News & Views - Telix Pharmaceuticals Limited | Telix Pharmaceuticals Limited

Telix Completes Enrollment in Phase 3 BiPASS Study, Aligns with FDA on NDA Pathway

Telix today announced completion of patient enrollment in the Phase 3 BiPASS™ study of its commercial PSMA-PET[1] imaging agents, Illuccix® (kit for the preparation of gallium Ga68 gozetotide injection) and Gozellix® (kit for the preparation of gallium Ga68 gozetotide injection) for prostate cancer imaging in the pre-biopsy setting. Telix has also aligned with the United States (U.S.) Food and Drug Administration (FDA) on a New Drug Application (NDA) pathway for BiPASS that, if approved, would support reimbursement as a new product and broaden patient access.

EJNMMI Research: TLX400-Tx Shows Encouraging Disease Control in Medullary Thyroid Cancer

Telix today announces publication of long‑term clinical outcomes from an investigator‑led study evaluating TLX400‑Tx, its lead fibroblast activation protein (FAP)-targeted therapy candidate, in patients with advanced or metastatic medullary thyroid carcinoma (MTC).

TLX591-Tx ProstACT SELECT Study Published in Cancers Journal

Telix today announced publication of results from the ProstACT SELECT study in Cancers, a peer-reviewed journal. The Phase 1 study evaluated TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan), Telix’s first-in-class prostate-specific membrane antigen (PSMA) targeting radio antibody-drug conjugate (rADC) therapy candidate. The study’s scientific purpose was to evaluate lesion concordance between 68Ga-PSMA-PET[5] and multi-time point SPECT[6] imaging for patient selection using a “theranostic” approach.

PSMA-PET imaging for prostate cancer: Exploring gallium-68 in clinical practice

Telix spoke with a panel of global experts to examine the rapid evolution of gallium-68 (68Ga) PSMA-PET imaging in prostate cancer and to ask where the technology goes next.

Telix Doses First Patient in Phase 3 LUTEON Trial of TLX250-Txfor Renal Cancer

Telix today announced that the first patient has been dosed with TLX250-Tx (lutetium-177 (177Lu) girentuximab tetraxetan)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 Completes Patient Enrollment in TLX591-Px (Illuccix®) Japan Phase 3 Study

Telix today announced completion of patient enrollment in the pivotal Phase 3 registration study of TLX591-Px (Illuccix®, Kit for the preparation of 68Ga-PSMA-11[1]) for prostate cancer imaging in Japanese patients.

ProstACT Global Phase 3 (Part 1) Data Presented in Late-Breaking Oral Session at ASCO 2026

Telix announces the oral presentation of Part 1 safety, dosimetry and pharmacokinetics data from the ProstACT Global Phase 3 Study of TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan), in metastatic castration-resistant prostate cancer (mCRPC). The late-breaking data were presented today at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois by study Principal Investigator Pedro C. Barata, MD, Medical Oncologist, University Hospitals Seidman Cancer Center and Associate Professor of Medicine, Case Western Reserve University of School of Medicine, Cleveland, Ohio.

OPTIMAL-PSMA Trial of TLX597-Tx Next Generation RLT Presented at IPCS 2026 Highlighting Therapeutic Potential in Prostate Cancer

Telix today announces dosimetry results from the randomized Phase 2 OPTIMAL-PSMA trial of TLX597-Tx in metastatic castration-resistant prostate cancer (mCRPC), presented at the 2026 International Prostate Cancer Symposium (IPCS 2026) held in Lugano, Switzerland. These findings support TLX597-Tx’s potential to deliver a treatment that overcomes quality-of-life challenges that currently limit the clinical utility of existing RLTs in earlier-stage metastatic prostate cancer.

ProstACT Global Phase 3 (Part 1) Selected as Late-Breaking Abstract at ASCO 2026

Telix today announces that safety and tolerability data from the ProstACT Global Phase 3 study (Part 1) will be presented as a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, IL.

ProstACT Global Phase 3 Study (Part 1) Achieves Primary Objectives

Telix today announces that Part 1 of the ProstACT Global Phase 3 study, the safety and dosimetry lead-in for its therapeutic candidate – TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) – has achieved its primary objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed.