Aktis Oncology Gets FDA Clearance for Phase 1 Billion Trial of Tumor Treatment

By Elias Schisgall

Aktis Oncology received clearance from the Food and Drug Administration to move ahead with a phase 1b clinical trial for AKY-2519.

The company said Monday the FDA cleared Investigational New Drug applications for AKY-2519, a miniprotein radioconjugate that targets a gene expressed in several types of tumors.

"We are excited to accelerate the AKY-2519 program to patients in need of improved treatment options, and now expect to commence a Phase 1b trial of AKY-2519 in mid-2026," Chief Executive Officer Matthew Roden said.

The company's lead miniprotein radioconjugate, AKY-1189, has received Fast Track designation from the FDA and is currently enrolling patients in a phase 1b trial.

Aktis also on Monday reported a 2025 loss of $63.7 million, compared with a loss of $44 million in 2024. The widened loss was driven by an increase of research and development expenses to $67.5 million in 2025, compared with $41 million in 2024.

Collaboration revenue rose to $6.5 million for the year, up from $1.5 million in 2024. The increase was due to revenue recognized by the company's collaboration with Eli Lilly.

The company ended the year with $226.8 million in cash, cash equivalents, and marketable securities, prior to netting an additional $335.3 million from a January initial public offering.

Aktis expects its cash position will fund operations into 2029.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

March 30, 2026 17:00 ET (21:00 GMT)