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

Telix Pharmaceuticals Limited 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, on February 18, 2026. The submission covers major European markets, with the French National Agency for Medicines and Health Products Safety (ANSM) acting as Reference Member State. Submission of the U.S. New Drug Application (NDA) will follow.

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. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines.

TLX101-Px is a positron emission tomography (PET) imaging candidate for the characterization of glioma. The agent targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). 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. and is the subject of the Phase 3 IPAX-BrIGHT trial in patients with recurrent glioblastoma, launching in multiple European countries. TLX101-Px enables the agent to be potentially utilized as a complementary diagnostic agent to TLX101-Tx, Telix's LAT1-targeting investigational glioblastoma (GBM) therapy, currently under investigation in Telix's IPAX-2 and IPAX-BrIGHT studies.

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.

The Chief Executive Officer of Telix Precision Medicine stated, "We see a compelling opportunity in Europe to broaden access to authorized targeted radiopharmaceuticals for brain cancer imaging and therapy, and as such this submission is an important milestone for Telix. The strategic value of this submission is particularly relevant to establishing widespread glioma imaging as part of our corresponding therapeutic development program. We have been able to utilize aspects of our FDA package to expedite the European filing, which has been submitted in accordance with a pre-defined date agreed with the regulator, with the U.S. resubmission to follow."

A Group Leader at Forschungszentrum Jülich research center in Germany commented, "FET-PET imaging is already used in clinical practice in Europe for the evaluation of gliomas, and plays a critical role in treatment decision making. This applies particularly in the post-therapy setting, where conventional MRI alone can be limited in its ability to distinguish tumor progression from treatment-related changes. Having widespread access to TLX101-Px has potential to provide clinicians with greater biological insight, supporting more confident and timely management of patients with brain tumors."

In Europe, approximately 67,500 brain and central nervous system tumors are diagnosed every year, 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. Conventional MRI imaging techniques have several limitations, including a lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumor progression or treatment-related causes. This can yield inconclusive results and delay time-sensitive treatment decisions. With low survival rates and the need to make rapid decisions, precision imaging is paramount.

Subject to regulatory approval, TLX101-Px has the potential to address this need, enabling patients in Europe to receive greater clarity in their diagnosis and treatment decision making. In relevant European markets, the proposed brand name for TLX101-Px is "Pixlumi®". Brand name and commercial launch are subject to final regulatory approval. TLX101-Px and TLX101-Tx have not received a marketing authorization in any jurisdiction.

Telix shares rose 1.9% in after-hours trading following the announcement.