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TLX591-Tx: ​Development overview and data highlights

As a resource for analysts and investors, Telix has published a clinical data summary for TLX591-Tx (lutetium-177 rosopatamab tetraxetan), its investigational PSMA-targeted radio antibody-drug conjugate (rADC) for metastatic castration-resistant prostate cancer (mCRPC). The summary covers established dosimetry, safety, and efficacy data from the ProstACT SELECT Phase 1 study and prior clinical studies, as well as the design of the ongoing ProstACT GLOBAL Phase 3 trial.
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FY 2025 Results: Strong Commercial Growth, Focused Pipeline Investment

Telix today announces its financial results for the year ended December 31, 2025.
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Telix Submits European Marketing Authorization Application for TLX101-Px for Brain Cancer Imaging

Telix today announces that it has submitted a marketing authorization application (MAA) in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, 18F-FET), its glioma (brain cancer) imaging candidate.
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Telix Full Year Results 2025 Investor Webcast Notification

Telix advises that it will release its full year results for the period ended 31 December 2025 on Friday 20 February 2026 AEDT (Thursday 19 February 2026 EST).
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First Patient Dosed in Pivotal Phase 3 Study of TLX591-Px (Illuccix®) for Prostate Cancer Imaging in Japanese Patients

Telix today announces that the first patient has been dosed in the Phase 3 registration study of TLX591-Px (Illuccix®, Kit for the preparation of 68Ga-PSMA-11) for prostate cancer imaging in Japanese patients. The patient was dosed at Shonan Kamakura General Hospital (SKGH) in Kamakura, Japan.
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Telix Achieves FY 2025 Guidance with US$804M (A$1.2B) Revenue, Accelerates Growth with Gozellix Launch

Telix provides an update on its commercial and operational performance for the quarter ended 31 December 2025 (Q4 2025).
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Chinese NMPA Accepts New Drug Application for Illuccix for Prostate Cancer Imaging

Telix today announces that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has accepted the filing of a New Drug Application (NDA) for TLX591-Px (Illuccix®, Kit for the preparation of 68Ga-PSMA-11), Telix’s lead prostate cancer imaging agent.
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First U.S. Patient Dosed in BiPASS: Phase 3 Prostate Cancer Diagnosis Study

Telix today announces that the first patient in the United States (U.S.) has been dosed in BiPASS™ (Biopsy of the Prostate Avoidance Stratification Study), Phase 3 trial to  evaluate the use of Telix’s commercial PSMA-PET imaging agents, Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) and Gozellix® (kit for the preparation of gallium Ga 68 gozetotide injection) in the initial prostate cancer diagnosis setting. The dose was administered under the supervision of Dr. Brian Mazzarella at Urology Austin and supplied by RLS Radiopharmacies.
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Presentation to J.P. Morgan Healthcare Conference

Telix is pleased to provide a copy of the presentation that will be delivered by Dr. Christian Behrenbruch, Managing Director and Group CEO at the 44th Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA (U.S.).
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ZIRDOSE-CP Study of TLX250-CDx published in EJNMMI Research: Confirms Favorable Safety and Tolerability Profile in Chinese patients

Telix today announces that final results from the ZIRDOSE-CP Phase 1 study of TLX250-CDx (Zircaix®, 89Zr-girentuximab) PET imaging in Chinese patients with suspected clear cell renal cell carcinoma (ccRCC) have been published in the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) Research.
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