Aktis Oncology receives US FDA fast track designation for AKY-1189, a nectin-4 miniprotein radioconjugate

Aktis Oncology

24 February 2026 - Aktis Oncology today announced that the US FDA has granted fast track designation to AKY-1189 for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have progressed on or after prior systemic therapies. 

Generated using Aktis’ miniprotein radioconjugate platform, AKY-1189 is designed to deliver actinium 225 (225Ac), a highly potent alfa emitting radioisotope, to nectin-4 expressing tumours. 

Approximately 80-90% of urothelial cancer patients show positive expression of nectin-4.

Read Aktis Oncology press release 

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Fast track