ASX - Delayed Quote • AUD Telix Pharmaceuticals Limited (TLX.AX) Follow Compare 24.74 -0.93 (-3.62%) At close: December 20 at 4:10:12 PM GMT+11 All News Press Releases SEC Filings All SEC Filings Corporate Changes & Voting Matters Periodic Financial Reports Proxy Statements Tender Offer/Acquisition Reports Offering Registrations Telix Manufacturing Solutions, Brussels South Update: Cyclotron Installation Complete MELBOURNE, Australia, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces that it has completed the installation of two new cyclotrons at Telix Manufacturing Solutions (TMS) in Brussels South, Belgium, facilitating the production of radioisotopes and patient doses on-site from 20251. The installation of cyclotrons from GE HealthCare and IBA (Ion Beam Applications S.A.), along with proprietary solid targets, establishes TMS B First Patient Dosed in Phase III ZIRCON-CP Trial of TLX250-CDx for Kidney Cancer Imaging in Chinese Patients Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) and Grand Pharmaceutical Group Limited (00512.HK, Grand Pharma) today announce that a first patient has been dosed in the Phase III ZIRCON-CP trial of TLX250-CDx positron emission tomography (PET) imaging of clear cell renal cell carcinoma (ccRCC). The patient was successfully dosed and imaged at Beijing Cancer Hospital in Beijing, China. Telix to Add FAP-Targeting Candidates to Theranostic Pipeline MELBOURNE, Australia, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces it will expand its theranostic pipeline with new assets targeting Fibroblast Activation Protein (FAP), one of the most promising pan-cancer targets in nuclear medicine. Telix’s development program will initially focus on the treatment of bladder cancer, rounding out its urology franchise, which includes late-stage therapeutic programs for kidney and pr Telix ADSs Commence Trading on Nasdaq MELBOURNE, Australia, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) announces that its American Depository Shares (ADSs) have commenced trading on the Nasdaq Global Select Market (Nasdaq) under the ticker symbol ‘TLX’. The Company continues to have its primary listing on ASX, with the Nasdaq listing of ADSs expected to complement the Company’s ASX listing. Each ADS represents one fully paid ordinary share of the Company. Telix has not Telix and Eckert & Ziegler to Partner on Actinium-225 Production Technology MELBOURNE, Australia and BERLIN, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into a technology collaboration and licence agreement with Berlin-based Eckert & Ziegler SE (EZAG) for the use of EZAG’s cyclotron-based systems to produce the alpha-emitting isotope, actinium-225 (225Ac). This provides Telix with both an additional commercial source of 225Ac and access to a platform technology that enables highly eff Telix Welcomes CMS Decision to Improve Payments for Diagnostic Radiopharmaceuticals Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today welcomes the announcement by the United States (U.S.) Centers for Medicare & Medicaid Services (CMS) that it will pay separately for specialised diagnostic radiopharmaceuticals[1] for Medicare Fee for Service patients in the hospital outpatient setting, beyond the transitional pass-through payment period ("pass-through"). This is a significant decision for patients and hospitals, with the change facilitating equitable access to a Telix Partners with Subtle Medical on AI-Enabled SubtlePET™ Software for Faster PET Imaging with Illuccix® Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces a partnership with California-based Subtle Medical, Inc. (Subtle Medical) for artificial intelligence (AI)-powered positron emission tomography (PET) imaging with Telix's commercial PSMA-PET[1] product, Illuccix® (68Ga-PSMA-11). FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara®[1]), an agent for the imaging of glioma. The application has been granted priority review and designated a PDUFA[2] goal date of 26 April 2025, paving the way for a U.S. commercial launch in 2025[3]. Telix Spins Off Rhine Pharma™ to Expand Global Access to Radiopharmaceuticals Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces the spin-off of Rhine Pharma[1], which has the mission of expanding global access to innovative radiopharmaceuticals for cancer imaging and treatment using two generator-produced isotopes, technetium-99m (99mTc) and rhenium-188 (188Re). Telix Files Form 20-F Registration Statement for Nasdaq ADS Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) announces that it has publicly filed a Form 20-F registration statement (Registration Statement) with the United States (U.S.) Securities and Exchange Commission (SEC) relating to a proposed listing of American Depository Shares (ADS), representing the Company's ordinary shares, on the Nasdaq Stock Market (Nasdaq). Telix Q3 2024 Business Update - Quarterly Revenue Exceeds AU$200M Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today provides an update on its revenue and operational performance for the quarter ended 30 September 2024 (Q3 2024). Australian TGA Approves Additional Indication for Telix's Illuccix® to Include Patient Selection for PSMA-Targeted Therapy Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Australian Therapeutic Goods Administration (TGA) has approved the use of Illuccix® (kit for the preparation of 68Ga-PSMA-11[1] injection) to select patients for PSMA[2]-targeted radionuclide therapy. Health Canada Approves Label Expansion for Telix’s Illuccix® to Include Patient Selection for PSMA-Targeted Therapy MELBOURNE, Australia, Oct. 04, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that Health Canada has approved the use of Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) in selecting patients for PSMA1-targeted radionuclide therapy. The label expansion means that Illuccix is now approved in Canada to select patients with progressive metastatic castration-resistant prostate cancer (mCRPC) for treatment with the only a First Patient Dosed in Phase II 'CA-NINE' Trial of TLX250-CDx for Detection of Recurrent Kidney Cancer After Surgery Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first patient has been dosed in a Phase II trial exploring the clinical utility of Telix's first-in-class investigational PET[1] agent, TLX250-CDx (89Zr-girentuximab) in recurrent clear cell renal cell carcinoma (ccRCC) after surgery. Telix Pharmaceuticals (ASX:TLX) Boosts Growth with Cardinal Health Alliance and New FDA Submissions Telix Pharmaceuticals (ASX:TLX) is experiencing significant growth, marked by a 65% revenue increase in the first half of 2024 and a raised revenue guidance. However, the company faces challenges such as high valuation and market competition. In the discussion that follows, we will explore Telix's core strengths, critical issues, growth opportunities, and potential threats to provide a comprehensive overview of its current business situation. Telix to Acquire RLS to Expand North American Manufacturing and Distribution Platform Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) and RLS (USA) Inc. (RLS, RLS Radiopharmacies), America's only Joint Commission-accredited radiopharmacy network distributing PET[1], SPECT[2] and therapeutic radiopharmaceuticals, today announced an agreement by the Company to acquire RLS from its parent company, RLS Group Ltd. The acquisition significantly expands Telix's North American manufacturing footprint and establishes the basis of a next generation radiometal production networ Telix Announces Cardinal Health as U.S. Commercial Distributor for Zircaix® Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has selected Cardinal Health, Inc. (NYSE: CAH, Cardinal Health) as a commercial radiopharmaceutical distributor to supply finished unit doses of its PET[1] agent, Zircaix®[2] (TLX250-CDx) for the imaging of kidney cancer in the United States (U.S.), subject to regulatory approval. 'Highly Accurate': Telix's Phase III ZIRCON Trial for Kidney Cancer Imaging Published in The Lancet Oncology Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that primary results from its Phase III ZIRCON[1] trial have been published in The Lancet Oncology, reporting that Telix's first-in-class investigational PET[2] agent, TLX250-CDx (Zircaix®[3], 89Zr-girentuximab), is highly accurate in detecting and characterising clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses (IRMs). IPAX-1 Study of TLX101 Investigational Glioblastoma Therapy Published in Neuro-Oncology Advances Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Company's IPAX-1 Phase I study has been published in Neuro-Oncology Advances, confirming the safety and tolerability profile, and early efficacy of TLX101 therapy, in combination with external beam radiation therapy (EBRT) in recurrent glioblastoma (GBM), the most common and aggressive form of primary brain cancer. Telix Submits NDA for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-CDx, (Pixclara®[1], 18F-floretyrosine or 18F-FET), an investigational PET[2] agent for the characterisation of progressive or recurrent glioma (brain cancer) from treatment related changes in both adult and pediatric patients. Performance Overview Trailing total returns as of 12/20/2024, which may include dividends or other distributions. Benchmark is S&P/ASX 200 [XJO] Return TLX.AX S&P/ASX 200 [XJO] YTD +145.44% +6.27% 1-Year +151.93% +7.02% 3-Year +234.32% +10.63%