Q2 2024 Revenue and Business Highlights, Guidance Upgrade
Telix today provides an update on its revenue and operational performance for the quarter ended 30 June 2024 (Q2 2024).
Telix Welcomes CMS Proposal to Improve Payment for Specialised Diagnostic Radiopharmaceuticals
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 Elects to Withdraw from Proposed U.S. Listing
Telix today announces that it has elected to withdraw its proposed initial public offering (IPO) in the United States.
Telix Completes TLX250-CDx (Zircaix®) BLA Submission for Kidney Cancer Imaging
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 Announces Positive rPFS Data from ProstACT SELECT Trial of TLX591 rADC Therapy Candidate in Prostate Cancer
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 Highlights ProstACT GLOBAL and STARLITE-1 Therapy Studies in Prostate and Kidney Cancer at ASCO Annual Meeting 2024
Telix today announces two abstract presentations featuring the Company’s therapeutic radiopharmaceutical programs at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, Illinois from May 31 – June 4, 2024.
Telix Submits NDA for New Prostate Cancer Imaging Agent
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 Completes Proof-of-Concept Study of TLX592 Targeted Alpha Therapy in 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 Announces Abstract Presentations at BNMS Annual Spring Meeting
Telix today announces three abstract presentations featuring the Company’s theranostic programs at the British Nuclear Medicine Society (BNMS) Annual Spring Meeting being held in Belfast, Northern Ireland this week.
Telix and Cardinal Health Complete Global Clinical Supply Agreement for Actinium-225 for Targeted Alpha Therapy Pipeline Development
Telix today announces an agreement with Cardinal Health Nuclear & Precision Health Solutions (a subsidiary of Cardinal Health, Inc.) for the global clinical supply of actinium-225 (Ac-225), a therapeutic radioisotope that will be used in developing the Company’s targeted alpha therapy (TAT) pipeline.