Telix Pharmaceuticals Ltd ADR Stock Price, News & Analysis

The FDA has approved a label expansion for Telix Pharmaceuticals' (TLX) Illuccix, enabling its use for patient selection in radioligand therapy (RLT) in the pre-taxane setting. This expansion aligns with the recent FDA approval of Pluvicto for earlier use in metastatic castration-resistant prostate cancer patients. The clinical utilization of Illuccix is expected to increase by approximately 20,000 scans annually due to this development. Illuccix is used for PET imaging of PSMA-positive lesions in prostate cancer patients, helping identify those most likely to respond to PSMA-targeted therapy earlier in their treatment journey. The diagnostic tool has demonstrated safety in clinical studies involving over 1,900 patients, with minimal adverse reactions reported.

Telix Pharmaceuticals has launched AlFluor™, a novel PET radiochemistry platform enabling flexible radiolabeling of PSMA with either AlF or gallium-68. The platform combines 18F imaging benefits with 68Ga kit-based workflow convenience, supporting both centralized cyclotron manufacturing and distributed kit production. Telix has partnered with University Hospital Ghent for [18F]AlF-PSMA-11, including exclusive access to Phase 3 trial data involving 96 prostate cancer patients. The trial showed diagnostic performance comparable to commercial 68Ga-labeled PSMA-11 agents, with high specificity for metastatic detection. The technology can potentially be used with ligands targeting NETs and FAP, along with other imaging agents under development.

Telix Pharmaceuticals (ASX/NASDAQ: TLX) announces its significant presence at the SNMMI 2025 Annual Meeting in New Orleans, featuring five abstract presentations and two satellite symposia. Key highlights include presentations on the ProstACT Global Phase 3 study of TLX591 for advanced prostate cancer, preclinical data on TLX252 alpha therapy for CAIX-expressing tumors, and clinical study data on Illuccix's impact on decision-making. The company will showcase its extensive theranostic portfolio at booth #408, covering various oncology areas including urologic, neuro-oncology, musculoskeletal, and hematologic cancers. Two sponsored symposia will focus on CAIX-PET imaging in renal cancer and Illuccix PSMA-PET imaging in prostate cancer, featuring presentations from leading medical experts.

Telix Pharmaceuticals has launched Gozellix, its next-generation PSMA-PET imaging agent for prostate cancer, across the United States. The FDA-approved imaging agent, available through major distribution partners, is designed for PET scanning of PSMA positive lesions in men with suspected metastatic prostate cancer or biochemical recurrence. Gozellix demonstrates 90% specificity and can detect micrometastases at PSA levels as low as 0.02 ng/mL. The product features an extended "hot" shelf-life of up to six hours, enabling broader geographical reach and improved scheduling flexibility. This advancement could potentially serve the previously underserved portion of the 3.4 million U.S. men with prostate cancer, reaching up to 20% more PET cameras than current alternatives. The agent can be produced either centrally via cyclotron or locally with a gallium generator, offering enhanced production flexibility.

Telix Pharmaceuticals (ASX/NASDAQ: TLX) announces its upcoming Investor Day on June 11, 2025, at The Yale Club in New York City. The event will showcase growth opportunities across Telix's commercial and clinical portfolio of precision medicine and therapeutic radiopharmaceuticals. Three distinguished key opinion leaders will present: Dr. Oliver Sartor, a prostate cancer expert discussing TLX591; Dr. John de Groot, a neuro-oncology specialist presenting on TLX101 for glioblastoma therapy; and Dr. Joseph Osborne, Chief of Molecular Imaging at Weill Cornell Medicine, discussing renal cancer imaging with TLX250-CDx (Zircaix). The event runs from 8:30 AM to 12:00 PM ET and is open to institutional investors and analysts with required advance registration.

Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) has announced an upcoming Investor Day scheduled for June 11, 2025, in New York City. The event will run from 8:30 AM to 12:00 PM ET and will focus on growth opportunities across Telix's commercial and clinical portfolio of precision medicine and therapeutic radiopharmaceuticals.

Key presenters will include CEO Dr. Christian Behrenbruch, CMO Dr. David N. Cade, CEO Therapeutics Richard Valeix, and CEO Precision Medicine Kevin Richardson. Key Opinion Leaders will also share insights on Telix's theranostic candidates. The event is exclusively for qualified institutional investors and analysts, with advance registration required via email.

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.