Telix Submits European Marketing Authorization Application for TLX101-Px for Brain Cancer Imaging
MELBOURNE, Australia and INDIANAPOLIS, Feb. 18, 2026 (GLOBE NEWSWIRE) -- 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-[
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
In Europe, positron emission tomography (PET) imaging of glioma with
Philipp Lohmann, Group Leader Digital Translational Neuroimaging 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
Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, added, “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.”
About glioma in Europe
In Europe, approximately 67,500 brain and central nervous system tumors are diagnosed every year
About TLX101-Px
TLX101-Px (O-(2-[
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. 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 developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).
Telix Investor Relations (Global)
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: [email protected]
This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
Legal Notices
Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.
You may also like
The co-branded card approval stalemate awaits a breakthrough: JPMorgan Chase (JPM.US) reportedly plans a "second review" scheme, intending to introduce private credit to handle rejected applications.
J.P. Morgan has recently studied a plan aimed at resolving long-standing conflicts with its co-branded credit card partners, such as airlines and retailers. If this plan is implemented, private credit funds will gain new opportunities to enter the consumer credit sector.
AI agents ignite a frenzy for Mac! Apple (AAPL.US) joins the battle for AI computing power budget, advancing into the AI infrastructure sector
Apple has launched new Mac computers, aiming to compete with Microsoft and Nvidia, and striving to significantly reduce the cost of AI computing resources.
Has the poor performance of new stocks in the same track dampened subscription enthusiasm? Bamboo makes an emergency halt the night before pricing, doubling its valuation in a year but struggling to find a "buyer".
Bamboo, the master underwriter for homeowners insurance in California and Texas, postponed its IPO on Tuesday. The company had planned to issue 35 million existing shares at $18–$20 per share to raise $665 million.

Is the AI replacement wave overestimated? Barclays: Only 20% of core workplace skills can be highly replicated, but amplification effects are quietly spreading
The impact of AI on the workforce is milder, yet more profound than previously imagined. Barclays' latest research dispels the panic of a "replacement wave"—only about 20% of core professional skills can truly be replicated by AI, but its "amplification effect" permeates almost every corner of every profession. What is more concerning is that the demand for AI skills is spreading from tech positions to management roles, and the rise of physical AI could even make human professional skills a new, scalable form of intellectual property.
