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Telix Pharmaceuticals Limited (ASX:TLX)

ALERT: Price-sensitive ASX Announcement for TLX
Current share price for TLX : $16.940 -0.12 (-0.70%)+
Announcement
Release
2 Jul 2026 10:07AM
Price at Release
$17.060
Full Release
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Summary
Telix Pharmaceuticals Limited has announced its successful alignment with the U.S. Food and Drug Administration (FDA) regarding the advancement of Part 2 of the ProstACT Global Phase 3 trial for TLX591-Tx in metastatic castration-resistant prostate cancer. This decision follows a Type B meeting with the FDA, where the clinical trial protocol and statistical framework were agreed upon. The trial, which aims to enhance the integration of radiopharmaceutical therapy into existing treatment regimens, is recruiting patients internationally in approved regions and seeks to enroll approximately 490 patients. Telix, headquartered in Melbourne, is a global leader in radiopharmaceuticals, focusing on improving cancer treatment outcomes through targeted theranostics.
Key Points
  • FDA and Telix align on advancement into Part 2 of the ProstACT Global Phase 3 trial in the U.S.
  • FDA agrees with the clinical protocol and proposed statistical framework for the trial.
  • Part 2 of the trial continues to recruit patients internationally where approved.
  • The trial aims to redefine the integration of radiopharmaceutical therapy in clinical practice.
  • ProstACT Global Phase 3 includes a multicenter trial targeting around 490 patients.
  • Telix Pharmaceuticals is a global radiopharmaceutical company focused on cancer theranostics.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.