Core Insights - Telix Pharmaceuticals has received a permanent HCPCS code for its next-generation PSMA PET imaging agent, Gozellix, which will enhance billing and reimbursement processes in the U.S. healthcare system [1][2][4] Group 1: Product Development and Approval - Gozellix is indicated for PET scanning of PSMA positive lesions in men with prostate cancer, particularly those with suspected metastasis or biochemical recurrence [3] - The product features an extended shelf-life and flexible production options, addressing logistical barriers to PSMA-PET imaging access [3][4] - Gozellix has been approved by the U.S. FDA, following the success of Telix's first-generation PSMA-PET imaging agent, Illuccix [5] Group 2: Market Impact and Future Prospects - The HCPCS code assignment is a significant milestone that supports clinical adoption and reimbursement for Gozellix, facilitating its commercial scale-up in the U.S. [2][4] - The CEO of Telix emphasized that this development is crucial for improving access to precision medicine imaging for prostate cancer patients across the U.S. [4] Group 3: Company Overview - Telix Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals [4] - The company operates internationally, with a presence in the U.S., Brazil, Canada, Europe, and Japan, aiming to address unmet medical needs in oncology and rare diseases [4]

MELBOURNE, Australia and INDIANAPOLIS, June 23, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved a label expansion for Illuccix® (kit for the preparation of gallium Ga-68 gozetotide, for injection) to include patient selection for radioligand therapy (RLT) in the pre-taxane setting. The update applies to Illuccix’s third indication, for selection of patients who ...

MELBOURNE, Australia and INDIANAPOLIS, June 20, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces it has launched a novel PET1 radiochemistry solution based on 18F-aluminium fluoride (AlF), named AlFluor™. The AlFluor™ platform technology enables flexible radiolabeling of PSMA2 with either AlF or gallium-68 (68Ga). It also has the potential to be used with ligands targeting NETs3 and FAP4, as well as other novel imaging agents under devel ...

Core Insights - The recent announcement of former US President Biden's prostate cancer diagnosis has brought attention to prostate cancer, the second most common malignancy among men globally [2] - The incidence and mortality rates of prostate cancer in China are rising, with 134,200 new cases and 47,500 deaths reported in 2022 [2] - The treatment landscape for prostate cancer is evolving, with numerous innovative pharmaceutical companies developing new therapies, enhancing treatment options for patients [2][4] Market Dynamics - The global prostate cancer treatment market was valued at $35.3 billion in 2022 and is projected to grow to $56.4 billion by 2028, with a compound annual growth rate (CAGR) of 8.3% [4] - Major pharmaceutical companies are competing in this lucrative market, with Pfizer and Astellas' enzalutamide generating $5.926 billion in global sales in 2023, ranking sixth among oncology drugs [3][4] - Chinese pharmaceutical companies are transitioning from generic to innovative drug development, with Heng Rui Medicine's new drug, Rivelutamide, set to launch in December 2024 [4] Treatment Advances - Treatment options for prostate cancer have expanded significantly, with survival rates improving from 2-3 years to over 5 years due to advancements in therapies such as new anti-androgens and PARP inhibitors [3] - The introduction of targeted therapies, such as Novartis' Pluvicto, which achieved $271 million in its first year, indicates a shift towards precision medicine in prostate cancer treatment [3][4] Screening Challenges - Early detection of prostate cancer remains a challenge, with many patients diagnosed at advanced stages due to the disease's asymptomatic nature in early stages [5][6] - The five-year survival rate for prostate cancer patients in China is approximately 66.4%, significantly lower than over 95% in developed countries, highlighting the need for improved screening practices [5] - PSA testing is the primary screening method, and initiatives are underway to increase screening coverage in China, aiming for 40% coverage in the next five years [7]

New approval provides French hospitals and clinics with access to a proven PSMA-PET imaging agentMELBOURNE, Australia, April 29, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that its prostate cancer PET1 imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in France by ANSM2 for the detection and localization of prostate-specific membrane antigen (PSMA)-positive le ...