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Aktis Oncology Reports First-in-Human Clinical Imaging and Dosimetry Data for AKY-2519 Demonstrating Robust Tumor Uptake and Limited Normal Tissue Exposures in Patients with B7-H3 Expressing Tumors

Aktis Oncology Reports First-in-Human Clinical Imaging and Dosimetry Data for AKY-2519 Demonstrating Robust Tumor Uptake and Limited Normal Tissue Exposures in Patients with B7-H3 Expressing Tumors

BOSTON, May 21, 2026 -- Aktis Oncology, Inc. (NASDAQ:AKTS) (Aktis or the Company), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, today reported first-in-human clinical imaging and dosimetry data for AKY-2519, a miniprotein radioconjugate targeting B7-H3 expressing tumors. The data from two separate assessments of AKY-2519 – a clinical imaging and dosimetry assessment in patients with mCRPC and a clinical imaging assessment in patients with various solid tumor types – demonstrated robust tumor uptake and limited normal tissue exposure. These findings, which supported the advancement of a broad clinical development program for AKY-2519, will be presented in two poster presentations at the upcoming 2026 ASCO Annual Meeting, being held May 29 – June 2, 2026, in Chicago.

0-Homepage Feature / 0-Megaphone / Aktis Oncology - 05/21/2026

Aktis Oncology Initiates Phase 1b Clinical Trial for AKY-2519, a B7-H3 Miniprotein Radioconjugate, in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

BOSTON, May 04, 2026 -- Aktis Oncology, Inc. (NASDAQ:AKTS) (Aktis or the Company), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, today announced the initiation of a Phase 1b clinical trial of AKY-25191 in patients with metastatic castration-resistant prostate cancer (mCRPC). The mCRPC-dedicated Phase 1b trial is part of Aktis’ clinical development strategy to develop AKY-2519 broadly in B7-H3 expressing tumors. Aktis plans to initiate a Phase 1b basket trial in lung, colorectal, and other high B7-H3 expressing solid tumors in the second half of 2026.

Aktis Oncology - 05/04/2026

Aktis Oncology Announces FDA Clearance of Investigational New Drug Applications for AKY-2519

BOSTON, March 30, 2026 -- Aktis Oncology, Inc. (NASDAQ:AKTS) (the “Company”), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, today 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. AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in several solid tumor types including prostate and lung cancers, and is the second clinical stage miniprotein radioconjugate discovered using Aktis’ proprietary platform. The Company’s lead miniprotein radioconjugate, AKY-1189, targeting Nectin-4, is currently enrolling patients in a Phase 1b clinical study. Aktis’ miniprotein radioconjugates are designed to selectively deliver actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to target-expressing tumors.

Uncategorized - 04/15/2026

Aktis Oncology Receives U.S. FDA Fast Track Designation for AKY-1189, a Nectin-4 Miniprotein Radioconjugate

BOSTON, Feb. 24, 2026 -- Aktis Oncology, Inc. (NASDAQ:AKTS), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies, today 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. Approximately 80 – 90% of urothelial cancer patients show positive expression of Nectin-4.

Aktis Oncology - 02/24/2026

Aktis Oncology Announces Pricing of its Upsized Initial Public Offering

BOSTON, Jan. 08, 2026 -- Aktis Oncology, Inc. (“Aktis”), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies, today announced the pricing of its upsized initial public offering of 17,650,000 shares of its common stock at a price to the public of $18.00 per share. In addition, Aktis has granted the underwriters a 30-day option to purchase up to an additional 2,647,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses payable by Aktis, are expected to be approximately $318.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. All of the shares of common stock are being offered by Aktis. Aktis’ common stock is expected to begin trading on the Nasdaq Global Select Market under the ticker symbol “AKTS” on January 9, 2026. The offering is expected to close on January 12, 2026, subject to satisfaction of customary closing conditions.

Aktis Oncology - 01/09/2026

Aktis Oncology Initiates Phase 1B Clinical Trial of its Nectin-4-Targeting Radiopharmaceutical Product Candidate, AKY-1189, Across Multiple Tumor Types

BOSTON, May 28, 2025 -- Aktis Oncology, Inc., an oncology company focused on unlocking the breakthrough potential of targeted radiopharmaceuticals for patient populations not addressed by existing platform technologies, today announced that it has initiated clinical development of AKY-1189 in its Phase 1b clinical trial for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC), triple negative breast cancer (TNBC) and potentially other Nectin-4 expressing tumors.

Aktis Oncology - 05/28/2025

Aktis Oncology Announces Presentation of the First Clinical Data Supporting Broad Development of their First in Class Nectin-4 Targeting Radiopharmaceutical AKY-1189

BOSTON, Oct. 24, 2024 -- Aktis Oncology, a clinical-stage oncology company focused on unlocking the breakthrough potential of targeted radiopharmaceuticals for large patient populations not addressed by existing platform technologies, today announced data presented on its potential first-in-class, Nectin-4 targeting mini-protein radiopharmaceutical, AKY-1189, in three abstracts, including one oral presentation, at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain, October 23-25, 2024. AKY-1189 is designed to deliver actinium-225 to Nectin-4 expressing tumors, with potential applications in locally advanced or metastatic urothelial carcinoma (mUC) and other Nectin-4 expressing cancers, such as breast, lung, colorectal and cervical.

Aktis Oncology - 10/24/2024

Aktis Oncology Announces $175 Million Oversubscribed Series B Financing to Further Advance its Proprietary Radiopharmaceutical Pipeline

BOSTON, Sept. 30, 2024 -- Aktis Oncology, a clinical-stage biotechnology company pioneering the discovery and development of novel targeted alpha radiopharmaceuticals to treat a broad range of solid tumors, today announced the successful closing of an oversubscribed and upsized $175 million Series B financing. The financing was led by RA Capital Management, and co-led by RTW Investments and Janus Henderson Investors. A select syndicate of additional new investors joined the financing, including funds and accounts advised by T. Rowe Price Associates, Inc., Avidity Partners, and an undisclosed life sciences-focused investment fund. All existing institutional investors participated, as well as existing strategic investors Bristol Myers Squibb, Eli Lilly and Company, and MRL Ventures Fund, the therapeutics-focused corporate venture fund of Merck & Co., Inc.

Aktis Oncology - 09/30/2024

Aktis Oncology enters into Strategic Collaboration with Lilly

BOSTON, Mass. – May 21, 2024 — Aktis Oncology, a biotechnology company discovering and developing novel targeted radiopharmaceuticals to treat a broad range of solid tumors, today announced a multi-target discovery collaboration agreement with Eli Lilly and Company to generate anticancer radiopharmaceuticals using Aktis Oncology’s novel miniprotein technology platform. The collaboration draws on Aktis’ proprietary radiopharmaceutical platform together with Lilly’s expertise in oncology drug development and commercialization, with the goal of developing first- in-class and differentiated therapeutics for a range of solid tumors.

Aktis Oncology - 05/21/2024

Aktis Oncology Raises $84 Million to Advance Novel Targeted Alpha Radiopharmaceuticals

CAMBRIDGE, Mass., Aug. 25, 2022 -- Aktis Oncology, a biotechnology company discovering and developing novel classes of targeted alpha radiopharmaceuticals to treat a broad range of solid tumors, today announced it has raised a Series A Extension financing of $84 million, bringing the total capital raised to date to $161 million. The extension included participation from new premier healthcare investors Cowen Healthcare Investments, MRL Ventures Fund, the therapeutics-focused corporate venture fund of Merck & Co., Inc., ArrowMark Partners, Mirae Asset Venture Investment, Timefolio Capital (formerly known as NS Investment), Pappas Capital, and other undisclosed participants. All existing investors MPM Capital, Vida Ventures, EcoR1 Capital, Octagon Capital, TCG Crossover, Bristol Myers Squibb, and Novartis participated in the financing.

Aktis Oncology / Specialized Holdings - 08/25/2022
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