Telix submits European marketing authorisation application for TLX101-Px for brain cancer imaging

Telix Pharmaceuticals

18 February 2026 - Telix today announces that it has submitted a marketing authorisation application 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 US regulatory packages for TLX101-Px concurrently, bringing forward the European submission to meet an agreed filing date while aligning with aspects of the US FDA package to support the additional application. The submission covers major European markets. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines. Submission of the US new drug application will follow.

Read Telix Pharmaceuticals press release

Michael Wonder

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Michael Wonder