reports
Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer...
Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate MELBOURNE, Australia and INDIANAPOLIS, March 16, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces the resubmission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-Px, (Pixclara®1, Floretyrosine F 18 or 18F-FET), an investigational PET2 imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients....
ProstACT Global Phase 3 Study (Part 1) Achieves Primary Objectives
ProstACT Global Phase 3 Study (Part 1) Achieves Primary Objectives Webcast and conference call to be held today, Tuesday March 10 at 9:30 a.m. AEDT (Monday March 9 at 6:30 p.m. EDT). Investors can register at the following link: MELBOURNE, Australia and INDIANAPOLIS, March 10, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that Part 1 of the ProstACT Global Phase 3 study, the safety and dosimetry lead-in for its therapeutic candidate – TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) – has achieved its primary objectives, ...
Investor Education Webinar
Investor Education Webinar The Future of Prostate Imaging: What do physicians want? MELBOURNE, Australia and INDIANAPOLIS, March 02, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) invites investors to join a webinar with key opinion leaders to discuss a physician’s perspective on innovations in PSMA-PET/CT imaging for prostate cancer. Speakers: Rodney Hicks, MD, Professor of Medicine at the University of Melbourne and Monash University; Founder, Executive Chairman and Chief Medical Officer at the Melbourne Theranostic Innovation Centre (MTIC);P...
Telix Joins Forces with University Hospital Essen on PROMISE-PET: Opti...
Telix Joins Forces with University Hospital Essen on PROMISE-PET: Optimizing Patient Management through AI-enabled PSMA-PET Imaging MELBOURNE, Australia and INDIANAPOLIS, Feb. 27, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces a research collaboration with University Hospital Essen on the PROMISE-PET registry1, defining the potential prognostic value of PSMA-PET2 imaging through artificial intelligence (AI). PROMISE (PROstate cancer Molecular Imaging Standardized Evaluation)-PET is a multi-center, prospective, observational, non-in...
Telix to Participate in Oppenheimer and TD Cowen Conferences
Telix to Participate in Oppenheimer and TD Cowen Conferences MELBOURNE, Australia and INDIANAPOLIS, Feb. 20, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) will participate in the upcoming Oppenheimer 36th Annual Healthcare Life Sciences Conference (virtual) and in the TD Cowen 46th Annual Health Care Conference in Boston, MA (U.S.). Managing Director and Group CEO, Dr. Christian Behrenbruch, will take part in a fireside chat with Oppenheimer on Thursday, February 26, 2026 at 4:40 p.m. EST (Friday, Feb 27 at 8:40 a.m. AEDT). Kevin Richardson, Chi...
FY 2025 Results: Strong Commercial Growth, Focused Pipeline Investment
FY 2025 Results: Strong Commercial Growth, Focused Pipeline Investment MELBOURNE, Australia and INDIANAPOLIS, Feb. 20, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces its financial results for the year ended December 31, 2025. FY 2025 key results1 Group performance2: Double-digit revenue growth and positive adjusted operating cash flow Revenue of US$803.8 million, up by 56%3 and achieving upsized full year guidance4.US$157.1 million invested in research and development (R&D) product development for late-stage therapeutics and prec...
Telix Submits European Marketing Authorization Application for TLX101-...
Telix Submits European Marketing Authorization Application for TLX101-Px for Brain Cancer Imaging MELBOURNE, Australia and INDIANAPOLIS, Feb. 18, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that it has submitted a marketing authorization application (MAA) in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, 18F-FET), its glioma (brain cancer) imaging candidate. Telix has been preparing the European and U.S. regulatory packages for TLX101-Px concurrently, bringing forward the European submission to meet an agreed filing da...
Telix Full Year Results 2025 Investor Webcast Notification
Telix Full Year Results 2025 Investor Webcast Notification MELBOURNE, Australia and INDIANAPOLIS, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) advises that it will release its full year results for the period ended 31 December 2025 on Friday, 20 February 2026 AEDT (Thursday, 19 February 2026 EST). An investor webcast and conference call will be held at 9:30 a.m. AEDT, Friday, 20 February 2026 (5:30 p.m. EST, Thursday, 19 February 2026). Participants can register at the following link: About Telix Pharmaceuticals Limited Telix is a ...
Telix Achieves FY 2025 Guidance with US$804M (A$1.2B) Revenue, Acceler...
Telix Achieves FY 2025 Guidance with US$804M (A$1.2B) Revenue, Accelerates Growth with Gozellix Launch MELBOURNE, Australia and INDIANAPOLIS, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) provides an update on its commercial and operational performance for the quarter ended 31 December 2025 (Q4 2025). Q4 2025 Highlights Full-year (FY) 2025 unaudited Group revenue of approximately US$804 million (A$1.2 billion1), in line with upgraded guidance of US$800-$820 million2 (previously US$770-800 million).Q4 2025 unaudited Group revenue of app...
First U.S. Patient Dosed in BiPASS: Phase 3 Prostate Cancer Diagnosis ...
First U.S. Patient Dosed in BiPASS: Phase 3 Prostate Cancer Diagnosis Study MELBOURNE, Australia, Jan. 17, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that the first patient in the United States (U.S.) has been dosed in BiPASS™ (Biopsy of the Prostate Avoidance Stratification Study), a Phase 3 trial to evaluate the use of Telix’s commercial PSMA-PET1 imaging agents, Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) and Gozellix® (kit for the preparation of gallium Ga 68 gozetotide injection) in the initial...
Telix to Present Pipeline and Commercial Portfolio Overview at J.P. Mo...
Telix to Present Pipeline and Commercial Portfolio Overview at J.P. Morgan Healthcare Conference MELBOURNE, Australia and INDIANAPOLIS, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today advises that Dr. Christian Behrenbruch, Managing Director and Group CEO, will be presenting at the 44th Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA (U.S.). Telix will host a presentation on Monday, 12 January at 9:00 am PST (12:00 pm EST / 4:00 am AEDT, 13 January), providing an overview of the Company’s pipeline assets alo...
Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX...
Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX101-CDx and TLX250-CDx FDA Resubmissions MELBOURNE, Australia and INDIANAPOLIS, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today provides a precision medicine portfolio update in relation to: TLX591-CDx (Illuccix® in approved jurisdictions, 68Ga-PSMA-11): Positive data from Phase 3 study in Chinese patients provides the basis for near-term NDA submission in China.TLX101-CDx (Pixclara®1, 18F-floretyrosine), PET imaging candidate for glioma: Following collaborative in...
Telix and Varian Announce Strategic Theranostics-EBRT Clinical Collabo...
Telix and Varian Announce Strategic Theranostics-EBRT Clinical Collaboration MELBOURNE, Australia and PALO ALTO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces a strategic clinical collaboration with Varian, a Siemens Healthineers company and global leader in radiation oncology, to develop novel clinical applications that combine Telix’s theranostic products and external beam radiation therapy (EBRT). EBRT is a widely used and validated treatment suitable for most solid malignant tumors. This treatment is typically...
ZIRCON-X Analysis: TLX250-CDx Impacts Clinical Decision Making for Alm...
ZIRCON-X Analysis: TLX250-CDx Impacts Clinical Decision Making for Almost Half of Patients with Indeterminate Renal Masses MELBOURNE, Australia and INDIANAPOLIS, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces results from the ZIRCON-X study which finds that almost half of all patients imaged with TLX250-CDx (Zircaix®1, 89Zr-DFO-girentuximab) PET/CT2 would have undergone a change in clinical management, when compared with baseline standard of care (SOC) imaging. The data will be presented at the 26th Annual Meeting of the So...
Telix to Participate in UBS and Jefferies Global Healthcare Conference...
Telix to Participate in UBS and Jefferies Global Healthcare Conferences MELBOURNE, Australia and INDIANAPOLIS, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) will participate in the upcoming UBS Global Healthcare Conference in Palm Beach, FL (U.S.) and in the Jefferies Global Healthcare Conference in London (UK). Kevin Richardson, Chief Executive Officer, Precision Medicine will take part in a fireside chat with UBS on Monday, November 10, 2025 at 12.30pm EST (Tuesday, Nov 11 at 4:30am AEDT). Richard Valeix, Chief Executive Officer, Ther...
TLX250-CDx (Zircaix) Included in Leading International Guidelines for ...
TLX250-CDx (Zircaix) Included in Leading International Guidelines for Renal Imaging MELBOURNE, Australia and INDIANAPOLIS, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today welcomes updated guidelines from the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the European Association of Nuclear Medicine (EANM) and The American College of Nuclear Medicine (ACNM) that, for the first time, include the use of Telix’s investigational PET1 agent, TLX250-CDx (Zircaix®2, 89Zr-DFO-girentuximab), for molecular imaging of renal masses. P...
Telix Doses First Patient in SOLACE Trial for Metastatic Bone Pain
Telix Doses First Patient in SOLACE Trial for Metastatic Bone Pain MELBOURNE, Australia and INDIANAPOLIS, Oct. 23, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that it has dosed the first patient in a Phase 1 clinical trial of TLX090 (153Samarium (Sm)-DOTMP), a therapeutic radiopharmaceutical candidate for treating pain associated with bone metastasis. TLX090 is designed to deliver targeted radiation to bone tumors while minimizing damage to surrounding healthy tissues. SOLACE (Samarium Optimized for Long-lasting Analgesia in Can...
Telix Reports US$206M Revenue, FY 2025 Guidance Upgraded
Telix Reports US$206M Revenue, FY 2025 Guidance Upgraded MELBOURNE, Australia and INDIANAPOLIS, Oct. 14, 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 September 2025 (Q3 2025). All figures are in USD unless stated otherwise. Q3 2025 Highlights Q3 2025 unaudited group revenue of approximately $206 million, up 53% year-over-year.FY 2025 revenue guidance increased to $800 million to $820 million1.Gozellix® now fully reimbursed by Centers for Medicare and...
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...
Unfortunately, this report is not available for the investor type or country you selected.
Report is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.