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TLX News
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Telix Pharmaceuticals Doses First Patient with TLX250-Tx in LUTEON Study
Telix Pharmaceuticals announced that the first patient has been dosed with TLX250-Tx in the LUTEON study, the first radiopharmaceutical therapy to enter Phase 3 development for ccRCC. LUTEON is a randomized, prospective, open label, multi-center study evaluating a CAIX-targeting radionuclide therapy in patients with relapsed or recurrent ccRCC.
Telix Pharmaceuticals Doses First Patients in OPTIMAL-e Trial
Telix Pharmaceuticals announced that the first patients have been dosed with TLX597-Tx in the OPTIMAL-e trial, led by Professor Louise Emmett for patients with metastatic hormone-sensitive prostate cancer at St Vincent's Hospital in Sydney, Australia.
Telix Pharmaceuticals Successfully Advances TLX591-Tx Trial with FDA Meeting
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 Signs MOU with United Imaging for Strategic Collaboration
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.
Telix Pharmaceuticals Completes Patient Enrollment for TLX101-Tx Study
Telix Pharmaceuticals announces that the IPAX-2 study1 of TLX101-Tx in patients with newly diagnosed glioblastoma has completed patient enrolment. No dose-limiting toxicities have been observed to date, including with two doses of 5GBq, the maximum administered dose in the study.
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