Telix Pharmaceuticals Ltd (ASX: TLX) shares are falling on Monday.
In morning trade, the ASX biotech stock is down 1% to $14.65.
What's going on with Telix shares?
Telix shares are falling today despite the announcement from the radiopharmaceuticals company relating to its ProstACT Global Phase 3 study.
The company notes that ProstACT Global study is an international, multi-centre trial in two parts. Part 1 is a safety and dosimetry lead-in with 30 patients, whereas Part 2 is a 2:1 randomised global expansion with an overall target enrolment of approximately 490 patients.
The study is evaluating its lead prostate cancer therapy candidate TLX591 in patients with metastatic castration resistant prostate cancer (mCRPC).
According to the release, the first patient was dosed at the Australian Prostate Centre (APC) in Melbourne, Australia.
Management is optimistic about the future of TLX591. It highlights that it is the first phase 3 trial to combine a PSMA targeted radio antibody drug conjugate (rADC) therapy administered together with the standard of care versus the standard of care alone.
What's next?
Telix has previously agreed with US Food and Drug Administration (FDA) that it will submit Part 1 data to enable clearance to expand Part 2 of the trial to U.S. sites.
A public disclosure of preliminary results from Part 1 of the study will be aligned to engagement with the FDA.
The study is also approved to commence in China, Japan, Singapore, South Korea, Turkey, and the United Kingdom. In addition, as part of the further global expansion of the trial, the company will file a clinical trial application (CTA) with the European Medicines Agency (EMA) to enable expansion into EU sites.
Commenting on the news, Telix's group chief medical officer, Dr David N Cade, 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.
Should you invest?
While it has not yet responded to today's news, the team at Bell Potter is bullish on Telix shares.
It currently has a buy rating and $23.00 price target on them, which implies potential upside of over 50% for investors based on its last close price.
