Telix Pharmaceuticals Limited - American Depositary Shares (TLX)

Glancy Prongay & Murray LLP, a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Telix Pharmaceuticals Limited (“Telix” or the “Company”) (NASDAQ: TLX) investors concerning the Company’s possible violations of the federal securities laws.

Law Offices of Howard G. Smith announces an investigation on behalf of Telix Pharmaceuticals Limited (“Telix” or the “Company”) (NASDAQ: TLX) investors concerning the Company’s possible violations of federal securities laws.

The Law Offices of Frank R. Cruz announces an investigation of Telix Pharmaceuticals Limited (“Telix” or the “Company”) (NASDAQ: TLX) on behalf of investors concerning the Company’s possible violations of federal securities laws.

MELBOURNE, Australia and INDIANAPOLIS, July 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today provides an update on its commercial and operational performance for the quarter ended 30 June 2025 (Q2 2025). All figures are in USD unless stated otherwise.

MELBOURNE, Australia and INDIANAPOLIS, July 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that its next-generation PSMA1 PET2 imaging agent, Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) code by the U.S. Centers for Medicare & Medicaid Services (CMS).

MELBOURNE, Australia and INDIANAPOLIS, June 23, 2025 (GLOBE NEWSWIRE) -- 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 a label expansion for Illuccix® (kit for the preparation of gallium Ga-68 gozetotide, for injection) to include patient selection for radioligand therapy (RLT) in the pre-taxane setting.

MELBOURNE, Australia and INDIANAPOLIS, June 20, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces it has launched a novel PET1 radiochemistry solution based on 18F-aluminium fluoride (AlF), named AlFluor™.

MELBOURNE, Australia and INDIANAPOLIS, June 20, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces five abstract presentations and two satellite symposia featuring its developmental theranostic programs and commercial products at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2025 Annual Meeting being held in New Orleans, Louisiana (U.S.) from June 21 – 24.

MELBOURNE, Australia and INDIANAPOLIS, June 11, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces that its next-generation PSMA-PET imaging1 agent for prostate cancer, Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), is now commercially available nationally in the United States (U.S.).

MELBOURNE, Australia and INDIANAPOLIS, June 03, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) provides further details on the agenda for the Company’s Investor Day to be held on Wednesday, June 11, 2025, at The Yale Club in New York City, from 8.30am ET (10.30pm AEST) to 12.00pm ET.

MELBOURNE, Australia and INDIANAPOLIS, May 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces it will host an Investor Day on Wednesday, June 11, 2025, in person, in New York City, from 8:30am ET to 12.00pm ET.

MELBOURNE, Australia and INDIANAPOLIS, May 08, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that its Fibroblast Activation Protein (FAP)-targeting therapy candidate, TLX400, has been published in Thyroid, the official journal of the American Thyroid Association. The candidate demonstrated an encouraging safety profile and efficacy in aggressive, radioiodine-resistant (RAI-R) thyroid cancer1.

New approval provides French hospitals and clinics with access to a proven PSMA-PET imaging agent

MELBOURNE, Australia and INDIANAPOLIS, April 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today provides an update on its commercial and operational performance for the quarter ended 31 March 2025 (Q1 2025). All figures are in $US unless stated otherwise.

MELBOURNE, Australia and INDIANAPOLIS, April 16, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces preliminary results from the Phase 2 IPAX-Linz study of TLX101 (131I-iodofalan1) in recurrent high-grade glioma (brain cancer), substantiating the patient benefit seen in the IPAX-1 study2.

MELBOURNE, Australia and INDIANAPOLIS, April 08, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that it has selected Cardinal Health, Inc. (NYSE: CAH, Cardinal Health) as one of its commercial radiopharmaceutical distributors to supply finished unit doses of Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s next-generation PSMA-PET imaging1 agent for prostate cancer in the United States (U.S.).

MELBOURNE, Australia and INDIANAPOLIS, April 07, 2025 (GLOBE NEWSWIRE) -- 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.

MELBOURNE, Australia and INDIANAPOLIS, April 04, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces the appointment of Anne Whitaker as a Non-Executive Director (NED) based in the United States, effective 7 April 20251.

MELBOURNE, Australia, April 02, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; NASDAQ: TLX, Telix, the Company) today announces that a first patient has been dosed in the Phase 1 ZOLAR1 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.

BURNABY, British Columbia, April 01, 2025 (GLOBE NEWSWIRE) -- Telix ARTMS, Inc. (ARTMS), a global leader in radioisotope production technologies, is pleased to announce that the drug master file (DMF)1 for gallium-68 production using its QUANTM Irradiation System® (QIS®) cyclotron technology has been referenced for the first time with a United States (U.S.) Food and Drug Administration (FDA) approved product, with Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection).

MELBOURNE, Australia and INDIANAPOLIS, March 21, 2025 (GLOBE NEWSWIRE) -- 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 imaging1 agent for prostate cancer.

MELBOURNE, Australia and PORTO ALEGRE, Brazil, March 18, 2025 (GLOBE NEWSWIRE) -- 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-PET1 prostate cancer imaging agent to receive full regulatory approval in Brazil.

MELBOURNE, Australia and INDIANAPOLIS, March 13, 2025 (GLOBE NEWSWIRE) -- 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.

MELBOURNE, Australia and INDIANAPOLIS, March 04, 2025 (GLOBE NEWSWIRE) -- 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.

MELBOURNE, Australia and INDIANAPOLIS, Feb. 26, 2025 (GLOBE NEWSWIRE) -- 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 PET1 imaging agent TLX250-CDx (Zircaix®2, 89Zr-DFO-girentuximab), granted a Priority Review and provided a PDUFA3 date of 27 August 2025, paving the way for a U.S. commercial launch in 2025.