News & Views | Telix Pharmaceuticals Limited

FDA Approves Expanded Indication for Telix’s Illuccix® to Include Patient Selection for PSMA-Directed Radioligand Therapy

Telix Pharmaceuticals today announces that the United States Food and Drug Administration (FDA) has approved a supplementary New Drug Application (sNDA) for Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) to enable its use for the selection of patients with metastatic prostate cancer, for whom 177Lu 177 PSMA-directed therapy is indicated.

Telix’s ZIRCON Phase III Kidney Cancer Imaging Study Presented in “Game Changing” Session at EAU

Telix today announces additional positive results from its completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118).

Telix to Showcase Additional ZIRCON Phase III Data in Kidney Cancer Imaging and Theranostic Pipeline Developments at EAU

Telix today announces presentations from the Company’s carbonic anhydrase IX (CAIX) targeting kidney and bladder cancer programs at the 38th Annual European Association of Urology (EAU) Congress to be held in Milan from 10 – 13 March 2023.

Telix 2022 Full Year Results: Revenue up 20x in first year of commercial sales, underpins transition to cash flow positive

Telix today announces its financial results for the financial year ended 31 December 2022.

Webcast of Investor Briefing: ASCO GU ZIRCON Phase III Results Presentation

Telix is pleased to provide a webcast recording of A/Prof Brian Shuch and Dr Colin Hayward, Telix Group Chief Medical Officer. The briefing provided an opportunity for investors to hear Dr Shuch’s ASCO-GU presentation and a clinician’s perspective on the clinical utility of this investigational imaging agent.

Telix 2022 Full Year Results and Investor Call / Webcast Notification

Telix today advises it will release its Full Year Results and Annual Report for the period ended 31 December 2022 on Monday 27 February 2023 at market close.

Detailed Results from Telix’s ZIRCON Phase III Kidney Cancer Imaging Study Presented at ASCO GU

Telix today announces detailed positive results from its completed pivotal Phase III ZIRCON trial (ClinicalTrials.gov Identifier: NCT03849118)1. The study met primary and secondary endpoints, with TLX250-CDx demonstrating the ability to reliably characterise and detect the clear cell phenotype and provide a non-invasive method of diagnosing the presence and spread of ccRCC, delivering on an unmet medical need in this disease setting.

Telix Collaboration on Next Generation Urologic-Oncology Theranostic Published in Journal of Nuclear Medicine

Telix today announces the successful completion of its joint research project conducted with Heidelberg University Hospital (UKHD) under the Research Cooperation Agreement announced in February 2021.1 The aim of this project was to create and validate a generator-based theranostic compound for urologic oncology targeting PSMA2 and utilising the beta-emitting isotope rhenium-188 (188Re).

Notification of Investor Briefing: ASCO-GU ZIRCON Phase III Results Presentation

Telix advises that Associate Professor Brian Shuch, MD, Director, Kidney Cancer Program, UCLA Institute of Urologic Oncology (Los Angeles, California) and a Principal Investigator in the Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) will be delivering an oral abstract presentation to the 2023 ASCO GU Symposium being held in San Francisco, CA, on Saturday 18 February at 2.00pm – 2.10pm PDT as the first presentation in the Renal and Rare Tumors session.

Activities Report and Appendix 4C for December quarter

Telix today issues its Appendix 4C quarterly cash flow statement and accompanying Activities Report for the quarter ended 31 December 2022 (Q4 2022). All figures are in AUD$ unless otherwise stated1 and provided on an unaudited basis.