Aktis Oncology receives FDA clearance for AKY-2519 drug trials

Aktis Oncology Inc. (NASDAQ: AKTS) announced the U.S. Food and Drug Administration cleared investigational new drug applications for AKY-2519, allowing the company to proceed with a Phase 1b clinical trial expected to begin in mid-2026.

AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in solid tumor types including prostate and lung cancers. The drug is designed to deliver actinium-225, an alpha-emitting radioisotope, to target-expressing tumors.

The FDA granted Fast Track designation in February 2026 for the company's lead drug candidate AKY-1189 for treating adult patients with locally advanced or metastatic urothelial cancer who have progressed after prior systemic therapies. AKY-1189 is currently enrolling patients in a Phase 1b clinical study.

Aktis completed an initial public offering in January 2026, raising $365.4 million in gross proceeds. The company reported a pro forma adjusted cash position of $562.1 million as of year-end 2025, which it expects will fund operations into 2029.

For the year ended December 31, 2025, Aktis reported collaboration revenue of $6.5 million, compared to $1.5 million in 2024. Research and development expenses increased to $67.5 million from $41.0 million in the prior year. Net loss widened to $63.7 million from $44.0 million in 2024.

The company plans to make its in-house Good Manufacturing Practices facility operational in the second half of 2026. Preliminary data from the AKY-1189 Phase 1b clinical trial are expected in the first quarter of 2027.

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