News & Views

Telix today announces it has dosed the first patient in a Phase 3 clinical trial aimed at expanding the indications for Illuccix® and Gozellix® (kits for the preparation of gallium-68 (68Ga) gozetotide injection) to include prostate cancer diagnosis.

Telix today announces that it has reached agreement with the United States (U.S.) Food and Drug Administration (FDA) regarding resubmission of its New Drug Application (NDA) for TLX101-CDx (Floretyrosine F18 or 18F-FET, Pixclara®), an investigational agent for the imaging of glioma, a rare and life-threatening brain cancer. As previously advised, the Company confirms its plan to resubmit the NDA during Q4 2025.

Telix today announces that its prostate cancer PET imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in Spain by AEMPS for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. Illuccix® is now approved in all 19 countries included in Telix’s decentralized procedure (DCP) submitted in Europe.

Telix today advises that it will release its financial results for the half-year ended 30 June 2025 on Thursday 21 August 2025.

Telix today advises that it will release its financial results for the half-year ended 30 June 2025 on Thursday 21 August 2025.

Telix today provides an update on its commercial and operational performance for the quarter ended 30 June 2025 (Q2 2025). All figures are in USD unless stated otherwise.

Telix today announces that its prostate cancer PET imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by BASG for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enables healthcare providers in Austria to offer PSMA-PET imaging using a clinically validated gallium-based radiopharmaceutical.

Telix today announces that its next-generation PSMA PET imaging agent, Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) code by the U.S. Centers for Medicare & Medicaid Services (CMS).

Telix today announces that its Telix Manufacturing Solutions (TMS) facility in Brussels South (Seneffe), Belgium, has produced its first Good Manufacturing Practice (GMP)-grade commercial radiopharmaceutical doses and delivered them to the AIRC hospital collaboration in Charleroi, Belgium.

Telix today announces that its prostate cancer PET imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in Italy by the AIFA for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enables healthcare providers across Italy to offer PSMA-PET imaging using a clinically validated gallium-based radiopharmaceutical.