Telix receives European acceptance for brain cancer imaging drug

MELBOURNE, Australia and INDIANAPOLIS, May 1, 2026 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that the marketing authorization application (MAA) filed in Europe for TLX101-Px (O-(2-[¹⁸F]fluoroethyl)-L-tyrosine, ¹⁸F-FET), its glioma (brain cancer) imaging candidate^[1], has been validated and accepted for review.

The application, covering commercially significant European markets^[2], has now moved into a 210-day active assessment phase^[3]. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines^[4]. Assuming a positive outcome from the application at Day 210, national marketing authorizations are expected to follow shortly after.

In Europe, there is currently no generally available commercial product for PET^[5] imaging of glioma with ¹⁸F-FET ("FET-PET"), resulting in an acute and immediate need for a consistent, high-quality product ^[6]. Through this MAA, 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 has been granted orphan drug designation in Europe and the U.S. The Phase 3 IPAX-BrIGHT^[7] trial of TLX101-Tx in patients with recurrent glioblastoma has commenced patient dosing internationally^[8] and is launching in multiple European countries.

Sied Kebir, MD, Head of Clinical Neuro-Oncology, University Hospital Essen, said: "In our day-to-day practice, one of the hardest questions we face is whether a change on conventional imaging reflects tumor progression or a treatment-related effect. PET imaging with ¹⁸F-FET can be used to help resolve this dilemma. The acceptance of this application is a welcome step toward broader, standardized patient access across Europe, and more timely and accurate decision-making."

Raphaël Ortiz, Chief Executive Officer, Telix International, commented, "The acceptance of our European MAA represents a significant regulatory milestone for Telix and for TLX101‑Px. It supports a critical unmet need for widely accessible glioma imaging for both diagnostic evaluation and therapeutic decision‑making. Subject to regulatory approval, we are preparing to bring this powerful precision medicine product to market in both Europe and the United States, where our new drug application has recently been accepted^[9]."

[1] Telix ASX disclosure February 18, 2026.

[2] The French National Agency for Medicines and Health Products Safety (ANSM), in its capacity as Reference Member State, is responsible for coordinating and leading the scientific evaluation of the dossier, in collaboration with the concerned Member States, nominated by Telix and representing the major European markets for Telix's brain cancer imaging product.

[3] 210-day assessment phase excludes clock-stop.

[4] Galldiks et al. Lancet Oncol. 2025 (Joint guidelines from the European Association of Nuclear Medicine (EANM), European Association of Neuro-Oncology (EANO), Society of Nuclear Medicine and Molecular Imaging (SNMMI), Response Assessment in Neuro-Oncology (RANO), The European Society for Pediatric Oncology and The Response Assessment in Pediatric Neuro-Oncology for the characterization of recurrence in glioma patients); National Comprehensive Cancer Network® ("NCCN") Clinical Practice Guidelines in Oncology ("NCCN Guidelines®") for Central Nervous System Cancers V1.2025.

[5] Positron emission tomography.

[6] Albert et al. Lancet Oncol. 2024.

[7] ClinicalTrials.gov ID: NCT07100730.

[8] Telix media release April 15, 2026.

[9] Telix ASX disclosure April 10, 2026.