News & Views - Telix Pharmaceuticals Limited | Telix Pharmaceuticals Limited

FDA Approves Telix’s Brain Cancer Imaging Drug Pixclara

Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Pixclara® (floretyrosine F 18 or 18F-FET), an amino acid positron emission tomography (PET) drug for imaging gliomas (brain cancer).

Reliable access and availability of Ga-68 radiopharmaceuticals

There when you need it: we asked five leaders across the nuclear medicine industry to share their specific experiences with one of the four key advantages of Gallium-68* (Ga-68) PET imaging: availability and reliable access on demand.

Telix to Present at the Morgan Stanley 24th Annual Global Healthcare Conference and H.C. Wainwright 28th Annual Global Investment Conference

Telix advises that Dr. Christian Behrenbruch, Managing Director and Group CEO and Kevin Richardson, CEO, Precision Medicine will present at the upcoming Morgan Stanley 24th Annual Global Healthcare Conference and at the H.C. Wainwright 28th Annual Global Investment Conference, both in New York, NY.

Telix Completes Enrollment in Phase 3 BiPASS Study, Aligns with FDA on NDA Pathway

Telix today announced completion of patient enrollment in the Phase 3 BiPASS™ study of its commercial PSMA-PET[1] imaging agents, Illuccix® (kit for the preparation of gallium Ga68 gozetotide injection) and Gozellix® (kit for the preparation of gallium Ga68 gozetotide injection) for prostate cancer imaging in the pre-biopsy setting. Telix has also aligned with the United States (U.S.) Food and Drug Administration (FDA) on a New Drug Application (NDA) pathway for BiPASS that, if approved, would support reimbursement as a new product and broaden patient access.

Telix Appoints David Gill as Chair

Telix today announces that David Gill has been appointed Chair of the Board, effective immediately.

Telix 2026 Half-Year Results: Strong Commercial Execution and Momentum in Late-Stage Pipeline

Telix today announces its financial results for the period ended June 30, 2026.

Telix to Host R&D Day in New York City

Telix today advises that it will host a Research and Development (R&D) Day on Tuesday, September 22, 2026, from 8:30 a.m. to 12:30 p.m. EDT in New York City.

Telix H1 2026 Results: Investor Webcast Notification

Telix today advises that it will release its financial results for the half-year ended June 30, 2026 on Thursday August 20, 2026.

EJNMMI Research: TLX400-Tx Shows Encouraging Disease Control in Medullary Thyroid Cancer

Telix today announces publication of long‑term clinical outcomes from an investigator‑led study evaluating TLX400‑Tx, its lead fibroblast activation protein (FAP)-targeted therapy candidate, in patients with advanced or metastatic medullary thyroid carcinoma (MTC).

TLX591-Tx ProstACT SELECT Study Published in Cancers Journal

Telix today announced publication of results from the ProstACT SELECT study in Cancers, a peer-reviewed journal. The Phase 1 study evaluated TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan), Telix’s first-in-class prostate-specific membrane antigen (PSMA) targeting radio antibody-drug conjugate (rADC) therapy candidate. The study’s scientific purpose was to evaluate lesion concordance between 68Ga-PSMA-PET[5] and multi-time point SPECT[6] imaging for patient selection using a “theranostic” approach.