News & Views

Telix today welcomes the announcement by the United States (U.S.) Centers for Medicare & Medicaid Services (CMS) that it will pay separately for specialised diagnostic radiopharmaceuticals for Medicare Fee for Service patients in the hospital outpatient setting, beyond the transitional pass-through payment period (“pass-through”). This is a significant decision for patients and hospitals, with the change facilitating equitable access to advanced imaging agents for all patients into the future. 

Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara®), an agent for the imaging of glioma. The application has been granted priority review and designated a PDUFA goal date of 26 April 2025, paving the way for a U.S. commercial launch in 2025.

Telix announces that it has publicly filed a Form 20-F registration statement (Registration Statement) with the United States (U.S.) Securities and Exchange Commission (SEC) relating to a proposed listing of American Depository Shares (ADS), representing the Company’s ordinary shares, on the Nasdaq Stock Market (Nasdaq).

Telix today provides an update on its revenue and operational performance for the quarter ended 30 September 2024 (Q3 2024).

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

Telix today advises that it will release its financial results for the half-year ended 30 June 2024 on Thursday 22 August 2024.