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Telix Pharmaceuticals Limited (ASX:TLX)

ALERT: Price-sensitive ASX Announcement for TLX
Current share price for TLX : $17.380 5.65 (48.17%)+
Announcement
Release
17 Dec 2025 7:17PM
Price at Release
$11.730
Full Release
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Summary
Telix Pharmaceuticals Limited provided an update on the ProstACT Global Phase 3 study for their prostate cancer therapy, TLX591. The study, which is the first Phase 3 trial to combine a PSMA-targeted radio antibody-drug conjugate with standard of care treatments, has completed enrolment for Part 1 and is progressing to Part 2 following a recommendation from the Independent Data Monitoring Committee. Part 2 has started dosing in several countries, and Telix plans further expansions. TLX591 has shown a favorable safety profile compared to other therapies, with no significant kidney toxicity due to its liver clearance.
Key Points
  • Telix confirms completion of patient enrolment into Part 1 of ProstACT Global study.
  • Part 1 data will be presented to the FDA for Part 2 eligibility.
  • Independent Data Monitoring Committee recommended proceeding to Part 2.
  • Part 2 dosing initiated in Australia, New Zealand, Canada, and approved in several other countries.
  • TLX591 demonstrates different targeting with limited kidney toxicity, cleared through the liver.
  • Telix plans to file a clinical trial application with the European Medicines Agency for further expansion.
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.