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Aktis Oncology Announces FDA Clearance of Investigational New Drug Applications for AKY-2519 and Provides Business Updates and Full Year 2025 Financial Results
Aktis Oncology announced that the FDA cleared Investigational New Drug (IND) applications for AKY-2519, a miniprotein radioconjugate targeting B7-H3, enabling a Phase 1b clinical trial to begin in mid-2026. The company also provided business updates, including the Fast Track designation for its lead candidate AKY-1189, and reported financial results for 2025, showing increased R&D expenses and a net loss of $63.7 million. With a pro forma cash position of $562.1 million after its January 2026 IPO, Aktis anticipates funding operations into 2029.