Telix Pharmaceuticals Ltd ADR Stock Price, News & Analysis

Telix Pharmaceuticals (ASX/Nasdaq: TLX) announces an upcoming investor webinar focused on its urologic oncology portfolio. The educational session will feature presentations from three global experts discussing the company's late-stage and next-generation radiotherapeutic candidates.

The panel includes: Dr. Neeraj Agarwal presenting on the ProstACT Global Phase 3 trial of TLX591 for prostate cancer; Dr. Eric Jonasch discussing the STARLITE studies of TLX250 in combination with immunotherapy for clear cell renal cell carcinoma; and Dr. Rodney Hicks covering TLX592 and targeted alpha therapies in prostate cancer treatment.

The 1.5-hour webinar is scheduled for Tuesday, March 11, 2025, at 5:30 PM EDT (Wednesday, March 12, 8:30 AM AEDT).

Telix Pharmaceuticals (ASX/Nasdaq: TLX) announces FDA acceptance of Biologics License Application (BLA) for TLX250-CDx (Zircaix®), their kidney cancer PET imaging agent, with Priority Review status and PDUFA date of August 27, 2025.

TLX250-CDx is positioned to become the first commercially available imaging agent for accurate, non-invasive diagnosis of clear cell renal cell carcinoma (ccRCC). The technology targets carbonic anhydrase IX (CAIX), expressed on 95% of ccRCC cells.

The BLA submission is supported by the Phase 3 ZIRCON study results, showing 86% sensitivity, 87% specificity, and 93% positive predictive value for ccRCC detection. The study results, published in The Lancet Oncology (September 2024), highlight the product's potential to revolutionize kidney cancer management similar to PSMA-PET/CT's impact on prostate cancer diagnostics.

Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) announces that the Biogenix Molecular Research Center in Miami is now recruiting and dosing patients in the ProstACT Global Phase 3 trial of TLX591 for advanced prostate cancer. The center has successfully administered two doses of TLX591 to a local patient and continues recruitment in the Miami area as part of a wider U.S. rollout.

The trial investigates TLX591 as first-line and second-line therapy in metastatic castration resistant prostate cancer (mCRPC) in combination with standard of care. It features a patient-friendly dosing regimen of two doses 14 days apart and integrates with real-world standards of care including abiraterone, enzalutamide, or docetaxel chemotherapy.

ProstACT Global is the first trial to combine a PSMA-targeted radio antibody-drug conjugate (rADC) therapy with androgen receptor pathway inhibition and docetaxel sensitization, differentiating it from commercially available PSMA-targeted monotherapies and other radioligand therapies.

Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) reported strong financial results for FY2024, with total revenue reaching $783.2 million, up 56% from 2023, primarily driven by Illuccix® sales. The company achieved an Adjusted EBITDA of $99.3 million, representing a 70% increase.

Key investments included $194.6 million in R&D focusing on late-stage assets, and strategic acquisitions of ARTMS, IsoTherapeutics Group, and RLS. The company expanded its global supply chain through its Brussels South facility enhancement, resulting in a $15.8 million increase in manufacturing investment.

Looking ahead, Telix provided FY2025 revenue guidance of $1.18-1.23 billion and plans to launch three new products: TLX007-CDx (Gozellix®), TLX101-CDx (Pixclara®), and TLX250-CDx (Zircaix®). R&D expenditure is expected to increase by 20-25% compared to FY2024.

Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) announces four presentations at ASCO GU 2025 in San Francisco, showcasing their therapeutic urologic pipeline. The presentations include preliminary data from the CUPID study of TLX592, demonstrating clinical proof-of-concept for their alpha therapy candidate for prostate cancer.

The company will present updates on ProstACT GLOBAL, their Phase 3 trial evaluating TLX591 in PSMA-positive mCRPC patients. Additionally, updates will be provided on the STARLITE-1 and STARLITE-2 trials, investigating TLX250 in combination with immunotherapy for kidney cancer treatment. TLX250 is positioned to be the first CAIX-targeting rADC to market and is advancing toward a pivotal trial in clear cell renal cell carcinoma.

Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its prostate cancer PET imaging agent Illuccix®. The product is approved for detecting and localizing PSMA-positive lesions in adults with prostate cancer.

PSMA-PET imaging has become the standard of care for prostate cancer management, replacing conventional imaging methods. The approval addresses critical supply shortages in the UK and Europe, where increasing demand has caused delays in patient care.

A key advantage of Illuccix is its local production capability using a gallium-68 generator, requiring minimal equipment and time. The product will be distributed in the UK through Telix's exclusive partner, Xiel , improving access to PSMA-PET imaging across metropolitan and non-metropolitan locations.

Telix Pharmaceuticals has completed the acquisition of ImaginAb, securing next-generation therapeutic candidates and a proprietary biologics technology platform. The transaction, valued at US$45 million upfront, includes a pipeline of drug candidates targeting cancer markers DLL3 and integrin αvβ6, along with a research facility in Los Angeles.

The deal structure comprises US$10 million in cash, US$31 million in equity (2,053,311 Telix shares at AU$24.3745), and a deferred payment of up to US$4 million. Additional milestone payments of up to US$185 million may be paid upon achieving specific development and commercial targets. The acquisition brings advanced protein engineering capabilities and a specialized research team to Telix's existing operations.

The technology platform features engineered antibody formats enabling precise cancer targeting with radiation, characterized by rapid tumor uptake and blood clearance. This acquisition enhances Telix's ability to develop next-generation theranostic radiopharmaceuticals.

Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) has completed the acquisition of RLS (USA) Inc., America's only Joint Commission-accredited radiopharmacy network. The acquisition, valued at US$230 million upfront with potential additional US$20 million in milestone-based payments, includes a network of over 30 radiopharmacies and more than 100,000 square ft of licensed expansion space.

RLS will operate as a standalone business within Telix Manufacturing Solutions (TMS), joining other key brands like ARTMS, IsoTherapeutics, and Optimal Tracers. The integration enhances Telix's U.S. presence and distribution capabilities, enabling in-house cyclotron manufacturing using ARTMS QUANTM Irradiation System™ technology for radiometal production.

ImaginAb has agreed to sell its next-generation therapeutic candidates, proprietary biologics technology platform, and protein engineering facility to Telix Pharmaceuticals (ASX: TLX; Nasdaq: TXL). Post-transaction, ImaginAb will focus on developing its CD8 ImmunoPET imaging candidate, currently in Phase 2 clinical trials and licensed by multiple pharmaceutical companies for immunotherapy imaging trials. The company will also continue developing its Phase 2 prostate cancer imaging agent.

The transaction validates ImaginAb's minibody platform technology, which will enable Telix to explore new disease areas with radiotherapeutic technology. The CD8 platform development will continue, with multiple pharmaceutical companies already incorporating the technology in their immuno-oncology clinical trials. Jefferies and Stifel, Nicolaus & Company served as financial advisors for the transaction.