Aktis Oncology Receives FDA Fast Track Designation For AKY-1189 In Metastatic Urothelial Cancer

Aktis Oncology, Inc. announced that the U.S. Food and Drug Administration has granted Fast Track designation to AKY-1189 for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have progressed following prior systemic therapies. Aktis is a clinical-stage oncology company developing targeted radiopharmaceuticals designed to expand treatment access to broader patient populations.

AKY-1189 was developed using Aktis’ proprietary miniprotein radioconjugate platform and is engineered to deliver actinium-225 (225Ac), a potent alpha-emitting radioisotope, directly to tumors expressing Nectin-4. Approximately 80–90% of urothelial cancer patients demonstrate Nectin-4 expression, making it a compelling therapeutic target in this setting.

“Patients with locally advanced or metastatic urothelial cancer who progress on systemic therapies, such as PADCEV, have limited treatment options,” said Akos Czibere, MD, PhD, Chief Medical Officer of Aktis Oncology. “The granting of Fast Track designation affords us a unique opportunity to work closely with the FDA to potentially expedite the development and review process of AKY-1189 with the goal of addressing this unmet medical need by bringing a new therapeutic option to patients with locally advanced or metastatic urothelial cancer.”

Fast Track designation is intended to facilitate the development and accelerate regulatory review of therapies that address serious conditions and unmet medical needs. Programs granted this status may benefit from more frequent interactions with the FDA and eligibility for rolling submission of a Biologics License Application.

Aktis is currently conducting a multi-site Phase 1b clinical trial (NCT07020117) across the United States evaluating AKY-1189 in patients with locally advanced or metastatic urothelial cancer, as well as breast, non-small cell lung, colorectal, cervical, and head and neck cancers. The company anticipates presenting preliminary results from Part 1 of the study in the first quarter of 2027.