One ASX 200 stock is making waves on the Australian share market today.
That stock is Clarity Pharmaceuticals Ltd (ASX: CU6), which has seen its shares surge 10% to $2.36 on the back of some big news.
What did this ASX 200 stock announce?
This morning, the clinical-stage radiopharmaceutical company announced that it has imaged the first patient in its pivotal Phase III AMPLIFY trial for 64Cu-SAR-bisPSMA. It is a next-generation PET/CT diagnostic tool designed to detect prostate cancer recurrence earlier and more accurately than existing options.
The AMPLIFY trial is a major event for Clarity, which is aiming to gather enough data to support a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). This is an important step toward commercialisation.
According to the release, the trial will enrol around 220 patients across the U.S. and Australia, with the first participant now imaged at XCancer in Omaha, Nebraska.
Dr Luke Nordquist, Urologic Medical Oncologist and CEO of XCancer, spoke positively about the potential of Clarity's technology. He said:
We are thrilled to recruit the first participant in the AMPLIFY trial and to image them just over a week after study initiation. 64Cu-SAR-bisPSMA could become a best-in-class diagnostic prostate-specific membrane antigen (PSMA) agent, and we are honoured to be part of this registrational trial that intends to gather sufficient data for a New Drug Application (NDA) and a potential subsequent commercialisation of this next-generation product.
'Excited'
This sentiment was echoed by the ASX 200 stock's executive chair, Dr Alan Taylor. He adds:
We are excited to have imaged the first patient in the AMPLIFY trial and look forward to further progressing recruitment and opening clinical sites across the United States (US) and Australia, providing access to 64Cu-SAR-bisPSMA in both countries as part of this trial.
We have built a robust supply of copper-64 with a wide network of product manufacturers in preparation for our two Phase III trials, AMPLIFY in BCR and CLARIFY in pre-prostatectomy, and potential commercialisation. As such, we are ideally positioned to build on the clinical advantages of 64Cu-SAR-bisPSMA.
Dr Taylor also notes that prostate cancer cases are rising each year, which highlights the importance of its technology. He said:
With prostate cancer cases rising each year, we're aiming to overcome the limitations of current diagnostics and bring earlier, more precise detection to patients — whether they're in a major city or a regional area.
The company points out that the American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease.
This makes prostate cancer the second most common cancer in men globally, which means the addressable market for a breakthrough diagnostic like 64Cu-SAR-bisPSMA is huge. This goes some way to explaining why the ASX 200 stock is surging on Thursday.
