AKTS News & Events

Aktis Oncology announced the FDA cleared the investigational new drug applications for the company to proceed to a Phase 1b clinical trial with AKY-25191. AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in several solid tumor types including prostate and lung cancers, and is the second clinical stage miniprotein radioconjugate discovered using Aktis' proprietary platform. The company's lead miniprotein radioconjugate, AKY-1189, targeting Nectin-4, is currently enrolling patients in a Phase 1b clinical study. Aktis' miniprotein radioconjugates are designed to selectively deliver actinium-225, a highly potent alpha-emitting radioisotope, to target-expressing tumors. The company also provided business updates and reported financial results for the year ended December 31, 2025.

Aktis Oncology announced that the U.S. Food and Drug Administration, 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, a highly potent alpha-emitting radioisotope, to Nectin-4 expressing tumors. Approximately 80 - 90% of urothelial cancer patients show positive expression of Nectin-4.