Aktis Oncology, Inc. (NASDAQ: AKTS) announced on March 30, 2026, that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) applications for AKY-2519, a miniprotein radioconjugate targeting B7-H3, which is expressed in several solid tumor types, including prostate and lung cancers. This marks a significant milestone for the company as it prepares to initiate a Phase 1b clinical trial for AKY-2519 in mid-2026. The company also provided a business update and reported its financial results for the year ended December 31, 2025.

In the press release, Dr. Matthew Roden, President and CEO of Aktis Oncology, emphasized the company's commitment to improving outcomes for cancer patients through innovative therapies. The clearance of the IND applications for AKY-2519 is expected to accelerate the program, providing new treatment options for patients in need. The company’s lead miniprotein radioconjugate, AKY-1189, is currently in a Phase 1b clinical trial and has received FDA Fast Track designation.

For the fiscal year 2025, Aktis reported a cash position of $226.8 million as of December 31, 2025, a decrease from $297.2 million in 2024. However, following its recent IPO, the company’s pro forma cash position is approximately $562.1 million, which is expected to fund operations into 2029. Collaboration revenue increased significantly to $6.5 million in 2025, attributed to a partnership with Eli Lilly and Company, while research and development expenses rose to $67.5 million, reflecting the company’s investment in advancing its clinical programs.

The anticipated milestones for the next 12 months include preliminary data from the ongoing Phase 1b trial of AKY-1189 and results from the clinical imaging and dosimetry assessment of AKY-2519. The company is also tracking two early pipeline programs towards development candidate nomination and IND-enabling activities in early 2027. Aktis is set to operationalize its in-house Good Manufacturing Practices (GMP) facility in the second half of 2026, enhancing its manufacturing capabilities to meet clinical supply demands.



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