News & Views - Telix Pharmaceuticals Limited | Telix Pharmaceuticals Limited

Telix Granted FDA Fast Track Designation for BiPASS Pre-Biopsy Prostate Cancer Imaging

Telix today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s BiPASS® program, evaluating gallium-68 (68Ga) PSMA-PET imaging in combination with MRI for the detection of prostate cancer prior to biopsy.

Telix and ITM Join Forces to Create a Radiopharmaceutical Powerhouse

Telix today announces it has signed a strategic agreement to combine with ITM Isotope Technologies Munich SE (“ITM”), a global leader in radioisotope production and radiopharmaceutical development.

“Let’s go, let’s get them”

Michael Ramos served for 16 years as the elected District Attorney of San Bernardino County, California. In 2017, a year before he planned to retire, he was diagnosed with prostate cancer. We spoke with him about his diagnosis, the scan that changed the course of his care, and why he now brings a prosecutor’s energy to patient advocacy.

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.