• Telix submits marketing authorization application (MAA) in Europe for TLX101-Px, its glioma (brain cancer) imaging candidate
• Submission covers major European markets, aims to expand patient access to advanced brain imaging
• TLX101-Px is also being developed as a patient selection and response assessment tool for Telix's glioblastoma therapy candidate TLX101-Tx

Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) 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. The submission covers major European markets and aims to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines. 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 U.S. Food and Drug Administration (FDA) package to support the additional application. In Europe, positron emission tomography (PET) imaging of glioma with 18F-FET (FET-PET) is currently performed under physician-supervised use through hospital-based production at a limited number of sites, but there is currently no generally available commercial product in Europe that ensures consistent quality and access for glioma imaging, an acute and immediate need. Telix aims to address this unmet need and enable patients in Europe to receive greater clarity in their diagnosis and treatment decision making. TLX101-Px is also being developed as a patient selection and response assessment tool for Telix's glioblastoma therapy candidate TLX101-Tx (iodofalan 131I), which has been granted orphan drug designation in Europe and the U.S. and is the subject of the Phase 3 IPAX-BrIGHT trial in patients with recurrent glioblastoma, launching in multiple European countries.