Articles from Telix Pharmaceuticals Limited

MELBOURNE, Australia and INDIANAPOLIS, Jan. 31, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces it has completed the acquisition from antibody engineering company ImaginAb, Inc. (ImaginAb). The acquisition includes a pipeline of next-generation therapeutic candidates, a proprietary novel biologics technology platform, and a protein engineering and discovery research facility to enhance existing innovation capabilities1.

MELBOURNE, Australia and INDIANAPOLIS, Jan. 28, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces it has completed the acquisition of RLS (USA) Inc. (RLS; RLS Radiopharmacies), America’s only Joint Commission-accredited radiopharmacy network distributing PET1, SPECT2 and therapeutic radiopharmaceuticals.

MELBOURNE, Australia and LIÈGE, Belgium, Jan. 17, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that it has received a positive decision on the Marketing Authorization Application (MAA) for its prostate cancer PET1 imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection), which was submitted in Europe via a decentralized procedure (DCP).

MELBOURNE, Australia and INDIANAPOLIS, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today advises that Dr. Christian Behrenbruch, Managing Director and Group CEO, will be presenting this week at the 43rd Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA (U.S.A.). 

MELBOURNE, Australia and INDIANAPOLIS, Jan. 13, 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 December 2024 (Q4 2024).

MELBOURNE, Australia and INDIANAPOLIS, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces it has entered into an asset purchase agreement with antibody engineering company ImaginAb, Inc. (ImaginAb) to acquire a pipeline of next-generation therapeutic candidates, proprietary novel biologics technology platform, and a protein engineering and discovery research facility to enhance existing innovation capabilities.

MELBOURNE, Australia and BRUSSELS, Dec. 31, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) and the Brussels-based Oncidium foundation today announce that results for the NOBLE Registry of TLX599-CDx (99mTc-iPSMA) have been published in the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) Reports.

MELBOURNE, Australia and INDIANAPOLIS, Dec. 30, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix®1, 89Zr- girentuximab) kidney cancer imaging2.

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.

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 prostate cancers.

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’.

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 efficient, scalable isotope production for use in the development of next generation targeted alpha therapies (TATs), a strategic focus for Telix.

MELBOURNE, Australia, Nov. 04, 2024 (GLOBE NEWSWIRE) -- 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 specialized diagnostic radiopharmaceuticals1 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 advanced imaging agents for all patients into the future. 

MELBOURNE, Australia, Oct. 30, 2024 (GLOBE NEWSWIRE) -- 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-PET1 product, Illuccix® (68Ga-PSMA-11).

MELBOURNE, Australia, Oct. 24, 2024 (GLOBE NEWSWIRE) -- 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 PDUFA2 goal date of 26 April 2025, paving the way for a U.S. commercial launch in 20253.

MELBOURNE, Australia, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces the spin-off of Rhine Pharma1, 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).

MELBOURNE, Australia, Oct. 18, 2024 (GLOBE NEWSWIRE) -- 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).

MELBOURNE, Australia, Oct. 17, 2024 (GLOBE NEWSWIRE) -- 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).

MELBOURNE, Australia, Oct. 03, 2024 (GLOBE NEWSWIRE) -- 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 PET1 agent, TLX250-CDx (89Zr-girentuximab) in recurrent clear cell renal cell carcinoma (ccRCC) after surgery.

MELBOURNE, Australia and INDIANAPOLIS, Ind. and LAKE MARY, Fla., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) and RLS (USA) Inc. (RLS, RLS Radiopharmacies), America’s only Joint Commission-accredited radiopharmacy network distributing PET1, SPECT2 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 network to benefit Telix and select strategic commercial partners.

MELBOURNE, Australia, Sept. 17, 2024 (GLOBE NEWSWIRE) -- 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 PET1 agent, Zircaix®2 (TLX250-CDx) for the imaging of kidney cancer in the United States (U.S.), subject to regulatory approval.

MELBOURNE, Australia, Sept. 11, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that primary results from its Phase III ZIRCON1 trial have been published in The Lancet Oncology, reporting that Telix’s first-in-class investigational PET2 agent, TLX250-CDx (Zircaix®3, 89Zr-girentuximab), is highly accurate in detecting and characterizing clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses (IRMs).

MELBOURNE, Australia, Sept. 04, 2024 (GLOBE NEWSWIRE) -- 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.

MELBOURNE, Australia, Aug. 28, 2024 (GLOBE NEWSWIRE) -- 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 PET2 agent for the characterization of progressive or recurrent glioma (brain cancer) from treatment related changes in both adult and pediatric patients.

MELBOURNE, Australia, Aug. 27, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces new leadership appointments as part of an internal reorganisation to align its operations across four business units, reflecting its focus as a therapeutics-led radiopharmaceutical company committed to precision oncology.

MELBOURNE, Australia, Aug. 22, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces its financial results for the half-year ended 30 June 2024. All figures are in AU$ unless otherwise stated.1

MELBOURNE, Australia, July 29, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) 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.        

MELBOURNE, Australia, July 24, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) 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.

MELBOURNE, Australia, July 18, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today provides an update on its revenue and operational performance for the quarter ended 30 June 2024 (Q2 2024).

MELBOURNE, Australia, July 11, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) 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 radiopharmaceuticals1 for Medicare patients in the United States (U.S.), facilitating continued patient access after transitional pass-through payment status expires.

MELBOURNE, Australia, June 05, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (the “Company” or “Telix”) today announces the launch of its initial public offering in the United States (the “Offering”) of 17,000,000 American Depositary Shares (“ADSs”), each representing one ordinary share in Telix. The target size of the Offering is US$200 million in gross proceeds. In addition, Telix expects to grant the Underwriters (as defined below) a 30-day option to purchase up to an additional 15% of the number of ADSs sold in the Offering at the initial public offering price, less underwriting discounts and commissions. All ADSs to be issued in the Offering will be offered by Telix.

MELBOURNE, Australia, June 03, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) 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 PET1 agent, TLX250-CDx (Zircaix™2, 89Zr-DFO-girentuximab), for the characterisation of renal masses as clear cell renal cell carcinoma (ccRCC).

MELBOURNE, Australia, May 31, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces additional positive data from the ProstACT SELECT trial (“SELECT”) of TLX591 (177Lu rosopatamab tetraxetan), a lutetium-labelled rADC therapy for the treatment of adult patients with PSMA-positive metastatic castrate-resistant prostate cancer (mCRPC). SELECT is a radiogenomics study intended to evaluate lesion concordance between 68Ga (gallium)-based PSMA-PET4 imaging and TLX591 dosimetry for the purpose of validating PET imaging for patient selection for rADC therapy. The Company has previously reported final safety data from this study3.

MELBOURNE, Australia, May 28, 2024 (GLOBE NEWSWIRE) -- 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 TLX007-CDx, a new and proprietary cold kit (“Kit”) for the preparation of PSMA-PET imaging1 for prostate cancer.

MELBOURNE, Australia, May 21, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces the successful completion of CUPID1, a first-in-human Phase I dose escalation study of TLX592 in patients with advanced prostate cancer.

MELBOURNE, Australia, May 17, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has filed a registration statement on Form F-1 (Registration Statement) with the United States (U.S.) Securities and Exchange Commission (SEC) today (U.S. time) relating to a proposed initial public offering (Offering) of its American Depository Shares (ADSs), representing the Company’s ordinary shares, in the U.S. Telix has applied to list the ADSs on the Nasdaq Global Market under the symbol “TLX”.

MELBOURNE, Australia, April 17, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today provides an update on its revenue and operational performance for the quarter ended 31 March 2024 (Q1 2024).

MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™2, 18F-floretyrosine or 18F-FET).

MELBOURNE, Australia and DRESDEN, Germany, March 19, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into an agreement to commercially partner the QDOSE® dosimetry software platform with ABX-CRO Advanced Pharmaceutical Services Forschungsgesellschaft mbH (ABX-CRO), a full-service contract research organization (CRO) based in Dresden, and its development partner, Stockholm-based Quantinm AB.

MELBOURNE, Australia, March 12, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) is pleased to announce the appointment of Dr. Darren Patti as Group Chief Operating Officer (COO), effective 11 March 2024.

MELBOURNE, Australia, March 05, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has entered into an agreement to acquire radioisotope production technology firm ARTMS Inc. (ARTMS), its advanced cyclotron-based isotope production platform, manufacturing plant and stockpile of ultra-pure rare metals required for consumable target production.

MELBOURNE, Australia, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has entered into an agreement to acquire IsoTherapeutics Group, LLC (IsoTherapeutics), a specialty radiopharmaceutical development and bioconjugation firm, based in Angleton, Texas. Founded in 2005, IsoTherapeutics is a privately held, commercial-stage company, which provides radiochemistry and bioconjugation development and contract manufacturing services to many companies in the radiopharmaceutical industry, including Telix.

MELBOURNE, Australia, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces its results for the financial year ended 31 December 2023. All figures are in AUD$ unless otherwise stated.1

MELBOURNE, Australia, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has entered into an agreement to acquire QSAM Biosciences, Inc. (U.S. OTC: QSAM) and its lead investigational drug Samarium-153-DOTMP (153Sm-DOTMP). QSAM is a United States (U.S.) based company developing therapeutic radiopharmaceuticals for primary and metastatic bone cancer.

MELBOURNE, Australia, Jan. 22, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces presentations featuring the Company’s theranostic programs at the upcoming American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2024) to be held in San Francisco, CA (US) from 25 – 27 January 2024.

MELBOURNE, Australia, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX:TLX, “Telix” or the “Company”) today announces that it is considering an initial public offering (“IPO”) of American Depositary Shares (“ADSs”) representing its ordinary shares in the United States (“U.S.”) and listing on the Nasdaq Global Market (“Nasdaq”). Telix’s ordinary shares will remain listed on the Australian Securities Exchange.

MELBOURNE, Australia, Jan. 03, 2024 (GLOBE NEWSWIRE) --  Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today advises that Dr Christian Behrenbruch, Managing Director and Group CEO, will be presenting at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA (US).

Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has commenced a collaboration with Kettering Health (KH), a faith-based network of 13 hospitals, emergency centers, and outpatient facilities located in Southwest Ohio; headquartered at the Kettering Memorial Hospital in Kettering, Ohio, United States.

Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announced the launch of TelixU, a new educational platform focused on radiopharmaceutical research in partnership with leading medical imaging journal, Applied Radiology. This website is specifically designed for healthcare professionals such as physicians and technologists, and features case studies, webinars, and technologist education.

Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announced the launch of a new website “Gallium Wave” (galliumwave.com), as part of the Company's gallium awareness campaign.

As interest and demand for more accurate prostate cancer imaging grows, and with the approval of the first Ga-68 PSMA based prostate imaging agent late last year1, Cardinal Health Nuclear & Precision Health Solutions (Cardinal Health) and Telix Pharmaceuticals (US) Inc. (Telix) have developed an in-depth white-paper, entitled: “Moving beyond the Myth: Meeting the growing demand for Ga-68 radiopharmaceuticals.” The paper shines a light on the pathways for radio-isotope production, distribution and clinical application, as well as highlighting the extensive systems already in place to help ensure potential demand for Ga-68 imaging products is met.