News & Views | Telix Pharmaceuticals Limited

Australian TGA Approves Additional Indication for Telix’s Illuccix® to Include Patient Selection for PSMA-Targeted Therapy

Telix today announces that the Australian Therapeutic Goods Administration (TGA) has approved the use of Illuccix® (kit for the preparation of 68Ga-PSMA-11[1] injection) to select patients for PSMA[2]-targeted radionuclide therapy.

Health Canada Approves Label Expansion for Telix’s Illuccix® to Include Patient Selection for PSMA-Targeted Therapy

Telix today announces that Health Canada has approved the use of Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) in selecting patients for PSMA[1]-targeted radionuclide therapy.

First Patient Dosed in Phase II ‘CA-NINE’ Trial of TLX250-CDx for Detection of Recurrent Kidney Cancer After Surgery

Telix today announces that the first patient has been dosed in a Phase II trial exploring the clinical utility of Telix’s first-in-class investigational PET[1] agent, TLX250-CDx (89Zr-girentuximab) in recurrent clear cell renal cell carcinoma (ccRCC) after surgery.

Telix to Acquire RLS to Expand North American Manufacturing and Distribution Platform

Telix and RLS (USA) Inc., America’s only Joint Commission-accredited radiopharmacy network distributing PET, SPECT and therapeutic radiopharmaceuticals, today announced an agreement by the Company to acquire RLS from its parent company, RLS Group Ltd. The acquisition significantly expands Telix’s North American manufacturing footprint and establishes the basis of a next generation radiometal production network to benefit Telix and select strategic commercial partners.

Telix Announces Cardinal Health as U.S. Commercial Distributor for Zircaix®

Telix today announces that it has selected Cardinal Health, Inc. (NYSE: CAH, Cardinal Health) as a commercial radiopharmaceutical distributor to supply finished unit doses of its PET agent, Zircaix® (TLX250-CDx) for the imaging of kidney cancer in the United States (U.S.), subject to regulatory approval.

‘Highly Accurate’: Telix’s Phase III ZIRCON Trial for Kidney Cancer Imaging Published in The Lancet Oncology

Telix today announces that primary results from its Phase III ZIRCON trial have been published in The Lancet Oncology, reporting that Telix’s first-in-class investigational PET agent, TLX250-CDx (Zircaix®, 89Zr-girentuximab), is highly accurate in detecting and characterising clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses (IRMs).

IPAX-1 Study of TLX101 Investigational Glioblastoma Therapy Published in Neuro-Oncology Advances

Telix today announces that the Company’s IPAX-1 Phase I study has been published in Neuro-Oncology Advances, confirming the safety and tolerability profile, and early efficacy of TLX101 therapy, in combination with external beam radiation therapy (EBRT) in recurrent glioblastoma (GBM), the most common and aggressive form of primary brain cancer.

Telix Submits NDA for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent

Telix today announces it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-CDx, (Pixclara®[1], 18F-floretyrosine or 18F-FET), an investigational PET[2] agent for the characterisation of progressive or recurrent glioma (brain cancer) from treatment related changes in both adult and pediatric patients.

Telix Announces Reorganisation to Deliver on Strategic Priorities

Telix today announces new leadership appointments as part of an internal reorganisation to align its operations across four business units, reflecting its focus as a therapeutics-led radiopharmaceutical company committed to precision oncology.

Telix 2024 Half-Year Results: Strong Commercial Revenue and Profit Growth to Support Strategic Priorities

Telix today announces its financial results for the half-year ended 30 June 2024. All figures are in AU$ unless otherwise stated.