Telix completes enrollment in Phase 3 BiPASS study
FDA alignment on the BiPASS NDA pathway could, if approved, enable reimbursement and expand access to gallium-PSMA PET imaging.
Rhea-AI Filing Summary
Telix Pharmaceuticals Ltd (TLX) reports completion of patient enrollment in its Phase 3 BiPASS study, evaluating Illuccix and Gozellix 68Ga‑PSMA‑PET imaging combined with MRI for prostate cancer diagnosis in the pre‑biopsy setting. The prospective, open‑label trial enrolled 350 patients in the U.S. and Australia. Telix has also aligned with the U.S. FDA on a New Drug Application (NDA) pathway for BiPASS that, if approved, could support reimbursement as a new product and broaden patient access to gallium‑based PSMA‑PET imaging. BiPASS builds on PRIMARY and PRIMARY2 data showing that adding 68Ga‑PSMA‑PET to MRI can significantly improve detection of clinically significant prostate cancer while reducing unnecessary biopsies by almost 50 percent, with the potential to shift PSMA‑PET into an earlier, diagnostic role.
Positive
- Phase 3 BiPASS enrollment completed (350 patients), advancing Telix’s prostate cancer imaging program toward a registrational data readout in the pre‑biopsy setting.
- Alignment with FDA on an NDA pathway for BiPASS could, if approved, support new product reimbursement and broaden access to gallium‑based PSMA‑PET imaging for a larger patient population.
Negative
- None.
Filing Explained
The
Key Figures
BiPASS enrollment: 350 patients
Global prostate biopsies: More than 3,000,000 biopsies per year
Negative biopsy rate: Up to 75%
+2 more
5 metrics
BiPASS enrollment
350 patients
Total patients enrolled in the Phase 3 BiPASS trial in the U.S. and Australia
Global prostate biopsies
More than 3,000,000 biopsies per year
Estimated number of prostate biopsies performed globally each year
Negative biopsy rate
Up to 75%
Portion of prostate biopsies reported as negative in cited data
Patients declining biopsy
Approximately 25%
About one in four patients decline a recommended prostate biopsy
Reduction in unnecessary biopsies
Almost 50%
PRIMARY and PRIMARY2 data on biopsy reduction using 68Ga‑PSMA‑PET plus MRI
Key Terms
New Drug Application (NDA), 68Ga-PSMA-PET, theranostics, prostate-specific membrane antigen, +1 more
5 terms
New Drug Application (NDA) regulatory
"Telix has positively engaged with the FDA on a New Drug Application (NDA) pathway"
A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.
68Ga-PSMA-PET medical
"BiPASS is designed to evaluate the diagnostic performance of 68Ga-PSMA-11 PET combined with MRI"
A 68Ga-PSMA-PET is a medical imaging test that uses a tiny amount of radioactive gallium-68 attached to a molecule that seeks out PSMA, a marker often found on prostate cancer cells; the scan acts like a specialized camera that lights up cancer locations inside the body. For investors, it matters because use of this diagnostic changes how patients are staged and treated, drives demand for imaging agents, scanners and related services, and can affect clinical trial design and regulatory decisions tied to oncology products.
theranostics medical
"advancing targeted theranostics to improve outcomes for people with cancer"
Theranostics combines a medical test with a targeted treatment so the same approach both finds disease and delivers therapy—like a guided missile that first locates a target then destroys it. For investors, it matters because pairing diagnosis and therapy can speed identification of patients who will benefit, reduce wasted treatments, create dual revenue streams (tests plus drugs), and alter regulatory and reimbursement dynamics that affect commercial potential.
prostate-specific membrane antigen medical
"Imaging of prostate-specific membrane antigen with positron emission tomography"
A protein that sits on the surface of prostate cells, often much more abundant on prostate cancer cells, used as a biological “flag” that diagnostic scans and targeted treatments can home in on. Investors care because products that detect or bind this marker—like imaging agents or targeted drugs—can improve diagnosis and therapy, create new revenue streams, and face regulatory milestones that materially affect a company’s value.
precision imaging medical
"establish precision imaging as a critical step in initial diagnosis"
FAQ
What did Telix Pharmaceuticals (TLX) announce regarding the Phase 3 BiPASS study?
Telix announced completion of enrollment of 350 patients in the Phase 3 BiPASS trial of Illuccix and Gozellix 68Ga‑PSMA‑PET imaging combined with MRI for prostate cancer diagnosis in the pre‑biopsy setting, across sites in the United States and Australia.
How has Telix (TLX) engaged with the FDA on the BiPASS program?
Telix has aligned with the U.S. FDA on a New Drug Application (NDA) pathway for BiPASS that, if approved, would support reimbursement as a new product and broaden patient access to gallium‑based PSMA‑PET prostate cancer imaging.
What is the goal of the BiPASS study for Telix (TLX)?
BiPASS aims to evaluate 68Ga‑PSMA‑PET plus MRI before biopsy to see if this combination can improve diagnostic accuracy, reduce unnecessary biopsies, or improve biopsy targeting compared with current standard practice for suspected prostate cancer.
How many prostate biopsies are performed annually, according to Telix (TLX)?
Telix cites data indicating that more than three million prostate biopsies are performed globally each year, with up to 75% found to be negative, highlighting the need for better diagnostic tools such as BiPASS.
What prior evidence supports Telix’s BiPASS strategy?
The PRIMARY and PRIMARY2 studies showed that combining 68Ga‑PSMA‑PET with MRI can significantly improve detection of clinically significant prostate cancer and reduce unnecessary biopsies by almost 50%, forming the clinical foundation for BiPASS.
What products from Telix (TLX) are used in the BiPASS study?
BiPASS uses Telix’s commercial PSMA‑PET imaging agents Illuccix and Gozellix, both kits for preparation of gallium Ga68 gozetotide injection, to image prostate‑specific membrane antigen in men with suspected prostate cancer prior to biopsy.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Telix Pharmaceuticals Limited ACN 616 620 369 55 Flemington Road North Melbourne Victoria, 3051 Australia ASX ANNOUNCEMENT Page 1 Telix Completes Enrollment in Phase 3 BiPASS Study, Aligns with FDA on NDA Pathway • 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, IN (U.S.) – September 2, 2026. 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 MRI 3 and PSMA-PET/CT 4 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 75% are found to be negative6. Patient compliance remains a significant clinical challenge with approximately one in four patients declining a physician recommendation to undergo biopsy7. Biopsy is often stressful and painful, may lead to complications, and delivers no real diagnostic benefit for many patients8. 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 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. 8 Durkan G et al. Prostate Cancer Prostatic Dis. 2000. 9 Emmett et al., Eur Urol. 2021. 10 Buteau et al. Lancet Oncol. 2026. ClinicalTrials.gov ID: NCT05154162.
Page 2 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 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.
Page 3 Investor Relations Annie Kasparian annie.kasparian@telixpharma.com Charlene Jaw charlene.jaw@telixpharma.com Media Eliza Schleifstein 917.763.8106 (Mobile) Eliza@schleifsteinpr.com This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices Cautionary Statement Regarding Forward-Looking Statements. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business, including as a result of war or other geopolitical conflicts; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward- looking statements. Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties. ©2026 Telix Pharmaceuticals Limited. All rights reserved.