Telix Pharmaceuticals updates investors as first patient is dosed in Phase 3 prostate cancer trial

The Telix Pharmaceuticals Ltd (ASX: TLX) share price is in focus today after the company announced the first patient has been dosed in Part 2 of its ProstACT Global Phase 3 trial for treating advanced prostate cancer. The company also confirmed plans for a key Part 1 data readout and further regulatory engagement.

What did Telix Pharmaceuticals report?

• First patient dosed in ProstACT Global Phase 3 trial (randomised treatment expansion, Part 2)
• Part 2 to enrol about 490 patients across Australia, New Zealand, and Canada
• Approval granted to also commence trial sites in China, Japan, Singapore, South Korea, Türkiye, and the UK
• Part 1 data to be submitted to the US FDA, aligning public results disclosure
• No newly reported revenue or financial figures in this update

What else do investors need to know?

ProstACT Global is the first Phase 3 trial to test a PSMA-targeted radio antibody drug combined with standard-of-care therapies versus standard-of-care alone for metastatic castration-resistant prostate cancer. The global rollout is accelerating, with applications underway to expand into European sites.

The company highlights potential patient benefits, including different targeting and fewer side effects such as kidney toxicity and dry mouth compared to current radioligand therapies. The clinical trial’s expansion signals Telix’s growing international ambition, including approaching both US and European regulators for further approvals.

What did Telix Pharmaceuticals management say?

Dr. David N. Cade, Group Chief Medical Officer, said:

Dosing the first patient into Part 2 of the randomized treatment expansion of ProstACT Global trial is a significant milestone for Telix’s late-stage prostate cancer therapeutics pipeline. We look forward to presenting the preliminary data from Part 1 of the study to the FDA and EMA in the coming months.

What’s next for Telix Pharmaceuticals?

Telix plans to submit Part 1 data to the FDA to enable US site participation in the clinical trial and expects to share preliminary results publicly in line with its regulatory strategy. In parallel, the company is seeking further expansion into Europe and other international markets.

With global recruitment underway and regulatory milestones ahead, Telix aims to strengthen its late-stage oncology pipeline and broaden its impact for patients with advanced prostate cancer.

Telix Pharmaceuticals share price snapshot

Over the past 12 months, Telix Pharmaceuticals shares have declined 40%, trailing the S&P/ASX 200 Index (ASX: XJO) which has risen 3% over the same period.

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The post Telix Pharmaceuticals updates investors as first patient is dosed in Phase 3 prostate cancer trial appeared first on The Motley Fool Australia.

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Motley Fool contributor Laura Stewart has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has positions in and has recommended Telix Pharmaceuticals. The Motley Fool Australia has recommended Telix Pharmaceuticals. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips. This article was prepared with the assistance of Large Language Model (LLM) tools for the initial summary of the company announcement. Any content assisted by AI is subject to our robust human-in-the-loop quality control framework, involving thorough review, substantial editing, and fact-checking by our experienced writers and editors holding appropriate credentials. The Motley Fool Australia stands behind the work of our editorial team and takes ultimate responsibility for the content published by The Motley Fool Australia.