Phase 3 BiPASS™ study, evaluating Illuccix® and Gozellix® (68Ga-PSMA-11 PET) combined with MRI for prostate cancer imaging in the pre-biopsy setting in the U.S. and Australia.
BiPASS is described as the first registrational 68Ga-PSMA-PET study in this setting and is designed to assess diagnostic performance, biopsy avoidance, and biopsy targeting versus current practice. Telix has also aligned with the U.S. FDA on an NDA pathway that, if approved, could support reimbursement as a new product and broaden access to 68Ga-PSMA-PET imaging for a substantially larger patient population, potentially building on prior PRIMARY and PRIMARY2 data.
Positive
- BiPASS Phase 3 enrollment completed with 350 patients in the U.S. and Australia
- FDA alignment on NDA pathway for BiPASS that could support new-product reimbursement in the U.S.
- First registrational pre-biopsy 68Ga-PSMA-PET study positioning Illuccix and Gozellix in an earlier diagnostic setting
Negative
- None.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 20 | Phase 3 trial initiation | Positive | +3.9% | First patient dosed in Phase 3 LUTEON trial for relapsed or recurrent renal cancer |
| Jul 01 | FDA trial alignment | Positive | +0.3% | FDA supported advancing ProstACT Global Phase 3 Part 2 in the United States |
| Jun 01 | Phase 3 trial data | Positive | -2.8% | ProstACT Global Phase 3 Part 1 results presented in a late-breaking ASCO oral session |
| Apr 21 | Phase 3 trial presentation | Positive | +1.0% | ProstACT Global Phase 3 Part 1 data selected for late-breaking ASCO 2026 presentation |
| Apr 14 | Phase 3 trial initiation | Positive | -0.4% | First patient dosed in pivotal Phase 3 IPAX-BrIGHT trial for recurrent glioblastoma |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical-trial milestones were more often aligned than divergent, although the historical record included both positive and negative reactions.
Key Terms
new drug application regulatory
psma-pet medical
open-label technical
histopathological evaluation medical
androgen deprivation therapy medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- The Phase 3 BiPASS™ study of Illuccix® and Gozellix® for prostate cancer imaging in the pre-biopsy setting has completed enrollment of 350 patients.
- Telix has positively engaged with the FDA on a New Drug Application (NDA) pathway in the U.S. that would support new product reimbursement and broaden access to 68Ga-PSMA-PET imaging across a significantly larger patient population.
- BiPASS is designed to evaluate the diagnostic performance of 68Ga-PSMA-11 PET combined with MRI for the detection of prostate cancer prior to biopsy.
MELBOURNE, Australia and INDIANAPOLIS, Sept. 02, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announced completion of patient enrollment in the Phase 3 BiPASS™ study of its commercial PSMA-PET1 imaging agents, Illuccix® (kit for the preparation of gallium Ga68 gozetotide injection) and Gozellix® (kit for the preparation of gallium Ga68 gozetotide injection) for prostate cancer imaging in the pre-biopsy setting. Telix has also aligned with the United States (U.S.) Food and Drug Administration (FDA) on a New Drug Application (NDA) pathway for BiPASS that, if approved, would support reimbursement as a new product and broaden patient access.
BiPASS (Biopsy of the Prostate Avoidance Stratification Study2) is the first registrational study of 68Ga-PSMA-PET imaging in the pre-biopsy setting. The study aims to evaluate whether the combination of MRI3 and PSMA-PET/CT4 with Telix’s proprietary 68Ga-PSMA-PET agents can further improve diagnostic accuracy, reduce unnecessary biopsies, or improve targeting of biopsy compared with current standard practice. A total of 350 patients were enrolled in the U.S. and Australia in this prospective, open-label Phase 3 trial.
Globally, more than three million prostate biopsies are performed each year5, yet up to
BiPASS builds on the clinical foundation established by the landmark PRIMARY9 and PRIMARY210 studies, which 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 percent. 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. Earlier and more accurate identification of clinically significant disease could improve patient selection and treatment decisions, reduce unnecessary biopsies, and potentially decrease the long-term patient burden and healthcare cost of prostate cancer recurrence. Successful implementation of BiPASS could broaden access to 68Ga-PSMA-PET imaging across a substantially larger patient population.
Professor Louise Emmett, Director of Theranostics and Nuclear Medicine, St Vincent’s Hospital and BiPASS Investigator, said, “Completing patient enrollment in BiPASS is an important milestone for men with suspected prostate cancer, particularly those with equivocal MRI findings. The PRIMARY and PRIMARY2 studies demonstrated that 68Ga-PSMA-PET, when used alongside MRI, can safely halve the number of biopsies required without missing clinically significant prostate cancer. BiPASS now has the potential to fundamentally change the current standard of care, streamlining the diagnostic pathway, accelerating treatment decision-making and helping to ensure that men receive the most appropriate therapy earlier in their treatment journey.”
Dr. Brian Mazzarella, Vice President of Research for Urology America and BiPASS Investigator added, “PSMA-PET imaging with tracers such as Illuccix and Gozellix has already changed how we stage and manage prostate cancer. By combining the functional information from PSMA-PET with the detailed anatomic information provided by MRI, we have an unprecedented opportunity to improve the detection of clinically significant prostate cancer and guide more informed diagnostic decisions. For patients, this approach has the potential to reduce unnecessary procedures, lower procedural risk, ease anxiety, and ultimately enable more precise, individualized treatment decision-making.”
Dr. David N. Cade, Telix Group Chief Medical Officer, commented, “Recruitment of BiPASS was completed rapidly, reflecting strong enthusiasm from clinicians and patients for a more accurate, non-invasive approach to diagnosis. We believe BiPASS may represent a transformative event in the management of prostate cancer, alongside the compelling data from the PRIMARY studies. Instead of asking how best to stage prostate cancer, clinicians may increasingly use advanced imaging to determine which men need to undergo biopsy in the first place. 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.”
About Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection)
Illuccix, after radiolabeling with 68Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level, and for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Risk for Misinterpretation
Image interpretation errors can occur with Illuccix PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
Imaging Prior to Initial Definitive or Suspected Recurrence Therapy
The performance of Illuccix for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of Illuccix for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.
Radiation Risks
Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.
ADVERSE REACTIONS
The safety of gallium Ga 68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <
In the VISION study, 1003 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). Adverse reactions occurring at ≥
Adverse reactions occurring at a rate of <
Injection site pain has been identified during post-approval use of ILLUCCIX.
DRUG INTERACTIONS
Androgen deprivation therapy and other therapies targeting the androgen pathway
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.
Please note that this information is not comprehensive.
Please see the Full Prescribing Information here.
About Gozellix® (kit for the preparation of gallium Ga 68 gozetotide injection)
Gozellix, after radiolabeling with 68Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Risk for Misinterpretation
Image interpretation errors can occur with GOZELLIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
Imaging Prior to Initial Definitive or Suspected Recurrence Therapy
The performance of GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of GOZELLIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.
Radiation Risks
Gallium Ga-68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.
Hypersensitivity Reactions to Sulfites
Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
ADVERSE REACTIONS
The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <
DRUG INTERACTIONS
Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established.
Please note that this information is not comprehensive.
Please see the Full Prescribing Information here.
About Telix Pharmaceuticals Limited
Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) is a commercial-stage global radiopharmaceutical company, advancing targeted theranostics to improve outcomes for people with cancer across the patient journey. Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease.
Telix's commercial franchise is anchored by its prostate cancer imaging portfolio: Illuccix®, commercially available in 22 countries including the U.S. and Gozellix®, approved by the FDA. The Company's late-stage therapeutic pipeline includes three investigational assets in pivotal-stage trials: TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx (131I-iodofalan) in recurrent glioblastoma, and TLX250-Tx (lutetium (177Lu) girentuximab tetraxetan) in kidney cancer, additionally complemented by a deep pipeline of next generation candidates.
Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. For more information, visit www.telixpharma.com or follow Telix on LinkedIn, X and Facebook.
| Investor Relations | Media | |
| Annie Kasparian annie.kasparian@telixpharma.com | Eliza Schleifstein 917.763.8106 (Mobile) Eliza@schleifsteinpr.com | |
| Charlene Jaw charlene.jaw@telixpharma.com | ||
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1 Imaging of prostate-specific membrane antigen with positron emission tomography.
2 ClinicalTrials.gov ID: NCT07052214.
3 Magnetic resonance imaging.
4 Imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography.
5 Hu et al. JAMA Oncol. 2024.
6 Vickers et al. J Clin Oncol. 2010.
7 Schaufler C et al. Urologic Oncology: Seminars and Original Investigations. 2022.
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