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Clarity Pharmaceuticals Ltd. ( (AU:CU6) ) just unveiled an announcement.
Clarity Pharmaceuticals has secured positive guidance from the US Food and Drug Administration to commence a pivotal Phase III registrational trial of its Cu-64 SARTATE PET/CT diagnostic agent in patients with neuroendocrine tumours, with recruitment expected to begin in 2026. The single-arm, open-label trial of around 70 patients aims to generate the data needed to support a US approval filing, building on Phase I and Phase II results showing Cu-64 SARTATE to be safe, well tolerated and substantially more effective at lesion detection, particularly in the liver, than the current standard-of-care Ga-68 DOTATATE. The move marks Clarity’s third registrational trial and underlines the company’s strategy to challenge existing radiopharmaceutical standards with its Targeted Copper Theranostic products, potentially strengthening its position in the rapidly evolving oncology imaging market and offering clinicians improved tools for diagnosing and managing neuroendocrine tumours.
The most recent analyst rating on (AU:CU6) stock is a Buy with a A$5.00 price target. To see the full list of analyst forecasts on Clarity Pharmaceuticals Ltd. stock, see the AU:CU6 Stock Forecast page.
More about Clarity Pharmaceuticals Ltd.
Clarity Pharmaceuticals Ltd (ASX: CU6) is a clinical-stage radiopharmaceutical company focused on developing innovative Targeted Copper Theranostics based on its SAR Technology Platform for the diagnosis and treatment of serious diseases, particularly cancers. Its pipeline includes products such as SARTATE, a next-generation, highly targeted theranostic radiopharmaceutical designed for imaging and treating cancers that express somatostatin receptor 2, including neuroendocrine tumours.
Average Trading Volume: 2,607,127
Technical Sentiment Signal: Sell
Current Market Cap: A$1.24B
For an in-depth examination of CU6 stock, go to TipRanks’ Overview page.