FDA Alignment to Advance ProstACT Global Phase 3 Trial

• FDA aligns with Telix on ProstACT Global Phase 3 trial advancement
• FDA approves clinical protocol and statistical framework
• Part 2 of the trial continues recruiting in approved jurisdictions

Telix Pharmaceuticals announced FDA alignment to advance the ProstACT Global Phase 3 trial for its therapeutic candidate TLX591-Tx in metastatic castration-resistant prostate cancer. The FDA confirmed the safety data from Part 1 and agreed on the clinical protocol and statistical framework for Part 2, which involves three standard-of-care combination cohorts. Part 2 is currently recruiting patients in regions with regulatory approval, including Australia, New Zealand, Canada, Türkiye, the United Kingdom, China, Singapore, and South Korea. The trial aims to enroll approximately 490 patients globally.