Aktis Oncology receives U.S. FDA Fast Track Designation for AKY-1189, a nectin-4 miniprotein radioconjugate

CAR-T Digest - August 2020

24 February 2026: Aktis Oncology receives U.S. FDA Fast Track Designation for AKY-1189, a nectin-4 miniprotein radioconjugate

Aktis Oncology announced that the U.S. 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
The designation comes as patients with advanced urothelial cancer who progress after existing systemic therapies face limited treatment options, underscoring the need for innovative targeted approaches such as alpha radiotherapy
The Fast Track designation is intended to facilitate development and expedite regulatory review for therapies targeting serious conditions with unmet medical needs, potentially enabling more frequent FDA interactions and eligibility for rolling submission of a future Biologics License Application
AKY-1189 is a nectin-4–targeted miniprotein radioconjugate designed to deliver the alpha-emitting isotope actinium-225 directly to tumors, leveraging Aktis’ proprietary platform to address cancers in which nectin-4 is highly expressed, including the majority of urothelial cancer cases
Aktis is currently enrolling patients in a multi-site Phase 1b clinical trial in the United States evaluating AKY-1189 across several Nectin-4–expressing tumor types, with preliminary results from the first part of the study expected in early 2027