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First Patient Dosed in STARSTRUCK Study of TLX250 Targeted Radiation Therapy in Combination with Merck Investigational DNA-PK Inhibitor, Peposertib

MELBOURNE, Australia, July 19, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces that the first patient has been dosed in a Phase I study of the Company's investigational targeted radiation therapy, TLX250, in combination with a Merck KGaA, Darmstadt, Germany (Merck) DNA-dependent protein kinase (DNA-PK) inhibitor candidate, peposertib (M3814). The study is being conducted in patients with solid tumours expressing carbonic-anhydrase IX (CAIX), a potential pan-cancer target. STARSTRUCK (ClinicalTrials.gov Identifier: NCT05868174) is a Phase Ib, open label, single-arm, multicentre dose escalation and dose expansion study to evaluate the safety profile, dosing and activity of TLX250 (177Lu-DOTA-girentuximab) in combination with the DNA damage response inhibitor (DDRi) peposertib, which is an inhibitor of DNA-PK. The target population is patients with CAIX-expressing solid tumours that are relapsed or refractory to standard therapies. Up to ....

United States , United Kingdom , Merck Ddri , Nat Lenzo , Kyahn Williamson , Colin Hayward , Genesiscare Murdoch , Health Canada , Telix Pharmaceuticals , Merck Kga , European Union , Merck Kgaa , Australian Therapeutic Goods Administration , Prnewswire Telix Pharmaceuticals Limited , Genesiscare Group Clinical , Drug Administration , Australian Securities Exchange , Corporate Communications , Pharmaceuticals Limited , Professor Nat Lenzo , Genesiscare Group Clinical Director Theranostics , Chief Medical Officer , Telix Pharmaceuticals Limited , July 19 , 023 Prnewswire Telix Pharmaceuticals Limited Asx Tlx , He Company Today Announces That The First Patient Has Been Dosed Ina Phasei Study Of 39s Investigational Targeted Radiation Therapy ,

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 ,

First Patients in Canada Imaged with Illuccix: Now Commercially Available Nationwide

MELBOURNE, Australia, May 2, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces first patients have been imaged in Canada with its commercially available prostate cancer imaging agent, Illuccix [kit for the preparation of gallium (68Ga) PSMA-11 for intravenous injection]. With Illuccix now available nationwide in Canada through Telix's partner Isologic Innovative Radiopharmaceuticals (Isologic), INITIO Medical Group in Burnaby, BC (INITIO) became one of the first sites to administer this novel PSMA-PET imaging agent that can help healthcare professionals diagnose the stage and spread of prostate cancer - an important step for men with this disease. Illuccix, after radiolabeling with gallium (68Ga), is indicated for use with positron emission tomography (PET) of prostate specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are suitable for initial definitive therapy; with suspected re ....

United States , New Zealand , North Vancouver , British Columbia , Philip Cohen , Kevin Richardson , Andre Gagnon , Kyahn Williamson , Telix Pharmaceuticals Limited , Health Canada , Drug Administration , Group In Burnaby , Australian Securities Exchange , Telix Pharmaceuticals , Australian Therapeutic Goods Administration , Nuclear Medicine , Public Health Agency Of Canada , Corporate Communications , Division Head , Isologic Innovative Radiopharmaceuticals , Lions Gate Hospital , Chief Executive Officer , Telix Americas , Western Canada , Health Agency , May 2 ,

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 ,