CU6.ASX: Positive guidance from the US FDA on Cu-64 SARTATE Phase III

Positive guidance from the US FDA on Cu-64 SARTATE Phase III

Stock	Clarity Pharmaceuticals Ltd (CU6.ASX)
Release Time	22 Dec 2025, 9:19 a.m.
Price Sensitive	Yes

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Clarity Pharmaceuticals to commence pivotal Phase III trial of Cu-64 SARTATE in neuroendocrine tumours

Key Points

Positive guidance from US FDA on Phase III trial design for Cu-64 SARTATE in neuroendocrine tumours
Trial aims to demonstrate enhanced diagnostic performance of Cu-64 SARTATE over current standard-of-care
Follows compelling preclinical and clinical data, including Phase II DISCO trial findings

Full Summary

Clarity Pharmaceuticals announced it will commence a pivotal Phase III registrational trial of its 64Cu-SARTATE diagnostic agent in patients with neuroendocrine tumours (NETs). This follows a successful End of Phase meeting with the United States Food and Drug Administration (FDA), in which all key components of the proposed trial design were agreed upon. The trial will be a multi-centre, single arm, non-randomised, open-label Phase III diagnostic clinical trial of 64Cu-SARTATE Positron Emission Tomography (PET) in approximately 70 participants. The aim is to investigate the ability of 64Cu-SARTATE PET/computed tomography (CT) to detect NETs, building on compelling preclinical and clinical trial data generated to date, including the first-in-human CL01 trial and the Phase II DISCO trial. In the DISCO trial, 64Cu-SARTATE was found to be safe and well tolerated with lesion detection substantially higher than the current standard-of-care, 68Ga-DOTATATE. 64Cu-SARTATE also showed enhanced lesion detection in the liver, the most common metastatic site for patients with gastroenteropancreatic NETs. Clarity's Executive Chairperson commented that the enhanced diagnostic capabilities of 64Cu-SARTATE offer significant potential to transform and advance both the detection and management of patients with NETs, paving the way for improved patient outcomes and more effective treatment pathways.

Guidance

Clarity Pharmaceuticals did not provide any high-importance, price-sensitive forward-looking financial metrics or other company-specific metrics in the announcement.

Outlook

Clarity Pharmaceuticals stated that the final study results from the pivotal Phase III trial are intended to support an application to the US FDA for approval of 64Cu-SARTATE as a new diagnostic imaging agent in neuroendocrine tumours. Recruitment into the trial is expected to commence in 2026.