Expanded Access Program Opens in the U.S. for TLX101-CDx, Telix’s Investigational Glioma (Brain Cancer) Imaging Agent
Telix today announces the opening of an expanded access program (EAP) in the United States (U.S.) for TLX101-CDx (Pixclara®1, 18F-floretyrosine or 18F-FET) an investigational positron emission tomography (PET) agent for imaging progressive or recurrent glioma, following U.S. Food and Drug Administration (FDA) agreement to proceed.
Telix has released an update to its Modern Slavery Statement
Modern slavery is a grave human rights violation involving various forms of exploitation, such as forced labour, human trafficking, debt bondage, forced marriage, and child exploitation. It affects millions globally, with recent estimates suggesting over 40 million people are trapped in modern slavery.
FDA Accepts Telix NDA for New Prostate Cancer Imaging Agent
Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for TLX007-CDx, a new and proprietary cold kit (“Kit”) for the preparation of PSMA-PET imaging1 for prostate cancer. The PDUFA2 goal date is March 24, 2025.
Telix Successfully Prices A$650 Million Convertible Bonds
Telix is pleased to announce that it has successfully priced A$650 million 2.375 per cent convertible notes due 2029. The convertible notes, also referred to as “convertible bonds” (Convertible Bonds), are convertible into fully paid ordinary shares in Telix (Ordinary Shares). The Offering received strong support from eligible investors globally.
Telix Announces A$600 Million Convertible Bonds Offering
Telix today launches an offering of A$600 million of convertible notes due 2029 (the Offering). The convertible notes, also referred to as “convertible bonds” (Convertible Bonds), are convertible into fully paid ordinary shares in Telix (Ordinary Shares).
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 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).