News & Views | Telix Pharmaceuticals Limited

Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate

Telix today announces the resubmission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-Px, (Pixclara®, Floretyrosine F 18 or 18F-FET), an investigational PET imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients.

ProstACT Global Phase 3 Study (Part 1) Achieves Primary Objectives

Telix today announces that Part 1 of the ProstACT Global Phase 3 study, the safety and dosimetry lead-in for its therapeutic candidate – TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) – has achieved its primary objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed.

FY 2025 Results: Strong Commercial Growth, Focused Pipeline Investment

Telix today announces its financial results for the year ended December 31, 2025.

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

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 Full Year Results 2025 Investor Webcast Notification

Telix advises that it will release its full year results for the period ended 31 December 2025 on Friday 20 February 2026 AEDT (Thursday 19 February 2026 EST).

Telix Achieves FY 2025 Guidance with US$804M (A$1.2B) Revenue, Accelerates Growth with Gozellix Launch

Telix provides an update on its commercial and operational performance for the quarter ended 31 December 2025 (Q4 2025).

Presentation to J.P. Morgan Healthcare Conference

Telix is pleased to provide a copy of the presentation that will be delivered by Dr. Christian Behrenbruch, Managing Director and Group CEO at the 44th Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA (U.S.).

ZIRDOSE-CP Study of TLX250-CDx published in EJNMMI Research: Confirms Favorable Safety and Tolerability Profile in Chinese patients

Telix today announces that final results from the ZIRDOSE-CP Phase 1 study of TLX250-CDx (Zircaix®, 89Zr-girentuximab) PET imaging in Chinese patients with suspected clear cell renal cell carcinoma (ccRCC) have been published in the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) Research.

Telix to Present Pipeline and Commercial Portfolio Overview at J.P. Morgan Healthcare Conference

Telix today advises that Dr. Christian Behrenbruch, Managing Director and Group CEO, will be presenting at the 44th Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA (U.S.).

Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX101-CDx and TLX250-CDx FDA Resubmissions

Telix today provides a precision medicine portfolio update in relation to