This section highlights FDA-related milestones and regulatory updates for drugs developed by Aktis Oncology (AKTS).
Over the past two years, Aktis Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AKY-2519 and AKY-1189. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
AKY-2519 FDA Regulatory Events
AKY-2519 is a drug developed by Aktis Oncology for the following indication: in patients with Nectin-4 expressing tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AKY-2519
- Announced Date:
- April 21, 2026
- Indication:
- in patients with Nectin-4 expressing tumors
Announcement
Aktis Oncology, Inc. announced that clinical imaging and dosimetry data of AKY-2519 in patients with various B7-H3 expressing solid tumors will be presented in two poster presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 29 – June 2, 2026, in Chicago.
AI Summary
Aktis Oncology announced that clinical imaging and dosimetry data for AKY-2519, a miniprotein radioconjugate that targets B7-H3, will be shown in two poster presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, May 29–June 2 in Chicago. The presentations will report results from patients with various B7-H3–expressing solid tumors and offer early human data on the agent.
The data help build an initial picture of AKY-2519’s biodistribution and predicted absorbed radiation doses in tumors and normal tissues, which can guide safe and effective dosing. Aktis also said a Phase 1b clinical trial of AKY-2519 is planned to begin in mid-2026. These poster presentations are intended to inform clinicians and researchers about early imaging and dosimetry findings as the drug moves into its next clinical stage.
Read Announcement- Drug:
- AKY-2519
- Announced Date:
- March 30, 2026
- Indication:
- in patients with Nectin-4 expressing tumors
Announcement
Aktis Oncology, Inc. announced the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) applications for the Company to proceed to a Phase 1b clinical trial with AKY-25191.
AI Summary
Aktis Oncology announced the FDA cleared Investigational New Drug (IND) applications for AKY-2519, allowing the company to proceed to a Phase 1b clinical trial. AKY-2519 is a miniprotein radioconjugate designed to deliver the alpha emitter actinium-225 to tumors that express the B7-H3 protein, which is found on several solid tumor types such as prostate and lung cancer. The cleared INDs cover both an imaging form ([64Cu]Cu-AKY-2519) to track biodistribution and an alpha-therapy form ([225Ac]Ac-AKY-2519) for treatment.
The imaging and dosimetry assessments will help determine how the agent spreads and accumulates in tumors and normal tissues, guiding safe dosing for the Phase 1b study. Aktis expects to start the Phase 1b trial in mid-2026, moving AKY-2519 into formal clinical testing focused on safety, dosing, and early evidence of activity that could support later registration studies.
Read Announcement
AKY-1189 FDA Regulatory Events
AKY-1189 is a drug developed by Aktis Oncology for the following indication: Nectin-4 Miniprotein Radioconjugate.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AKY-1189
- Announced Date:
- February 24, 2026
- Indication:
- Nectin-4 Miniprotein Radioconjugate
Announcement
Aktis Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AKY-1189 for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have progressed on or after prior systemic therapies. Generated using Aktis' miniprotein radioconjugate platform, AKY-1189 is designed to deliver actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to Nectin-4 expressing tumors.
AI Summary
Aktis Oncology announced that the U.S. Food and Drug Administration has granted Fast Track designation to AKY-1189 for treating adult patients with locally advanced or metastatic urothelial cancer who have progressed on or after prior systemic therapies. An ongoing Phase 1b trial is enrolling patients with urothelial cancer and several other tumor types that express Nectin-4. Fast Track status is intended to help speed the development and review of therapies for serious conditions and unmet needs.
AKY-1189 is built on Aktis’ miniprotein radioconjugate platform and is designed to deliver actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, directly to Nectin-4 expressing tumors. By combining a targeting miniprotein with 225Ac, the therapy aims to concentrate powerful, short-range radiation in cancer cells while limiting exposure to surrounding healthy tissue. The Fast Track designation may enable more frequent FDA interaction and expedited review as clinical testing continues.
Read Announcement
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