Telix Pharmaceuticals Ltd ADR Stock Price, News & Analysis

Telix Pharmaceuticals (ASX/NASDAQ: TLX) has published promising results for its FAP-targeting therapy candidate TLX400 in the Thyroid journal. The study, involving 73 heavily pre-treated patients with radioiodine-resistant (RAI-R) thyroid cancer, demonstrated encouraging efficacy with median progression-free survival of 29 months and overall survival of 32 months.

The treatment showed a 50% partial response rate with manageable adverse events, primarily hematotoxicity. TLX400's novel structure enables prolonged tumor retention while minimizing off-target uptake, potentially offering advantages over current tyrosine kinase inhibitors (TKIs) like sorafenib and lenvatinib, which can have significant side effects.

Telix Pharmaceuticals has received marketing authorization in France for Illuccix, its prostate cancer PET imaging agent. The approval by ANSM enables French healthcare facilities to access this PSMA-PET imaging technology for prostate cancer detection and management.

The approval covers three key clinical applications:

• Primary staging of high-risk prostate cancer patients
• Detection of recurrent cancer in patients with rising PSA levels
• Identification of patients suitable for PSMA-targeted therapy

Telix has partnered with IRE ELiT for marketing and promotion in France, where prostate cancer affects over 57,000 new cases annually. The technology offers superior accuracy compared to conventional imaging methods and allows on-site preparation of PSMA-PET scans, improving accessibility and reducing diagnosis delays.

Telix Pharmaceuticals (ASX/NASDAQ: TLX) reported strong Q1 2025 performance with unaudited revenue of $186 million, up 62% year-over-year and 31% quarter-over-quarter. This includes:

- $151 million from global Illuccix® sales (35% YOY increase)
- $33 million from RLS Radiopharmacies acquisition

The company reaffirmed FY 2025 revenue guidance of $770-800 million. Key developments include:
- FDA approval of Gozellix®, a next-generation PSMA-PET imaging agent
- Positive preliminary results from IPAX-Linz Phase 2 trial for brain cancer therapy
- FDA acceptance of TLX250-CDx BLA with Priority Review
- GMP accreditation for TMS Brussels South facility

The company continues to expand globally with Illuccix® receiving approvals in multiple European markets, UK, and Brazil.

Telix Pharmaceuticals (ASX/NASDAQ: TLX) has announced promising preliminary results from its Phase 2 IPAX-Linz study of TLX101 therapy for recurrent high-grade glioma. The study, combining TLX101 with external beam radiation therapy (EBRT), demonstrated a median overall survival of 12.4 months from treatment initiation, or 32.2 months from initial diagnosis.

The trial included eight patients, with treatment well-tolerated and no serious adverse events reported. Five patients had MGMT unmethylated tumors, typically associated with poor prognosis. The results corroborated the positive efficacy signal from the earlier IPAX-1 study, which showed 13 months median survival from treatment.

Telix is advancing its TLX101 development program with ongoing IPAX-2 study in front-line glioblastoma. The company has submitted for ethics approval a registration-enabling study, planning to begin patient enrollment at Australian sites in H2 2025, with U.S. sites expansion following an IND application in H1 2025.

Telix Pharmaceuticals (ASX/NASDAQ: TLX) has selected Cardinal Health (NYSE: CAH) as a commercial radiopharmaceutical distributor for Gozellix®, its FDA-approved next-generation PSMA-PET imaging agent for prostate cancer in the United States.

Cardinal Health will deploy Telix's ARTMS QUANTM Irradiation System® (QIS®) cyclotron technology for standardized, high-efficiency production of gallium-68 used with Gozellix®. The distribution agreement enables multi-Curie local production and broader availability across U.S. locations, with commercial launch planned for H1 2025.

Cardinal Health will serve as a strategic radiopharmacy distributor alongside Telix's in-house radiopharmacy network, expanding their existing partnership which includes distribution of Illuccix® and Zircaix®.

Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) has appointed Dr. Paul Schaffer as its new Chief Technology Officer (CTO), effective April 07, 2025. Dr. Schaffer joins from ARTMS Inc., where he served as CTO for seven years, and TRIUMF, Canada's particle accelerator research centre, where he was Director of Life Science since 2012.

In his new Vancouver-based role, Dr. Schaffer will oversee Telix's technological advancement in radiopharmaceutical research, development, and clinical applications. His responsibilities will encompass chemistry, physics, artificial intelligence, dosimetry, and data analytics, working alongside Chief Scientist Dr. Michael Wheatcroft's team.

Dr. Schaffer is notably recognized for developing the ARTMS QUANTM Irradiation System® (QIS®) for large-scale isotope production, which was later acquired by Telix in 2024, and for transforming TRIUMF's Life Sciences program, including the design of a multi-cyclotron radiochemistry facility.

Telix Pharmaceuticals (ASX/NASDAQ: TLX) has appointed Anne Whitaker as a Non-Executive Director, effective April 7, 2025. Whitaker brings over 30 years of global corporate experience in pharmaceutical, biotech, and specialty pharmaceutical sectors, including clinical research and manufacturing organizations.

Currently serving as a Non-Executive Director at Icon PLC (NASDAQ: ICLR) and Chair at QurAlis , Whitaker's most recent executive role was as Chair and CEO of Aerami Therapeutics Holdings. Her career includes senior leadership positions at GlaxoSmithKline, Sanofi, and Bausch Health. She holds a Bachelor of Science in Chemistry and Business from the University of North Alabama.

Telix Pharmaceuticals (ASX/NASDAQ: TLX) has announced the dosing of the first patient in its Phase 1 ZOLAR trial of TLX300-CDx at the Melbourne Theranostic Innovation Centre. The trial evaluates 89Zr-olaratumab in patients with advanced, metastatic soft tissue sarcoma (STS).

The first-in-human study aims to assess safety, pharmacokinetics, biodistribution, and optimal dosing of TLX300-CDx. The diagnostic agent targets PDGFRα, a protein commonly overexpressed in STS. The trial's findings will guide the selection of therapeutic radionuclides for future treatment applications.

Telix holds exclusive worldwide rights to develop radiolabelled forms of olaratumab, originally developed by Eli Lilly. The company plans to develop a targeted radionuclide therapy for STS patients, addressing the current challenges in treating metastatic disease that typically responds poorly to chemotherapy.

Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) has received FDA approval for Gozellix®, a next-generation PSMA-PET imaging agent for prostate cancer. The product is designed for PET scanning of PSMA positive lesions in men with suspected metastasis or recurrence.

Key features of Gozellix® include:

• Extended shelf life up to 6 hours
• Wider distribution radius compared to existing products
• Enhanced efficiency and scheduling flexibility for scanning clinics
• Expected full reimbursement with reduced/no patient co-insurance

The product will be available alongside Telix's first-generation product Illuccix®, targeting the 3.4 million men living with prostate cancer in the U.S. who currently have access to PSMA-PET imaging. The approval aims to improve accessibility to precision medicine scanning, particularly in underserved populations.