TLX News & Events

Telix Pharmaceuticals announces a research collaboration with University Hospital Essen on the PROMISE-PET registry1, defining the potential prognostic value of PSMA-PET2 imaging through artificial intelligence. PROMISE-PET is a multi-center, prospective, observational, non-interventional registry study designed to enable research assessing the prognostic value of PSMA-PET and comparing it with established clinical risk scores in early and late stages of disease. The registry has been collecting and analyzing patient data since 2018 and, to date, PET readings from more than 15,000 patients across over 50 institutions globally have been standardized using the PROMISE framework, with PSMA-PET and PROMISE confirmed as a novel prognostic biomarker for prostate cancer using both internal and external validation cohorts. The aim of this new collaboration with Telix is to develop and validate AI-based prediction models for survival, leveraging gallium-68-PSMA-11-PET imaging data, using the automated machine learning engine that powers Telix's AI platform4, and comparing performance with established clinically prognostic nomograms. PSMA-PET imaging represents a significant advance in prostate cancer management and is now considered standard of care, offering greater accuracy than conventional imaging after initial diagnosis and for detecting recurrence5. However, there remains an opportunity to better understand whether PSMA-PET imaging data can be correlated to patient outcomes.

Telix Pharmaceuticals files to sell American Depositary Shares, no amount given

Telix Pharmaceuticals announces that it has submitted a marketing authorization application, or MAA, in Europe for TLX101-Px, its glioma imaging candidate. Telix has been preparing the European and U.S. regulatory packages for TLX101-Px concurrently, bringing forward the European submission to meet an agreed filing date while aligning with aspects of the FDA package to support the additional application. The submission covers major European markets1. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines2. Submission of the U.S. New Drug Application, or NDA, will follow. In Europe, positron emission tomography, or PET, imaging of glioma with 18F-FET is currently performed under physician-supervised use through hospital-based production at a limited number of sites. Telix aims to expand patient access to advanced imaging that can distinguish progressive or recurrent glioma from treatment-related changes in both adults and children, with potential for additional future indications. In Europe, approximately 67,500 brain and central nervous system tumors are diagnosed every year6, with gliomas accounting for approximately 30% of these, and up to 80% of all malignant brain tumors. There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumors of the central nervous system, particularly in the post-treatment setting.