Aktis Oncology (AKTS) said late Monday that the US Food and Drug Administration cleared its investigational new drug applications, allowing it to proceed to a phase 1b clinical trial of AKY-2519, expected to begin in mid-2026.

AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in multiple solid tumor types including prostate and lung cancers, the company said.

Results from the clinical imaging and dosimetry assessment of AKY-2519 in patients with various solid tumors are expected in mid-2026, the company added.

The company said its cash position will fund its operations into 2029.