Telix today welcomes proposed changes announced by the Centers for Medicare & Medicaid Services (CMS) for the Hospital Outpatient Prospective Payment System (OPPS) rule to improve payments for diagnostic radiopharmaceuticals for Medicare patients in the United States (U.S.), facilitating continued patient access after transitional pass-through payment status expires.

Telix today announces that it has elected to withdraw its proposed initial public offering (IPO) in the United States.

Telix today announces that it has completed the submission of a Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for its investigational radiodiagnostic PET agent, TLX250-CDx (Zircaix®, 89Zr-DFO-girentuximab), for the characterisation of renal masses as clear cell renal cell carcinoma (ccRCC). 

Telix today announces additional positive data from the ProstACT SELECT trial (“SELECT”) of TLX591 (177Lu rosopatamab tetraxetan), a lutetium-labelled rADC therapy for the treatment of adult patients with PSMA-positive metastatic castrate-resistant prostate cancer (mCRPC). SELECT is a radiogenomics study intended to evaluate lesion concordance between 68Ga (gallium)-based PSMA-PET[4] imaging and TLX591 dosimetry for the purpose of validating PET imaging for patient selection for rADC therapy. The Company has previously reported final safety data from this study[3].

Telix today announces it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX007-CDx, a new and proprietary cold kit (“Kit”) for the preparation of PSMA-PET imaging for prostate cancer.  

Telix today announces the successful completion of CUPID, a first-in-human Phase I dose escalation study of TLX592 in patients with advanced prostate cancer.

Telix today announces the completion of the acquisition of QSAM Biosciences, Inc. (U.S. OTC: QSAM) and its lead investigational drug Samarium-153-DOTMP (153Sm-DOTMP). QSAM is a United States (U.S.) based company developing therapeutic radiopharmaceuticals for primary and metastatic bone cancer

Telix is pleased to provide notice that the Annual General Meeting of the Shareholders of Telix Pharmaceuticals Limited (ACN 616 620 369) will be convened on Wednesday 22 May 2024.

Telix today provides an update on its revenue and operational performance for the quarter ended 31 March 2024 (Q1 2024). 

Telix, today announces the completion of the acquisition of radioisotope production technology firm ARTMS Inc. (ARTMS), its advanced cyclotron-based isotope production platform, manufacturing plant and stockpile of ultra-pure rare metals required for consumable target production.