TLX News & Events

Telix Pharmaceuticals announced the successful outcome of a Type B meeting with the FDA to review the Part 1 safety and dosimetry data and Part 2 protocol design of the ProstACT Global Phase 3 trial of its therapeutic candidate TLX591-Tx in metastatic castration resistant prostate cancer. The FDA has confirmed that the safety data from Part 1 of the study is sufficient to enable progression of Part 2 of ProstACT Global into the U.S. in which TLX591-Tx is administered in two doses, 14 days apart, in combination with one of three randomized standard of care therapies: abiraterone, enzalutamide or docetaxel. The FDA and Telix also achieved alignment on the Part 2 clinical trial protocol, statistical analysis plan, and ongoing safety monitoring plan. The result is a consistent framework for study execution as enrollment continues internationally and expands into the U.S. Initiation of Part 2 in the U.S. remains subject to the FDA's review of an investigational new drug, or IND, amendment. The IND amendment will also be aligned with a pending regulatory submission to initiate the ProstACT Global study in Europe. The trial continues to enroll patients in regions where Part 2 is approved.

Telix Pharmaceuticals announced the signing of a memorandum of understanding, or MOU, to evaluate a strategic research collaboration in the United States focused on advancing integrated theranostics solutions. The companies will evaluate the combination of United Imaging's scanner platforms, software, connectivity and AI capabilities with Telix's molecular imaging portfolio and validated clinical protocols. The collaboration will explore how a unified approach can drive theranostic workflow efficiencies and standardization. The collaboration will initially focus on TLX101-Px in the U.S, with potential expansion into additional markets, and other Telix products and product candidates, subject to mutual agreement. Early efforts will include scanning protocol optimization, workflow support tools development and validation, and launching pilot programs aligned with high-impact clinical applications.