reports
CMS Grants Transitional Pass-Through Status for Gozellix
CMS Grants Transitional Pass-Through Status for Gozellix MELBOURNE, Australia and INDIANAPOLIS, Sept. 24, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that the United States (U.S.) Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s next-generation PSMA-PET1 imaging agent for prostate cancer. This designation enables separate reimbursement for Gozellix® under the Hospital Outpatient Pr...
Telix Doses First Patient in Phase 3 BiPASS Trial: PSMA-PET Imaging fo...
Telix Doses First Patient in Phase 3 BiPASS Trial: PSMA-PET Imaging for Prostate Cancer Diagnosis MELBOURNE, Australia and INDIANAPOLIS, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces it has dosed the first patient in a Phase 3 clinical trial aimed at expanding the indications for Illuccix® and Gozellix® (kits for the preparation of gallium-68 (68Ga) gozetotide injection) to include prostate cancer diagnosis. BiPASS™ (Biopsy of the Prostate Avoidance Stratification Study1) is the first registration-enabling study to eva...
Telix to Present at the Morgan Stanley 23rd Annual Global Healthcare C...
Telix to Present at the Morgan Stanley 23rd Annual Global Healthcare Conference and H.C. Wainwright 27th Annual Global Investment Conference MELBOURNE, Australia and INDIANAPOLIS, Aug. 26, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) will present at the Morgan Stanley 23rd Annual Global Healthcare Conference at 4:50 p.m. ET on Monday, September 8, 2025 (6:50 a.m. AEST, Sep 9) and at the H.C. Wainwright 27th Annual Global Investment Conference at 12:00 p.m. ET on Tuesday, September 9, 2025 (2:00 a.m. AEST, Sep 10). Dr. Christian Behrenbruch, Mana...
Telix 2025 Half-Year Results: Strong commercial performance enables in...
Telix 2025 Half-Year Results: Strong commercial performance enables investment for long-term growth MELBOURNE, Australia and INDIANAPOLIS, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces its financial results for the half-year ended 30 June 2025. All figures are in USD unless stated otherwise. H1 2025 key results1 Group performance2: Reflects strategic investment for long-term value creation Revenue of $390.4 million, up by 63%3 and on track to meet full year guidance4.Group gross profit margin of 53% reflects produ...
Telix H1 2025 Results: Investor Webcast Notification
Telix H1 2025 Results: Investor Webcast Notification MELBOURNE, Australia and INDIANAPOLIS, July 30, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today advises that it will release its financial results for the half-year ended 30 June 2025 on Thursday 21 August 2025. An investor webcast and conference call will be held at 9.30am AEST on Thursday 21 August 2025 (7.30pm EDT Wednesday 20 August 2025). Participants can register for the webcast at the following link: Participants can register for the teleconference here: About Telix Pharmaceu...
Telix Reports $204M Revenue, Up 63% YOY
Telix Reports $204M Revenue, Up 63% YOY MELBOURNE, Australia and INDIANAPOLIS, July 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today provides an update on its commercial and operational performance for the quarter ended 30 June 2025 (Q2 2025). All figures are in USD unless stated otherwise. Q2 2025 Highlights Q2 2025 unaudited group revenue of approximately $204 million, up 63% year-over-year.FY 2025 revenue guidance of $770 million to $800 million is reaffirmed.Gozellix® launched in the U.S. and commercial dose deliveries commenced....
Gozellix Receives Permanent HCPCS Code
Gozellix Receives Permanent HCPCS Code MELBOURNE, Australia and INDIANAPOLIS, July 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that its next-generation PSMA1 PET2 imaging agent, Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) code by the U.S. Centers for Medicare & Medicaid Services (CMS). Effective from 1 October 2025, CMS and commercial health insurers will recognise the HCPCS Level II code A9616 assigned for rei...
Illuccix Approved in U.S. for Patient Selection for Pre-Taxane RLT
Illuccix Approved in U.S. for Patient Selection for Pre-Taxane RLT 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 are indicated ...
Telix Precision Medicine Announces AlFluor Radiochemistry Platform
Telix Precision Medicine Announces AlFluor Radiochemistry Platform 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 development by Tel...
Telix Theranostic Programs and Satellite Symposia on Innovation in PSM...
Telix Theranostic Programs and Satellite Symposia on Innovation in PSMA and CAIX Imaging Featured at SNMMI 2025 MELBOURNE, Australia and INDIANAPOLIS, June 20, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces five abstract presentations and two satellite symposia featuring its developmental theranostic programs and commercial products at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2025 Annual Meeting being held in New Orleans, Louisiana (U.S.) from June 21 – 24. Presentation highlights include the Pro...
Telix Launches New Prostate Cancer Imaging Agent, Gozellix, in U.S.
Telix Launches New Prostate Cancer Imaging Agent, Gozellix, in U.S. MELBOURNE, Australia and INDIANAPOLIS, June 11, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces that its next-generation PSMA-PET imaging1 agent for prostate cancer, Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), is now commercially available nationally in the United States (U.S.). Gozellix is available through Telix’s comprehensive network of distribution partners, Cardinal Health, Inc., PharmaLogic Holdings Corp.,...
Telix Investor Day in New York City on June 11, 2025: Presenting KOLs
Telix Investor Day in New York City on June 11, 2025: Presenting KOLs MELBOURNE, Australia and INDIANAPOLIS, June 03, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) provides further details on the agenda for the Company’s Investor Day to be held on Wednesday, June 11, 2025, at The Yale Club in New York City, from 8.30am ET (10.30pm AEST) to 12.00pm ET. This education session will focus on the growth opportunities across Telix’s commercial and clinical portfolio of precision medicine and therapeutic radiopharmaceuticals. The followi...
Telix to Host Investor Day in New York City on June 11, 2025
Telix to Host Investor Day in New York City on June 11, 2025 MELBOURNE, Australia and INDIANAPOLIS, May 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces it will host an Investor Day on Wednesday, June 11, 2025, in person, in New York City, from 8:30am ET to 12.00pm ET. Institutional investors, analysts and company guests are cordially invited to attend the session, which will focus on the growth opportunities across Telix’s commercial and clinical portfolio of precision medicine and therapeutic radiopharmaceuticals...
Telix FAP-targeting Therapeutic Published in Thyroid Journal: Demonstr...
Telix FAP-targeting Therapeutic Published in Thyroid Journal: Demonstrates Encouraging Efficacy MELBOURNE, Australia and INDIANAPOLIS, May 08, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that its Fibroblast Activation Protein (FAP)-targeting therapy candidate, TLX400, has been published in Thyroid, the official journal of the American Thyroid Association. The candidate demonstrated an encouraging safety profile and efficacy in aggressive, radioiodine-resistant (RAI-R) thyroid cancer1. TLX400 (177Lu-DOTAGA.Glu.(FAPi)2)...
Telix's Illuccix PSMA-PET Imaging Agent Approved in France
Telix's Illuccix PSMA-PET Imaging Agent Approved in France New approval provides French hospitals and clinics with access to a proven PSMA-PET imaging agent MELBOURNE, 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 lesions in adults with ...
Telix Reports US$186M Q1 Revenue, Up 62% YOY
Telix Reports US$186M Q1 Revenue, Up 62% YOY MELBOURNE, Australia and INDIANAPOLIS, April 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today provides an update on its commercial and operational performance for the quarter ended 31 March 2025 (Q1 2025). All figures are in $US unless stated otherwise. Strong Q1 2025 revenue growth Q1 2025 unaudited revenue of approximately $186 million represents an increase of 62% over the prior year corresponding quarter (Q1 2024: $115M) and a quarter-over-quarter increase of 31% (Q4 202...
IPAX-Linz Study Reports Promising Efficacy for TLX101 Glioma Therapy C...
IPAX-Linz Study Reports Promising Efficacy for TLX101 Glioma Therapy Candidate MELBOURNE, Australia and INDIANAPOLIS, April 16, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces preliminary results from the Phase 2 IPAX-Linz study of TLX101 (131I-iodofalan1) in recurrent high-grade glioma (brain cancer), substantiating the patient benefit seen in the IPAX-1 study2. IPAX-Linz is a single-arm Phase 2 investigator-initiated trial (IIT). IPAX-Linz evaluates the safety, tolerability and preliminary efficacy of TLX101 therapy, in...
Telix Announces Cardinal Health for Gozellix Commercial Distribution
Telix Announces Cardinal Health for Gozellix Commercial Distribution MELBOURNE, Australia and INDIANAPOLIS, April 08, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that it has selected Cardinal Health, Inc. (NYSE: CAH, Cardinal Health) as one of its commercial radiopharmaceutical distributors to supply finished unit doses of Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s next-generation PSMA-PET imaging1 agent for prostate cancer in the United States (U.S.). Following recent...
Telix Appoints Paul Schaffer as Chief Technology Officer
Telix Appoints Paul Schaffer as Chief Technology Officer MELBOURNE, Australia and INDIANAPOLIS, April 07, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that is has appointed Dr. Paul Schaffer to the newly created role of Chief Technology Officer (CTO), effective today. Dr. Schaffer has been CTO at ARTMS Inc. (ARTMS) (acquired by Telix in 2024) for the past seven years, as well as Director, Life Science at TRIUMF, Canada’s particle accelerator research centre, since 2012. Based in Vancouver, Canada, Dr. Schaffer is widel...
Anne Whitaker Appointed as Non-Executive Director
Anne Whitaker Appointed as Non-Executive Director MELBOURNE, Australia and INDIANAPOLIS, April 04, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces the appointment of Anne Whitaker as a Non-Executive Director (NED) based in the United States, effective 7 April 20251. Ms. Whitaker is a seasoned healthcare leader and advisor with over 30 years’ global corporate experience spanning large pharmaceutical, biotech and speciality pharmaceutical companies, including clinical research and manufacturing organizations. She has held...
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