First patient dosed in Phase 3 LUTEON1 trial evaluating TLX250-Tx in relapsed or recurrent clear cell renal cell carcinoma (ccRCC).LUTEON is the first Phase 3 study of a CAIX2-targeted radiopharmaceutical therapy in

Telix Doses First Patient in Phase 3 LUTEON Trial of TLX250-Tx for Renal Cancer

Telix Doses First Patient in Phase 3 LUTEON Trial for TLX250-Tx

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 <section data-block="information">
 <h3>Information</h3>
 First patient dosed in Phase 3 LUTEON1 trial evaluating TLX250-Tx in relapsed or recurrent clear cell renal cell carcinoma (ccRCC).LUTEON is the first Phase 3 study of a CAIX2-targeted radiopharmaceutical therapy in
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 <section data-block="ai-summary-paragraph">
 <h3>AI Summary</h3>
 Telix announced the first patient was dosed in LUTEON, its Phase 3 trial of TLX250-Tx for relapsed ccRCC. LUTEON is the first Phase 3 CAIX-targeted radiopharmaceutical therapy in ccRCC, using TLX250-Px imaging to identify eligible CAIX-positive tumors. The milestone could set the stage for data readouts and potential regulatory progression as Telix advances its CAIX-targeted radiopharmaceutical platform.
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 <section data-block="ai-summary-bullets">
 <h3>Key Points</h3>
 <ul><li>First patient dosed in TLX250-Tx Phase 3 LUTEON ccRCC trial.</li><li>LUTEON is the first Phase 3 CAIX-targeted radiopharmaceutical in ccRCC.</li><li>TLX250-Tx is Lu-177 radiopharmaceutical; CAIX expressed in &gt;95% ccRCC.</li><li>LUTEON ATLAS Phase 2a US/Europe; TLX250-Px imaging aids selection.</li></ul>
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 <section data-block="companies-mentioned">
 <h3>Companies Mentioned</h3>
 <ul><li>Telix Pharmaceuticals Limited (TLX): Phase 3 progress for TLX250-Tx could serve as a near-term catalyst; dual-listed on ASX and NASDAQ.</li><li>GenesisCare (N/A): Site of first-patient dosing; private clinic; no direct market impact.</li></ul>
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 <section data-block="category">
 <h3>Industry News</h3>
 Industry News; reflects a corporate development milestone in Telix&#039;s radiopharmaceutical pipeline, highlighting the progression of TLX250-Tx into Phase 3 and the broader CAIX-targeted strategy for ccRCC.
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 <section data-block="market-moving">
 <h3>Market-Moving</h3>
 <ul><li>First patient dosed in LUTEON Phase 3 could act as near-term catalyst.</li><li>LUTEON is the first Phase 3 CAIX-targeted radiopharmaceutical in ccRCC.</li><li>TLX250-Tx targets CAIX in &gt;95% of ccRCC, potentially improving patient selection.</li><li>LUTEON ATLAS US/Europe Phase 2a may enhance data visibility.</li></ul>
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 <section data-block="key-facts">
 <h3>Key Facts</h3>
 <ul><li>First patient dosed on July 21, 2026, at GenesisCare Murdoch (Australia).</li><li>LUTEON is a Phase 3, randomized, open-label, multi-center study in ccRCC.</li><li>TLX250-Tx is a Lu-177 radiopharmaceutical conjugated to girentuximab.</li><li>CAIX is expressed in more than 95% of ccRCC and limited in normal tissues.</li><li>ClinicalTrials.gov ID: NCT07197580.</li></ul>
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 <section data-block="trading-thesis">
 <h3>Trading Thesis</h3>
 Near-term bullish catalyst; TLX could move on LUTEON progress and future readouts over 12–24 months.
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<link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css"></link><ul type="disc"><li style="text-align:justify;">First patient dosed in Phase 3 LUTEON1 trial evaluating TLX250-Tx in relapsed or recurrent clear cell renal cell carcinoma (ccRCC).</li><li style="text-align:justify;">LUTEON is the first Phase 3 study of a CAIX2-targeted radiopharmaceutical therapy in ccRCC.</li></ul> MELBOURNE (Australia) and INDIANAPOLIS, July 21, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/TLX">TLX</a>, "Telix") today announced that the first patient has been dosed with TLX250-Tx (lutetium-177 (177Lu) girentuximab tetraxetan) in the LUTEON study, the first radiopharmaceutical therapy to enter Phase 3 development for ccRCC. LUTEON is a randomized, prospective, open label, multi-center study evaluating a CAIX-targeting radionuclide therapy in patients with relapsed or recurrent ccRCC. The patient was dosed at GenesisCare Murdoch (Western Australia), under the supervision of Dr. Aviral Singh. Dr. Aviral Singh, Clinical Head of Theranostics and Nuclear Medicine at GenesisCare Murdoch and Principal Investigator on the LUTEON trial, commented, "Dosing the first patient in the LUTEON study marks an important milestone in the development of potential new treatment options for patients with relapsed or recurrent clear cell renal cell carcinoma. Despite advances in care, outcomes remain poor for many patients, underscoring the need for innovative therapeutic approaches. This study will play a critical role in evaluating the safety, tolerability and efficacy of this investigational CAIX-targeted radiopharmaceutical for patients globally, and we look forward to helping advance the clinical evidence for this promising therapeutic candidate." Dr. David N. Cade, Telix Group Chief Medical Officer, added, "LUTEON represents the next stage in Telix’s global clinical development of TLX250-Tx and reflects our commitment to developing precision radiopharmaceuticals for patients with difficult-to-treat cancers. We aim to further evaluate the potential of TLX250-Tx that is designed to utilize the high prevalence of CAIX expression in ccRCC to deliver targeted radiation directly to tumor sites, while limiting exposure to healthy tissue." About TLX250-Tx TLX250-Tx is a first-in-class CAIX-targeting rADC3 therapy candidate composed of a high-specificity monoclonal antibody chelated to the therapeutic radionuclide lutetium-177. CAIX is an attractive therapeutic target because it is expressed in more than 95% of ccRCC, while demonstrating limited expression in normal tissues, including kidney tissue4,5. LUTEON is being run under a Phase 3 protocol in Australia and forms part of Telix&#39;s global development program for TLX250-Tx, which includes the separate Phase 2a LUTEON ATLAS study in the United States and Europe. The LUTEON study utilizes Telix’s investigational PET6 imaging agent, TLX250-Px (Zircaix&#xAE;7, zirconium-89 (89Zr) girentuximab senvedoxam), to identify eligible patients with CAIX-positive tumors. About clear cell Renal Cell Carcinoma Renal Cell Carcinoma, RCC, is the most common form of kidney cancer, accounting for approximately 9 out of 10 diagnoses8. Within this category, ccRCC is the most common and often the most aggressive subtype, representing about 85% of all RCC cases9 with up to 30% of patients presented with metastatic disease at diagnosis, which has a 20% 5-year survival rate10,11. About Telix Pharmaceuticals Limited  Telix Pharmaceuticals ((ASX: TLX, NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/TLX">TLX</a>) 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&#39;s commercial franchise is anchored by its prostate cancer imaging portfolio: Illuccix&#xAE; (kit for the preparation of gallium-68 gozetotide injection), commercially available in 22 countries including the U.S. and Gozellix&#xAE; (kit for the preparation of gallium-68 gozetotide injection), approved by the U.S. Food and Drug Administration (FDA). The Company&#39;s late-stage therapeutic pipeline includes three assets in pivotal-stage trials - TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx (131I-iodofalan) in recurrent glioblastoma, TLX250-Tx (lutetium (177Lu) girentuximab tetraxetan) in kidney cancer, complemented by a deep pipeline of next generation assets. TLX250-Tx and TLX250-Px have not received a marketing authorization in any jurisdiction. Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. For more information, visit <a href="https://www.globenewswire.com/Tracker?data=xBcshiD94vhXn0DWgoF5g_gew-zqSuST6g51zOk_njWH0RvnrSMATMvTAY7kSuYOftKh8C7qt35JeiXTuq75BZpKTaHfrUQzhPhhdJ0YctQ=" rel="nofollow" target="_blank">www.telixpharma.com</a> or follow Telix on <a href="https://www.globenewswire.com/Tracker?data=1pQYo0AV6HGiqBJUOqeNKgkL4QMqJh4D1pdXCcE2zro96i7pofmP4DNaQYt3kYaEEhjcwoy8FAE2ZBmStLL09DyHzJ4j7dLYs6aIy2RkgFNHosbrU5UvBw5OiiDjcNF0" rel="nofollow" target="_blank">LinkedIn</a>, <a href="https://www.globenewswire.com/Tracker?data=pHgJibzWTomp4T9_AIkeeVMFfscVbbdR6qMJKKzVfT0SRUcgZ7hfiu0NBdYYrR3qOBer0txImnwJ2hYOXCowiQ==" rel="nofollow" target="_blank">X</a> and <a href="https://www.globenewswire.com/Tracker?data=-IbN4ndvXq3DjlfSg1jDVP22faZkGmmzrob9u_48FScN-5r6IcamUrhM5eALTkO0o093oXZVmzLZMSARvEuxwwHtWBO7zo4nCzBw8yuwIhE=" rel="nofollow" target="_blank">Facebook</a>. <table style="border-collapse: collapse; width:100%; border-collapse:collapse ;"><tr><td style="max-width:50%; width:50%; min-width:50%;;text-align: justify ; vertical-align: middle; vertical-align: top ; ">Investor Relations Annie Kasparian <a href="mailto:Annie.kasparian@telixpharma.com" rel="nofollow" target="_blank">Annie.kasparian@telixpharma.com</a> Charlene Jaw <a href="mailto:Charlene.jaw@telixpharma.com" rel="nofollow" target="_blank">Charlene.jaw@telixpharma.com</a> </td><td style="max-width:50%; width:50%; min-width:50%;;text-align: justify ; vertical-align: middle; vertical-align: top ; ">Media Eliza Schleifstein <a href="mailto:Eliza@schleifsteinpr.com" rel="nofollow" target="_blank">Eliza@schleifsteinpr.com</a> </td></tr><tr><td> </td><td> </td></tr></table> 1 ClinicalTrials.gov ID: <a href="https://www.globenewswire.com/Tracker?data=cuEqTZASax1m79iyfYimF8Q73lQM_W3VRPUnLuKxoFhfBGbRSjD8rh41_2VTWGSesUrIMqLgYm8tMvMxZesHbg0j91WD_8UcDqKIFkJB3-xpcmCOQ-Yg-vCOCGkXAJOJ" rel="nofollow" target="_blank">NCT07197580</a>. 2 Carbonic Anhydrase IX. 3 Radio antibody-drug conjugate. 4 Luong-Player A, et al. Am J Clin Pathol. 2014. 5 Kleinendorst SC, et al. Theranostics. 2024. 6 Positron emission tomography. 7 Brand name subject to final regulatory approval. 8 Bukavina, L, et al. Eur Urol. 2022. 9 Alchahin AM, et al. Nat Commun. 2022. 10 National Cancer Institute. Cancer stat facts: kidney and renal pelvis cancer. Updated 2025. Accessed May 1, 2026. <a href="https://www.globenewswire.com/Tracker?data=NZLWaTSxk5WMKZ9yterzo4zg32Vo6D--wuiaMx4rt4ML1CacPG2djxH3IaCE8bcBWmrR_2a0JxQrze1LRbV1sE-DsHy3tuSiTjdmqu7HdhIzl8KejV9KtClqVDlelR3l22gzeKLedJHesbPSJ-EQbgkcgibhXX8XdorN24OJ6O0=" rel="nofollow" target="_blank">https://seer.cancer.gov/statfacts/html/kidrp.html</a>. 11 Vento JA, et al. Cancers (Basel). 2022. 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. 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Telix announced the first patient was dosed in LUTEON, its Phase 3 trial of TLX250-Tx for relapsed ccRCC. LUTEON is the first Phase 3 CAIX-targeted radiopharmaceutical therapy in ccRCC, using TLX250-Px imaging to identify eligible CAIX-positive tumors. The milestone could set the stage for data readouts and potential regulatory progression as Telix advances its CAIX-targeted radiopharmaceutical platform.

Telix Doses First Patient in Phase 3 LUTEON Trial of TLX250-Tx for Renal Cancer

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