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The newsboard processes news from the NASDAQ Nordic portfolio company GlobeNewswire, which provides investors with company-relevant information. This relates in particular to events that may be relevant to the listing of companies or tradable financial instruments.
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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 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. 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. 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. 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.
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 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 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.
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