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]."

About glioma in Europe

In Europe, approximately 67,500 brain and central nervous system tumors are diagnosed every year^[10], with gliomas accounting for approximately 30% of these, and up to 80% of all malignant brain tumors^[11]. 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 setting⁴. 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^[12]. With low survival rates and the need to make rapid decisions, precision imaging is paramount⁶. Subject to regulatory approval, TLX101-Px has the potential to address this need, enabling patients in Europe and worldwide to receive greater clarity in their diagnosis and treatment decision making.

About TLX101-Px

TLX101-Px (O-(2-[¹⁸F]fluoroethyl)-L-tyrosine) is Telix's PET imaging candidate for the characterization of glioma. TLX101-Px targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). This enables TLX101-Px to be potentially utilized as a patient selection and response assessment tool for TLX101-Tx (iodofalan ¹³¹I), Telix's LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in Telix's IPAX-2^[13] and IPAX-BrIGHT studies. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction. In relevant European markets, the proposed brand name for TLX101-Px is "Pixlumi®". Brand name and commercial launch are subject to final regulatory approval.

About Telix Pharmaceuticals Limited

Telix is a global biopharmaceutical company focused on the development and commercialization of radiopharmaceuticals with the goal of addressing significant unmet medical need in oncology and rare diseases. Telix is headquartered in Melbourne (Australia) with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland) and Japan. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.

Telix Investor Relations (Global) Ms. Kyahn Williamson SVP Investor Relations and Corporate Communications kyahn.williamson@telixpharma.com

Telix Investor Relations (U.S.)   Ms. Annie Kasparian   Director Investor Relations and Corporate Communications   annie.kasparian@telixpharma.com

Telix Investor Relations (Australia) Ms. Charlene Jaw Associate Director Investor  Relations charlene.jaw@telixpharma.com

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You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

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©2026 Telix Pharmaceuticals Limited. All rights reserved.

[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.

[10] Frosina et al. Sci Rep. 2024.

[11] Goodenberger et al. Cancer Genetics. 2012.

[12] Smith et al. J Nucl Med. 2023.

[13] ClinicalTrials.gov ID: NCT05450744.

 

Source: Telix Pharmaceuticals Limited Related Stocks: ASX:TLX Australia:TLX Australia:TLX.AX NASDAQ:TLX