MELBOURNE, Australia and INDIANAPOLIS, April 15, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces preliminary results from the Phase 2 IPAX-Linz study of TLX101 (131I-iodofalan[1]) in recurrent high-grade glioma (brain cancer), substantiating the patient benefit seen in the IPAX-1 study[2].

IPAX-Linz is a single-arm Phase 2 investigator-initiated trial (IIT). IPAX-Linz evaluates the safety, tolerability and preliminary efficacy of TLX101 therapy, in combination with external beam radiation therapy (EBRT). The target patient population is patients at first or second recurrence with high-grade gliomas (HGG), including glioblastoma.

MELBOURNE, Australia and INDIANAPOLIS, April 16, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces preliminary results from the Phase 2 IPAX-Linz study of TLX101 (131I-iodofalan[1]) in recurrent high-grade glioma (brain cancer), substantiating the patient benefit seen in the IPAX-1 study[2].

IPAX-Linz is a single-arm Phase 2 investigator-initiated trial (IIT). IPAX-Linz evaluates the safety, tolerability and preliminary efficacy of TLX101 therapy, in combination with external beam radiation therapy (EBRT). The target patient population is patients at first or second recurrence with high-grade gliomas (HGG), including glioblastoma.

MELBOURNE, Australia, April 15, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by the Swedish MPA[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enables healthcare providers in Sweden to offer PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical.

MELBOURNE, Australia and INDIANAPOLIS, April 7, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that is has appointed Dr. Paul Schaffer to the newly created role of Chief Technology Officer (CTO), effective today.  

Dr. Schaffer has been CTO at ARTMS Inc. (ARTMS) (acquired by Telix in 2024) for the past seven years, as well as Director, Life Science at TRIUMF, Canada's particle accelerator research centre, since 2012. Based in Vancouver, Canada, Dr. Schaffer is widely recognized for his role in the buildout and transformation of the TRIUMF Life Sciences program, which included design and construction of a major multi-cyclotron radiochemistry facility and the development of the ARTMS QUANTM Irradiation System® (QIS®) for large-scale isotope production, which was commercialized and later acquired by Telix.

MELBOURNE, Australia, April 2, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that a first patient has been dosed in the Phase 1 ZOLAR[1] trial of TLX300-CDx (89Zr-olaratumab) in patients with advanced, metastatic soft tissue sarcoma (STS) at the Melbourne Theranostic Innovation Centre (MTIC) in Melbourne, Australia.

MELBOURNE, Australia and INDIANAPOLIS, March 21, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix's next-generation PSMA-PET imaging[1] agent for prostate cancer.

MELBOURNE, Australia and PORTO ALEGRE, Brazil, March 18, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or 'ANVISA') has approved Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) the Company's lead prostate cancer imaging agent. Illuccix® is the first and only PSMA-PET[1] prostate cancer imaging agent to receive full regulatory approval in Brazil.

MELBOURNE, Australia and PORTO ALEGRE, Brazil, March 18, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or 'ANVISA') has approved Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) the Company's lead prostate cancer imaging agent. Illuccix® is the first and only PSMA-PET[1] prostate cancer imaging agent to receive full regulatory approval in Brazil.

MELBOURNE, Australia and INDIANAPOLIS, March 13, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that it has developed and validated a breakthrough generator technology for the production of lead-212 (212Pb) and successfully completed first production.

The new generator technology, developed internally by Telix's IsoTherapeutics team, produces 212Pb via a sealed Thorium-228 (228Th) source, and significantly increases the amount of radioactivity, yield and shelf life compared to currently available 212Pb generators. The fully automated, high-output generators have a small, single hot cell footprint and produce sufficient 212Pb elution for up to 60 clinical doses, with the potential to further scale. The production footprint has been designed to be deployed throughout Telix's (and select partner) manufacturing and distribution networks, including the recently acquired RLS Radiopharmacies network. This development builds on Telix's extensive experience with developing generator-based radiopharmaceutical products.

MELBOURNE, Australia and INDIANAPOLIS, March 13, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that it has developed and validated a breakthrough generator technology for the production of lead-212 (212Pb) and successfully completed first production.

The new generator technology, developed internally by Telix's IsoTherapeutics team, produces 212Pb via a sealed Thorium-228 (228Th) source, and significantly increases the amount of radioactivity, yield and shelf life compared to currently available 212Pb generators. The fully automated, high-output generators have a small, single hot cell footprint and produce sufficient 212Pb elution for up to 60 clinical doses, with the potential to further scale. The production footprint has been designed to be deployed throughout Telix's (and select partner) manufacturing and distribution networks, including the recently acquired RLS Radiopharmacies network. This development builds on Telix's extensive experience with developing generator-based radiopharmaceutical products.

MELBOURNE, Australia and INDIANAPOLIS, Ind., March 4, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) invites investors to join a webinar showcasing the Company's late-stage and next-generation radiotherapeutic candidates in urologic oncology.

In this education session, Telix and global key opinion leaders will provide an overview on the development of its therapeutic candidates in prostate and kidney cancers:

MELBOURNE, Australia, Feb. 26, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET[1] imaging agent TLX250-CDx  (Zircaix®[2], 89Zr-DFO-girentuximab), granted a Priority Review and provided a PDUFA[3] date of 27 August 2025, paving the way for a U.S. commercial launch in 2025.

MELBOURNE, Australia, Feb. 25, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by ALMPS[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enables healthcare providers in Luxembourg to offer PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical.

MELBOURNE, Australia, Feb. 24, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by NOMA[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enables healthcare providers in Norway to offer PSMA-PET[3] imaging using a clinically-validated gallium-based radiopharmaceutical.

MELBOURNE, Australia and INDIANAPOLIS, Ind., Feb. 20, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces its financial results for the year ended 31 December 2024. All figures are in AU$ unless stated otherwise.

FY2024 highlights

Total revenue, driven primarily from sales of Illuccix® of $783.2 million, up by 56%1 from $502.5 million in 2023, beating full year guidance2.Second year of profitable growth, delivered in a period of investment, including:R&D investment of $194.6 million, in line with guidance, with a focus on late-stage assets.Expanded global supply chain and product delivery infrastructure, including acquisitions of ARTMS, Inc. and IsoTherapeutics Group, LLC, and expansion of Telix Manufacturing Solutions' Brussels South facility, resulting in an incremental increase of $15.8 million in manufacturing and distribution investment.Adjusted EBITDA of $99.3 million, up by 70%, demonstrating strong underlying growth3.Telix continued to deliver on its growth strategy. The Company's key achievements, aligned to its strategic pillars:Grow precision medicine: Prepared for launch of three new products TLX007-CDx (Gozellix®), TLX101-CDx (Pixclara®) and TLX250-CDx (Zircaix®)4 in 2025 while continuing to increase sales and market share for Illuccix®.Deliver late-stage therapeutics: Expanded ProstACT GLOBAL Phase 3 prostate cancer therapy trial recruitment in the U.S. and continued to advance therapeutic trials for the brain and kidney cancer programs.Build next generation pipeline: Delivered clinical proof-of-concept for first alpha therapy candidate in prostate cancer (TLX592) and added depth to urology franchise with acquisition of FAP5-targeting theranostic.Expand global delivery infrastructure: Completed acquisitions of ARTMS, IsoTherapeutics and RLS (USA), Inc. (RLS)6 and expanded Brussels South facility, in preparation to commence GMP7 production in 2025.

MELBOURNE, Australia and INDIANAPOLIS, Ind., Feb. 20, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces its financial results for the year ended 31 December 2024. All figures are in AU$ unless stated otherwise.

FY2024 highlights

Total revenue, driven primarily from sales of Illuccix® of $783.2 million, up by 56%1 from $502.5 million in 2023, beating full year guidance2.Second year of profitable growth, delivered in a period of investment, including:R&D investment of $194.6 million, in line with guidance, with a focus on late-stage assets.Expanded global supply chain and product delivery infrastructure, including acquisitions of ARTMS, Inc. and IsoTherapeutics Group, LLC, and expansion of Telix Manufacturing Solutions' Brussels South facility, resulting in an incremental increase of $15.8 million in manufacturing and distribution investment.Adjusted EBITDA of $99.3 million, up by 70%, demonstrating strong underlying growth3.Telix continued to deliver on its growth strategy. The Company's key achievements, aligned to its strategic pillars:Grow precision medicine: Prepared for launch of three new products TLX007-CDx (Gozellix®), TLX101-CDx (Pixclara®) and TLX250-CDx (Zircaix®)4 in 2025 while continuing to increase sales and market share for Illuccix®.Deliver late-stage therapeutics: Expanded ProstACT GLOBAL Phase 3 prostate cancer therapy trial recruitment in the U.S. and continued to advance therapeutic trials for the brain and kidney cancer programs.Build next generation pipeline: Delivered clinical proof-of-concept for first alpha therapy candidate in prostate cancer (TLX592) and added depth to urology franchise with acquisition of FAP5-targeting theranostic.Expand global delivery infrastructure: Completed acquisitions of ARTMS, IsoTherapeutics and RLS (USA), Inc. (RLS)6 and expanded Brussels South facility, in preparation to commence GMP7 production in 2025.

MELBOURNE, Australia, Feb. 12, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the Marketing Authorization Application (MAA) for its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection).

Illuccix is indicated in the UK for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, using PET. PSMA-PET imaging[2] represents a major advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT[3] scan) as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines highlight the superior accuracy of PSMA-PET for the staging of primary disease and evaluation of BCR/biochemical persistence (BCP)[4].

MELBOURNE, Australia, Feb. 13, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the Marketing Authorization Application (MAA) for its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection).

MELBOURNE, Australia and INDIANAPOLIS, Jan. 31, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces it has completed the acquisition from antibody engineering company ImaginAb, Inc. (ImaginAb). The acquisition includes a pipeline of next-generation therapeutic candidates, a proprietary novel biologics technology platform, and a protein engineering and discovery research facility to enhance existing innovation capabilities[1].

MELBOURNE, Australia and INDIANAPOLIS, Jan. 28, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces it has completed the acquisition of RLS (USA) Inc. (RLS; RLS Radiopharmacies), America's only Joint Commission-accredited radiopharmacy network distributing PET[1], SPECT[2] and therapeutic radiopharmaceuticals. 

The acquisition immediately enhances Telix's presence in the United States (U.S.), with a network of over 30 radiopharmacies[3] dispensing radiopharmaceuticals manufactured by Telix and other companies, while bringing a team of highly-skilled and multi-disciplinary radiopharmaceutical professionals into the Company.