Telix Submits European Marketing Authorization Application for TLX101-Px for Brain Cancer Imaging

MELBOURNE, Australia and INDIANAPOLIS, Feb. 18, 2026 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that it 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.

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. The submission covers major European markets[1]. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines[2]. Submission of the U.S. New Drug Application (NDA) will follow.

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. However, there is currently no generally available commercial product in Europe that ensures consistent quality and access for glioma imaging, an acute and immediate need[3]. 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. 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 h