Telix Submits European Marketing Authorization Application for TLX101-Px for Brain Cancer Imaging
Telix Pharmaceuticals Limited - American Depositary Shares (TLX)
Company Research
Source: GlobeNewswire
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-[18F]fluoroethyl)-L-tyrosine, 18F-FET), its glioma (brain cancer) imaging candidate. 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 markets1. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines2. Submission of the U.S. New Drug Application (NDA) will follow. In Europe, positron emission tomography (PET) imaging of glioma with 18F-FET (FET-PET) is currently performed u
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News
- Telix Pharmaceuticals Highlights $1B Revenue Track, Pixclara Resubmission, PSMA Growth at Oppenheimer Conf. [Yahoo! Finance]Yahoo! Finance
- Investor Education WebinarGlobeNewswire
- Investor Education WebinarPR Newswire
- Telix Joins Forces with University Hospital Essen on PROMISE-PET: Optimizing Patient Management through AI-enabled PSMA-PET ImagingGlobeNewswire
- 1 Basically Unknown Stock That Could Turn Cancer-Imaging Breakthroughs Into Generational Wealth [Yahoo! Finance]Yahoo! Finance
TLX
Sec Filings
- 2/20/26 - Form F-3ASR
- 2/20/26 - Form 20-F
- 2/19/26 - Form 6-K
- TLX's page on the SEC website