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For those unlucky enough to have received a testicular castration to treat prostate cancer, only for it to come back, Clarity Pharmaceuticals’ (ASX:CU6) news on Wednesday morning could offer crucial moral support.

For those patients (who have also already received first-stage less severe treatment options,) Clarity’s imaging agent has been approved by the FDA for a fast-track study on that cohort.

While Clarity doesn’t necessarily make drugs that actually attempt to ‘cure’ or mitigate cancer – rather image them in the human body using PET scans – those same drugs can have therapeutic effects on actual cancers too, given their radioactive nature.

Clarity’s ultimate value proposition is its imaging agent is better than existing dominant products, meaning more cancerous growths can be revealed in a PET scan that other imaging agents might not enable for detection.

That said, if the company can get rid of cancers too, well hey, even better.

Clarity’s fast-track approval comes on the back of data from a dose escalation study that showed no obvious toxic effects in patients with prostate cancer.

“Receiving three FTDs for the one molecule, SAR-bisPSMA, within the last six months is an incredible achievement for Clarity,” CU6 chairman Dr Alan Taylor explained.

β€œThe dual-targeted bisPSMA molecule was developed at the benchtop of Australian science with the intent of overcoming the shortfalls of the current generation of PSMA-targeting products.

“It was optimised with two PSMA ligands, which increases not only the amount of product in the lesions but also how long the product is retained in the lesions over time, making it an ideal candidate for both diagnosis and therapy.”

It’s the latest win for the company which has in recent years surged to record highs and plummeted back down to a perhaps more reasonable valuation.

The ASX-listed biotech stock is still well above where it was three years ago, too – another winner in what is proving to be a bit of a boom cycle for a swathe of Aussie biotech stocks from mid-late 2024.

CU6 last traded at $3.43/sh.

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