Telix advances Phase 3 prostate trial after FDA alignment

• Telix (NASDAQ:TLX) said the U.S. FDA agreed that Phase 3 ProstACT Global Part 1 safety data support moving into Part 2.
• The FDA aligned on Part 2 design, including dosing of TLX591-Tx and combination use with standard prostate cancer therapies.
• U.S. trial continuation depends on an IND amendment review alongside a pending European regulatory submission.

Telix (NASDAQ:TLX) said the U.S. Food and Drug Administration agreed that safety data from Part 1 of its ProstACT Global Phase 3 trial support progression into Part 2 in the United States.

The decision relates to the company’s prostate cancer therapy TLX591-Tx, which is being evaluated in a two-dose regimen given 14 days apart alongside abiraterone, enzalutamide, or docetaxel.

The FDA aligned with Telix on the Part 2 protocol design, statistical approach, and safety monitoring framework for the next stage of the study.

Part 2 of the trial continues enrolling patients in regions where it has already received approval, while U.S. initiation remains pending review of an Investigational New Drug amendment.

The company said the regulatory pathway is also coordinated with a pending European submission linked to the same trial program.

Telix continues to develop its radiopharmaceutical pipeline focused on prostate cancer imaging and therapy applications.