TLX250-CDx (Zircaix) Included in Leading International Guidelines for Renal Imaging
MELBOURNE, Australia and INDIANAPOLIS, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ:TLX, "Telix") today welcomes updated guidelines from the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the European Association of Nuclear Medicine (EANM) and The American College of Nuclear Medicine (ACNM) that, for the first time, include the use of Telix's investigational PET1 agent, TLX250-CDx (Zircaix®2, 89Zr-DFO-girentuximab), for molecular imaging of renal masses.
Published on the SNMMI website3 and in The Journal of Nuclear Medicine4, the guideline panel5, comprising internationally renowned and multidisciplinary expert key opinion leaders, concludes that "the emerging use of molecular imaging for risk stratification of indeterminate renal masses offers the opportunity to more effectively characterize such lesions and optimize patient management decisions".
The panel asserts that antibody-based radiotracers exhibit lower renal clearance, thereby improving visualization of renal masses. It emphasizes that TLX250-CDx PET "appears to be a well-tolerated and accurate method for non-invasive identification of ccRCC6" and notes by contrast, the high renal excretion with 18F-FDG PET, which obscures accurate lesion detection.
The panel references data from Telix's pivotal Phase 3 ZIRCON trial7, which met all primary and secondary endpoints, demonstrating a sensitivity of 86%, specificity of 87% and a positive predictive value (PPV) of 93% for ccRCC, including in very small, difficult-to-detect lesions8. TLX250-CDx works by specifically binding to carbonic anhydrase IX (CAIX), a validated target protein expressed on >95% of ccRCC cells9, to produce images with high tumor-to-background ratio and high intra- and inter-reader consistency.
Professor Brian Shuch, MD, Director of the Kidney Cancer Program and the Alvin & Carrie Meinhardt Endowed Chair in Kidney Cancer Research at UCLA Institute of Urologic Oncology and guideline author, commented, "The recognition of 89Zr-girentuximab PET in the SNMMI/EANM/ACNM clinical guidelines reflects a shift toward precision medicine in renal cancer, providing clinicians with a more accurate tool for diagnosis to guide optimal, individualized treatment planning for patients."
Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, added, "The inclusion of TLX250-CDx PET imaging for the first time in SNMMI/EANM/ACNM guidelines is an important development for Telix and will help raise awareness of this breakthrough precision diagnostic. Subject to regulatory approval, endorsement by this expert global multidisciplinary panel will help to drive adoption and implementation into clinical workflows, supporting clinical utility and enhancing decision-making to improve patient outcomes."
SNMMI, EANM and ACNM periodically define new procedure standards/guidelines to help advance the science of nuclear medicine and to improve the quality of service to patients. Each standard/guideline, representing a policy statement by these groups undergoes a thorough consensus process in which it has been subjected to extensive review.
About TLX250-CDx
TLX250-CDx is an investigational PET agent that is under development for the diagnosis and characterization of ccRCC. Telix's pivotal Phase 3 ZIRCON trial evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% PPV for ccRCC across three independent radiology readers. Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC.
For more on TLX250-CDx and Telix's theranostic kidney cancer program, click here.
TLX250-CDx has not received a marketing authorization in any jurisdiction.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ:TLX).
Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix's first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA10.
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook
Telix Investor Relations (Global)
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: [email protected]
Telix Investor Relations (U.S.)
Annie Kasparian
Telix Pharmaceuticals Limited
Director Investor Relations and Corporate Communications
Email: [email protected]
Media Contact
Eliza Schleifstein
[email protected]
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; 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.
©2025 Telix Pharmaceuticals Limited. All rights reserved.
1 Positron emission tomography.
2 Brand name subject to final regulatory approval.
3 https://snmmi.org/common/Uploaded%20files/Web/Clinical%20Practice/Procedure%20Standards/2025/SNMMI_EANM_ACNM_Renal_Masses-Final%20JNM%20sumbission.pdf
4 SNMMI/EANM/ACNM Procedure Standard/Procedure Guideline on the Use of Molecular Imaging for Renal Mass Characterization (October 2025), available at: https://jnm.snmjournals.org/content/early/2025/10/09/jnumed.125.271332.abstract
5 Steven P. Rowe, Brian M. Shuch, Mark W. Ball, Axel Bex, Mehrbod S. Javadi, Alan Klitzke, Karolien Goffin, Peter Mulders, Neeta Pandit-Taskar, Ashwin Singh Parihar, Benjamin L. Viglianti, Michael A. Gorin, and Ken Herrmann.
6 Clear cell renal cell carcinoma, the most common and one of the most aggressive subtypes of kidney cancer.
7 ClinicalTrials.gov ID: NCT03849118.
8 Telix ASX disclosures 7 November 2022. Shuch et al. Lancet Oncology. 2024.
9 Stillebroer et al. Eur Urol. 2010.
10 Telix ASX disclosure 21 March 2025.
