Telix gets FDA Fast Track for BiPASS pre-biopsy prostate imaging program
The designation applies to Telix's 68Ga-PSMA-PET imaging combined with MRI for detecting prostate cancer before biopsy, announced September 30, 2026.
SEC filing
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Tuesday, September 29
Monday, September 21
Telix Pharmaceuticals to merge with ITM Isotope Technologies Munich in radiopharma deal
Telix will pay ITM shareholders $1.65 billion upfront and up to $700 million more tied to regulatory and sales milestones for cancer drug candidate ITM-11.
SEC filing
Monday, September 14
FDA approves Telix's Pixclara for glioma imaging
The agency cleared the first FET-PET imaging drug for brain cancer, allowing use in adults and pediatric patients as young as 1 month old.
SEC filing
Tuesday, September 1
Telix finishes enrollment in Phase 3 BiPASS trial, aligns with FDA on NDA path
Telix Pharmaceuticals completed enrollment of 350 patients in its Phase 3 BiPASS study of Illuccix and Gozellix and reached agreement with the FDA on a New Drug Application route for pre-biopsy imaging use.
SEC filing
Monday, August 31
Telix Pharmaceuticals names David Gill as Board Chair
Gill succeeds Dr. Mark Nelson, who had served as interim Chair and will stay on the board as a Non-Executive Director.
SEC filing
Wednesday, August 19
Telix reports 22% H1 2026 revenue growth, guides to upper end of FY targets
Telix posted $477M in first-half revenue and net profit of $38M, while advancing five late-stage clinical programs and a Regeneron collaboration.
SEC filing