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Telix to Supply Bayer with Illuccix for Global Phase III Prostate Cancer Study

MELBOURNE, Australia, May 8, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into an agreement with Bayer AG (Bayer) to supply Illuccix (TLX591-CDx, kit for the preparation of gallium Ga 68 gozetotide injection)[1] for the Phase III ARASTEP study (ClinicalTrials.gov Identifier: NCT05794906). This global study is investigating the efficacy of Bayer's androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence who have no evidence of metastatic disease by conventional imaging and a positive PSMA-PET/CT[2] at baseline. The study will enrol up to 750 patients across various sites such as in Europe, Japan and the United States. The more sensitive PSMA imaging may identify prostate cancer lesions not detectable by conventional imaging such as computed tomography (CT) scans, magnetic resonan ....

United States , United Kingdom , Bayer Cross , Kyahn Williamson , Colin Hayward , Orion Corporation , European Union , Prnewswire Telix Pharmaceuticals Limited , Corporate Communications , Drug Administration , Australian Securities Exchange , Health Canada , Australian Therapeutic Goods Administration , Telix Pharmaceuticals , Bayer Ag , Pharmaceuticals Limited , Chief Medical Officer , Telix Pharmaceuticals Limited , May 8 , 023 Prnewswire Telix Pharmaceuticals Limited Asx Tlx , He Company Today Announces That It Has Entered Into An Agreement With Bayer Ag To Supply Illuccix Tlx591 Cdx , It For The Preparation Of Gallium Ga 68 Gozetotide Injection 1 Phase Iii Arastep Study Clinicaltrials Gov Identifier Nct05794906 This Global Is Investigating Efficacy Bayer 39s Androgen Receptor Inhibitor Ari Darolutamide Plus Deprivation Therapy Adt Versus Alone In Hormone Sensitive Prostate Cancer , N Patients With High Risk Biochemical Recurrence Who Have No Evidence Of Metastatic Disease By Conventional Imaging Anda Positive Psma Pet Ct 2 At Baseline The Study Will Enrol Up To 750 Across Various Sites Such As In Europe , Apan And The United States More Sensitive Psma Imaging May Identify Prostate Cancer Lesions Not Detectable By Conventional Such As Computed Tomography Ct Scans , Agnetic Resonance Imaging Mri And Bone Scans Telix Chief Medical Officer , R Colin Hayward Stated ,

Chinese NMPA Approves Study of Telix Brain Cancer Therapy Candidate

MELBOURNE, Australia, April 11, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved a Phase I study of TLX101 investigational therapy (4-L-[131I] iodo-phenylalanine, or 131I-IPA) in Chinese patients with newly diagnosed glioblastoma (GBM). The investigational new drug (IND) application was submitted by Telix's partner in the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The Phase I study is required to establish the safety profile of this therapeutic candidate in a Chinese patient population, thus enabling Chinese patients to be enrolled in Telix's planned global pivotal registration trial for TLX101. This is the first of Telix's investigational therapies to move into a clinical trial with Grand Pharma. The IPAX-1 study of TLX101 (ClinicalTrials.gov Identifier: NCT03849105)met its primary objective d ....

Zhou Chao , United Kingdom , United States , Davidn Cade , Kyahn Williamson , Telix Asia Pacific , Prnewswire Telix Pharmaceuticals Limited , Corporate Communications , Australian Therapeutic Goods Administration , Australian Securities Exchange , Group Limited Grand Pharma , Health Canada , Telix Pharmaceuticals , Chinese National Medical Products Administration , Drug Administration , Pharmaceuticals Limited , Drug Evaluation , Greater China , Grand Pharmaceutical Group Limited , Grand Pharma , Asia Pacific , Telix Pharmaceuticals Limited , April 11 , 023 Prnewswire Telix Pharmaceuticals Limited Asx Tlx , He Company Today Announces The Chinese National Medical Products Administration Nmpa Center For Drug Evaluation Cde Has Approveda Phasei Study Of Tlx101 Investigational Therapy 4l 131i Iodo Phenylalanine , R 131i Ipa In Chinese Patients With Newly Diagnosed Glioblastoma Gbm The Investigational New Drug Ind Application Was Submitted By Telix 39s Partner Greater China Region ,

Chinese NMPA Approves Study of Telix Brain Cancer Therapy Candidate

MELBOURNE, Australia, April 11, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved a Phase I study of TLX101 investigational therapy (4-L-[131I] iodo-phenylalanine, or 131I-IPA) in Chinese patients with newly diagnosed glioblastoma (GBM). The investigational new drug (IND) application was submitted by Telix's partner in the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The Phase I study is required to establish the safety profile of this therapeutic candidate in a Chinese patient population, thus enabling Chinese patients to be enrolled in Telix's planned global pivotal registration trial for TLX101. This is the first of Telix's investigational therapies to move into a clinical trial with Grand Pharma. The IPAX-1 study of TLX101 (ClinicalTrials.gov Identifier: NCT03849105)met its primary objective d ....

Zhou Chao , United States , United Kingdom , Davidn Cade , Telix Asia Pacific , Kyahn Williamson , Telix Pharmaceuticals , Prnewswire Telix Pharmaceuticals Limited , Corporate Communications , Australian Securities Exchange , Chinese National Medical Products Administration , Australian Therapeutic Goods Administration , Group Limited Grand Pharma , Drug Administration , Health Canada , Pharmaceuticals Limited , Drug Evaluation , Greater China , Grand Pharmaceutical Group Limited , Grand Pharma , Asia Pacific , Telix Pharmaceuticals Limited , April 11 , 023 Prnewswire Telix Pharmaceuticals Limited Asx Tlx , He Company Today Announces The Chinese National Medical Products Administration Nmpa Center For Drug Evaluation Cde Has Approveda Phasei Study Of Tlx101 Investigational Therapy 4l 131i Iodo Phenylalanine , R 131i Ipa In Chinese Patients With Newly Diagnosed Glioblastoma Gbm The Investigational New Drug Ind Application Was Submitted By Telix 39s Partner Greater China Region ,

FDA Approves Expanded Indication for Telix's Illuccix to Include Patient Selection for PSMA-Directed Radioligand Therapy

MELBOURNE, Australia, March 16, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces that the United States Food and Drug Administration (FDA) has approved a supplementary New Drug Application (sNDA) for Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) to enable its use for the selection of patients with metastatic prostate cancer, for whom lutetium-177 (177Lu) PSMA-directed therapy is indicated.[1] The label expansion means Illuccix is now approved in the U.S. to identify and select patients who are candidates for the only FDA-approved prostate-specific membrane antigen (PSMA)- directed radioligand therapy (Pluvicto),[2] providing doctors with critical information to guide patient management and help optimise treatment outcomes. To qualify for radioligand therapy, patients must be imaged with an approved gallium-based PSMA-PET agent.[3] As the only diagnostic agent for prostate cancer that combines the accuracy of gall ....

United States , United Kingdom , Kyahn Williamson , Kevin Richardson , Oliver Sartor , Telix Pharmaceuticals , Drug Administration , Tulane Cancer Center , Australian Securities Exchange , Prnewswire Telix Pharmaceuticals Limited , Australian Therapeutic Goods Administration , Corporate Communications , Health Canada , American Cancer Society , Pharmaceuticals Limited , United States Food , New Drug Application , Chief Executive Officer , Telix Americas , Medical Director , Telix Pharmaceuticals Limited , Emission Tomography , Computed Tomography , Cancer Society , Key Statistics , Prostate Cancer ,

Telix's ZIRCON Phase III Kidney Cancer Imaging Study Presented in "Game Changing" Session at EAU

MELBOURNE, Australia, March 14, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces additional positive results from its completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118).1 The results were featured in a "Game Changing" oral session delivered by Professor Dr. Peter Mulders from Radboud University Medical Centre (Netherlands), a ZIRCON Principal Investigator, at the 38th Annual European Association of Urology (EAU) Congress, on Saturday, 11 March 2023. Game Changing sessions are reserved for Phase III trials or other developments that the EAU's Scientific Congress Office believes will have a large impact on daily practice. New data presented: TLX250-CDx demonstrated a high degree of consistency between readers with a very high sensitivity (85.5%) and specificity (87.0%) overall, and 85.5% / 89.5% for small masses ....

United States , United Kingdom , Kyahn Williamson , Peter Mulders , European Association Of Urology , Telix Pharmaceuticals , Drug Administration , Australian Securities Exchange , Prnewswire Telix Pharmaceuticals Limited , Australian Therapeutic Goods Administration , Radboud University Medical Centre Netherlands , Corporate Communications , Scientific Congress Office , Health Canada , Pharmaceuticals Limited , Radboud University Medical Centre , Annual European Association , Congress Office , About Telix Pharmaceuticals Limited , Telix Pharmaceuticals Limited , March 14 , 023 Prnewswire Telix Pharmaceuticals Limited Asx Tlx , He Company Today Announces Additional Positive Results From Its Completed Pivotal Phase Iii Zircon Study Of Tlx250 Cdx 89zr Dfo Girentuximab In Clear Cell Renal Carcinoma Ccrcc Clinicaltrials Gov Identifier Nct03849118 1 The Were Featured Ina Quot Game Changing Oral Session Delivered By Professor Dr Peter Mulders Radboud University Medical Centre Netherlands , A Zircon Principal Investigator , T The 38th Annual European Association Of Urology Eau Congress , On Saturday ,