Highlights

• The FDA aligned with Telix on advancing Part 2 of the ProstACT Global Phase 3 trial.

• The Phase 3 study continues enrolling patients across multiple international markets.

• Telix shares remain down around 30% over the past year despite continued clinical progress.

Introduction

Telix Pharmaceuticals Ltd (ASX:TLX) remained in focus after announcing a key regulatory milestone for its lead prostate cancer therapeutic programme. Although the stock has declined approximately 30.25% over the past year and slipped 2.76% during Thursday's trading session, investors continue monitoring progress across the company's late-stage radiopharmaceutical pipeline.

On 2 July, Telix announced that it had achieved alignment with the U.S. Food and Drug Administration (FDA) on advancing Part 2 of the ProstACT Global Phase 3 trial evaluating TLX591-Tx for metastatic castration-resistant prostate cancer.

FDA Supports Advancement of Global Phase 3 Study

Telix reported a successful Type B meeting with the FDA, during which the regulator confirmed that Part 1 safety and dosimetry data support progression into Part 2 of the ProstACT Global study in the United States.

The FDA also agreed with the proposed clinical protocol, statistical analysis plan and ongoing safety monitoring framework for the randomized Phase 3 study.

Under Part 2, TLX591-Tx will be administered in two doses, 14 days apart, alongside one of three standard-of-care therapies:

• Abiraterone

• Enzalutamide

• Docetaxel

The company stated that patient recruitment continues in countries where regulatory approvals have already been obtained.

Study Continues Expanding Internationally

The ProstACT Global study is designed as an international multicentre Phase 3 trial enrolling approximately 490 patients following completion of its initial safety stage. The trial is already recruiting patients in Australia, New Zealand, Canada, Türkiye and the United Kingdom, while regulatory approvals have also been secured to commence enrolment in China, Singapore and South Korea.

Initiation of Part 2 in the United States remains subject to the FDA's review of an Investigational New Drug (IND) amendment, which Telix plans to submit following the regulatory discussions.

TLX591-Tx Remains a Key Pipeline Asset

TLX591-Tx is an investigational radiopharmaceutical therapy targeting metastatic castration-resistant prostate cancer (mCRPC).

According to Telix, the antibody-based therapy has demonstrated a differentiated pharmacological profile, including hepatic excretion rather than kidney excretion, while also showing minimal salivary and lacrimal gland uptake in previous studies. These characteristics are intended to reduce some of the adverse effects commonly associated with certain PSMA-targeted radioligand therapies.

The therapy forms part of Telix's broader oncology pipeline, which also includes late-stage programmes targeting glioblastoma and kidney cancer.

Why Investors Continue Monitoring Telix

Although Telix shares remain approximately 30% below their level a year ago, the company continues advancing multiple late-stage clinical programmes.

Investors are expected to closely monitor:

• FDA review of the IND amendment

• Expansion of U.S. patient enrolment

• Progress of the ProstACT Global Phase 3 study

• Regulatory developments across additional jurisdictions

• Advancement of the broader oncology pipeline

Clinical milestones remain important events for companies developing radiopharmaceutical therapies, particularly those progressing through pivotal-stage studies.

Conclusion

Telix Pharmaceuticals Ltd (ASX:TLX) continues advancing its oncology pipeline despite its shares remaining around 30% lower over the past year. The company's latest announcement confirmed FDA alignment to progress Part 2 of the ProstACT Global Phase 3 study, marking an important regulatory step for TLX591-Tx in metastatic prostate cancer.

As the company prepares regulatory submissions and expands patient recruitment internationally, investors are expected to monitor further clinical, regulatory and operational developments across its radiopharmaceutical portfolio.