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).

MELBOURNE, Australia, Oct. 17, 2024 /PRNewswire/ -- 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).

Revenue update, full year guidance reaffirmed

Unaudited total revenue of approximately US$135 million (AU$201 million[1]), primarily generated from sales of Telix's prostate cancer imaging product Illuccix® in the Precision Medicine (Px) business unit. This represents an increase of 55% on the prior corresponding quarter (Q3 2023: US$87 million or AU$133 million) and an increase of 9% on the prior quarter (Q2 2024: US$124 million or AU$189 million).Revenue generated from sales of Illuccix in the United States (U.S.) was approximately US$131 million (AU$195 million).Total revenue[2] generated for the year to date is US$374 million (AU$565 million).The Company reaffirms its full year 2024 revenue guidance of US$490 million to US$510 million (AU$745 million to AU$776 million), representing a ~48 to 54% increase on full year 2023.Guidance for full year 2024 R&D expenditure remains at an expected 40 to 50% increase compared with full year 2023, funded by earnings from product sales.Revenue guidance is based on approved products in jurisdictions with a marketing authorisation. (See Guidance Disclaimer for further information).

MELBOURNE, Australia, Oct. 16, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces thirteen abstract presentations featuring the Company's ongoing theranostic development, medical technologies (MedTech), and research and innovation (R&I) programs at the 37th Annual Congress of the European Association of Nuclear Medicine (EANM) to be held in Hamburg from 19 – 23 October 2024.

Telix's extensive theranostic pipeline will be showcased in presentations covering: TLX250-CDx  (Zircaix®[1], 89Zr-girentuximab) kidney cancer imaging, including first real-world clinical experience; TLX101 (131I-iodofalan or 131I-IPA) glioblastoma therapy; TLX66 (90Y-besilesomab) bone marrow conditioning therapy; TLX252 (225Ac-girentuximab) carbonic anhydrase IX (CAIX)-targeted alpha therapy; and SENSEI®, Lightpoint's robotic-assisted gamma probe.

MELBOURNE, Australia, Oct. 8, 2024 /PRNewswire/ -- 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.

Illuccix remains the only PSMA-PET[3] agent approved in Australia, manufactured to GMP[4] standards, and listed on the Medicare Benefits Schedule (MBS) for imaging patients with prostate cancer. This label expansion means that it is now approved to select patients with metastatic prostate cancer for treatment with the only approved PSMA-targeted radionuclide therapy (Lu 177 vipivotide tetraxetan, or Pluvicto®[5]). To qualify for PSMA-targeted therapy, patients should be identified by PSMA imaging[6].

MELBOURNE, Australia, Oct. 4, 2024 /PRNewswire/ -- 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.

'CA-NINE'[2] – led by Professor Brian Shuch at University of California, Los Angeles (UCLA) – is a Phase II prospective, single-centre trial comparing the diagnostic performance of TLX250-CDx PET/CT[3] to conventional imaging (contrast-enhanced CT alone) in 91 patients with intermediate-to-high risk ccRCC post-surgery. The investigator-initiated trial is designed to identify ccRCC where it has recurred, including metastatic disease, and is one of multiple trials either underway or planned, which may inform future label expansion for TLX250-CDx.

MELBOURNE, Australia, INDIANAPOLIS and LAKE MARY, Fla., Sept. 23, 2024 /PRNewswire/ -- 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 network to benefit Telix and select strategic commercial partners. 

MELBOURNE, Australia, INDIANAPOLIS and LAKE MARY, Fla., Sept. 23, 2024 /PRNewswire/ -- 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 network to benefit Telix and select strategic commercial partners. 

MELBOURNE, Australia, Sept. 18, 2024 /PRNewswire/ -- 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.

In preparation for a planned commercial rollout, Telix has contracted with Cardinal Health to enable Zircaix®[2] availability across a wide range of U.S. locations.

MELBOURNE, Australia, Sept. 10, 2024 /PRNewswire/ -- 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).

In this peer-reviewed manuscript, Professor Brian Shuch (University of California, Los Angeles, UCLA) and colleagues report results from this prospective, open-label, multicentre, Phase III trial in which 300 patients with an IRM ≤7cm (cT1) received TLX250-CDx. Authors conclude that TLX250-CDx "has a favourable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterisation of ccRCC, which has the potential to be practice changing."

MELBOURNE, Australia, Sept. 11, 2024 /PRNewswire/ -- 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).

MELBOURNE, Australia, Sept. 4, 2024 /PRNewswire/ -- 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.

TLX101 (4-L-[ 131I] iodo-phenylalanine, or 131I-IPA) is a systemically administered targeted radiation therapy that targets L-type amino acid transporter 1 (LAT1), which is typically over-expressed in GBM.