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MELBOURNE, Australia, Nov. 28, 2024 /PRNewswire/ -- 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.
MELBOURNE, Australia, Nov. 19, 2024 /PRNewswire/ -- 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. 19, 2024 /PRNewswire/ -- 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, Germany, Nov. 13, 2024 /PRNewswire/ -- 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. 4, 2024 /PRNewswire/ -- 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 advanced imaging agents for all patients into the future.
MELBOURNE, Australia, Oct. 30, 2024 /PRNewswire/ -- 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).
Subtle Medical's SubtlePET™ is a U.S. Food and Drug Administration (FDA) cleared AI-driven solution to enhance the efficiency and effectiveness of imaging procedures. The proprietary deep-learning algorithm allows for faster PET scanning – up to 75% time savings without compromising image quality. The technology represents a significant advancement in the field, offering numerous benefits to patients, physicians, and medical facilities.
MELBOURNE, Australia, Oct. 24, 2024 /PRNewswire/ -- 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].
MELBOURNE, Australia, Oct. 22, 2024 /PRNewswire/ -- 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).
Rhine Pharma was formed following a collaboration between Telix and Heidelberg University Hospital (UKHD), which aimed to develop a PSMA[2]-targeting small molecule that could be labelled with either 99mTc for SPECT[3] imaging, or 188Re for radioligand therapy. The collaboration successfully created a potential next-generation theranostic compound, RHN001[4], which Rhine Pharma is now advancing into a novel Phase I/IIa theranostic clinical study (the 'RHINO Trial'), exploring the safety profile and efficacy of both 99mTc-RHN001 and 188Re-RHN001 in patients with advanced prostate cancer.
MELBOURNE, Australia, Oct. 22, 2024 /PRNewswire/ -- 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).
Rhine Pharma was formed following a collaboration between Telix and Heidelberg University Hospital (UKHD), which aimed to develop a PSMA[2]-targeting small molecule that could be labelled with either 99mTc for SPECT[3] imaging, or 188Re for radioligand therapy. The collaboration successfully created a potential next-generation theranostic compound, RHN001[4], which Rhine Pharma is now advancing into a novel Phase I/IIa theranostic clinical study (the 'RHINO Trial'), exploring the safety profile and efficacy of both 99mTc-RHN001 and 188Re-RHN001 in patients with advanced prostate cancer.
MELBOURNE, Australia, Oct. 18, 2024 /PRNewswire/ -- 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).