Telix today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for its investigational positron emission tomography (PET) imaging agent TLX250-CDx (Zircaix™, 89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC).

Telix Group Chief Medical Officer, Dr Colin Hayward, moderated an expert discussion with global key opinion leaders on the evolving treatment landscape for PSMA-targeted radiopharmaceuticals, including Telix’s first-in-class investigational radio-antibody drug conjugate (rADC), TLX591 (177Lu-rosopatamab tetraxetan).

Telix today advises it will host an investor webcast on Tuesday, 21 November 2023, from 10.15am – 11.15am AEDT (12:15am CET / 6.15pm EST, 20 November). Telix Group Chief Medical Officer, Dr Colin Hayward, will moderate an expert discussion with global key opinion leaders listed below on the evolving treatment landscape for PSMA-targeted radiopharmaceuticals, including Telix’s first-in-class investigational radio-antibody drug conjugate (rADC), TLX591 (177Lu-rosopatamab tetraxetan).

Telix today announces it has signed a conditional Term Sheet to acquire QSAM Biosciences, Inc. (QSAM) and its lead asset, CycloSam® (Samarium-153-DOTMP). QSAM is a United States (U.S.) based clinical stage company developing therapeutic radiopharmaceuticals for primary and metastatic bone cancer.

Telix and Paris-based Mauna Kea Technologies, today announce an expansion of the IRiS (Imaging and Robotics in Surgery) Alliance through a strategic €6.0 million (AU$9.6 million) investment to develop new hybrid pharmaceutical-device products through the combination of Telix’s cancer-targeting agents with Mauna Kea’s Cellvizio® surgical endomicroscopy platform. Telix’s investment in Mauna Kea will further support the development of advanced imaging techniques for minimally invasive (laparoscopic and robotic) surgery, with a specific focus on urologic oncology.

Telix today announces that the first patient has been dosed in the Company’s Phase III ProstACT GLOBAL study of its investigational prostate-specific membrane antigen (PSMA) targeting radio-antibody drug conjugate (rADC) therapy, TLX591 (177Lu-rosopatamab tetraxetan). TLX591 is a rADC composed of a high-specificity PSMA-targeting antibody, chelator linker, and cytotoxic lutetium (177Lu) payload. The PSMA-targeted monoclonal antibody (mAb) approach offers significantly different targeting and pharmacology to anti-PSMA small molecules.

Telix today announces it has signed an exclusive agreement with Denmark-based WIIK Pharma ApS (Wiik Pharma) for the distribution of Telix’s investigational prostate cancer imaging agent, Illuccix® (TLX591-CDx, Kit for the preparation of 68Ga-PSMA-11 injection) in the Nordic region.

Telix, today announces the completion of the acquisition of Lightpoint Medical and its SENSEI® radio-guided surgery business (refer to announcement on 21 June 2023).

Telix today announces positive preliminary results from the Phase I ProstACT SELECT study of its rADC therapy candidate TLX591 (Lutetium (177Lu) rosopatamab tetraxetan) for prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC).

Telix today issues its Appendix 4C quarterly cash flow report and accompanying Activities Report for the quarter ended 30 September 2023 (Q3 2023). All figures are in AUD$ unless otherwise stated and provided on an unaudited basis.