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TLX-News
TLX-Events
Telix Pharmaceuticals Completes Patient Enrollment in BiPASS Study
Telix Pharmaceuticals announced completion of patient enrollment in the Phase 3 BiPASS study of its commercial PSMA-PET1 imaging agents, Illuccix and Gozellix for prostate cancer imaging in the pre-biopsy setting. Telix has also aligned with the United States Food and Drug Administration on a New Drug Application (NDA) pathway for BiPASS that, if approved, would support reimbursement as a new product and broaden patient access. BiPASS is the first registrational study of 68Ga-PSMA-PET imaging in the pre-biopsy setting. The study aims to evaluate whether the combination of MRI3 and PSMA-PET/CT4 with Telix's proprietary 68Ga-PSMA-PET agents can further improve diagnostic accuracy, reduce unnecessary biopsies, or improve targeting of biopsy compared with current standard practice. A total of 350 patients were enrolled in the U.S. and Australia in this prospective, open-label Phase 3 trial.
Telix Pharmaceuticals Appoints David Gill as Chair of the Board
Telix Pharmaceuticals (TLX) announced that David Gill has been appointed Chair of the Board, effective immediately. Gill joined Telix as a Non-Executive Director in May 2026 as part of the Company's Board expansion and succession planning1, with the intention that he would be appointed Chair in due course. He succeeds Dr. Mark Nelson, who has served as interim Chair and will remain on the Board as a Non-Executive Director. Gill is a life sciences executive with over 35 years' experience in senior general management and financial leadership roles across commercial and clinical-stage biopharmaceutical (including radiopharmaceutical development, manufacturing and supply chain) and medical device companies. He currently serves on the boards of Evolus, Inc. (EOLS), Allucent LLC, Bridge to Life Ltd, RapidPulse Inc., and huMannity Medtec.
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.
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