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Aktis Oncology, Inc. reports clinical-stage oncology developments centered on targeted radiopharmaceuticals for solid tumors. The company’s miniprotein radioconjugate platform supports AKY-1189, a Nectin-4 program with potential across urothelial, breast, non-small cell lung, colorectal, cervical, and head and neck cancers, and AKY-2519, a B7-H3 program for prostate, lung, colorectal, and other solid tumors.
Recurring updates include FDA actions such as IND clearances and Fast Track designation, clinical-trial initiations, imaging and dosimetry data presentations, business and financial results, investor-conference participation, and board and committee changes. News also covers Aktis’ collaboration with Eli Lilly and Company to develop radioconjugates outside its proprietary pipeline.
Aktis Oncology (NASDAQ:AKTS) reported Q1 2026 results and pipeline progress. Cash, cash equivalents and marketable securities were $538.5 million, expected to fund operations into 2029. Collaboration revenue was $3.2 million; net loss was $18.3 million.
The company is enrolling a Phase 1b trial of AKY-1189 in Nectin-4 expressing tumors, with preliminary data expected Q1 2027. It initiated a Phase 1b trial of AKY-2519 in mCRPC, plans a basket trial in other solid tumors in H2 2026, and will present AKY-2519 imaging and dosimetry data at ASCO 2026.
Aktis Oncology (NASDAQ:AKTS) will present at the BofA Securities Health Care Conference in Las Vegas on Wednesday, May 13, 2026 at 10:00 a.m. PT.
Matthew Roden, Ph.D., President and CEO, will deliver the presentation. A live webcast and an archived replay (available ~90 days) will be accessible via the Investors section of the Aktis website.
Aktis Oncology (NASDAQ:AKTS) initiated a Phase 1b trial of AKY-2519, a B7-H3 miniprotein radioconjugate, in metastatic castration-resistant prostate cancer (mCRPC) on May 4, 2026. The program uses a two-trial strategy: an mCRPC-dedicated Phase 1b enrolling PLUVICTO®-naïve and -experienced cohorts, and a Phase 1b basket trial for lung, colorectal, and other high B7-H3 tumors planned in H2 2026. The mCRPC trial will test three dose levels per cohort with expansion at selected doses; preliminary mCRPC data are expected in 2027.
Two River and Vida Ventures acknowledged UCB's acquisition of Candid Therapeutics for up to $2.2 billion, including $2.0 billion upfront. Two River and Third Rock helped found Candid via the merger of TRC 2004 and Vignette Bio; Vida was an early investor. The announcement highlights Bellco Health's company-creation and investment track record, and notes Vida's 2025 M&A activity and two oversubscribed 2026 IPOs including Aktis Oncology (AKTS) and Avalyn Pharma (AVLN).
Aktis Oncology (NASDAQ:AKTS) will present first clinical imaging and dosimetry data for AKY-2519, a B7-H3–targeted miniprotein radioconjugate, in two poster sessions at the ASCO Annual Meeting (May 29–June 2, 2026).
The company received FDA clearance of INDs in March 2026 and plans a Phase 1b trial to start mid-2026. AKY-2519 delivers actinium-225 to B7-H3–expressing tumors; imaging studies were conducted in South Africa and Germany. Aktis' lead candidate AKY-1189 remains in Phase 1b enrollment.
Aktis Oncology (NASDAQ:AKTS) appointed Glenn Gormley, MD, PhD to its Board and named him co-chair of a new Science and Technology Committee, effective April 16, 2026. Dr. Gormley brings 30+ years of R&D leadership, including ADC platform development at Daiichi Sankyo, and will support upcoming clinical and corporate milestones.
Board members Helen Kim and Oleg Nodelman plan to step down, effective May 20, 2026.
Aktis Oncology (NASDAQ:AKTS) announced FDA clearance of IND applications for AKY-2519 (imaging [64Cu] and therapeutic [225Ac]) and plans a Phase 1b trial starting mid-2026. The company reported full-year 2025 results, pro forma cash of $562.1M after a January 2026 IPO, collaboration revenue of $6.5M, and continued investment in AKY-1189 and early programs.
Key near-term milestones include AKY-1189 preliminary data in Q1 2027, AKY-2519 imaging results mid-2026, GMP facility H2 2026 readiness, and two early programs targeting IND-enabling work in Q1 2027.
Aktis Oncology (NASDAQ:AKTS) announced that President and CEO Matthew Roden, Ph.D., will present at two investor conferences in March 2026: TD Cowen on March 3 and Leerink Partners on March 9.
Live webcasts will be available via the company's Investors site and archived replays will remain for about 90 days after each conference.
Aktis Oncology (NASDAQ:AKTS) said the U.S. FDA granted Fast Track designation to AKY-1189 for adult patients with locally advanced or metastatic urothelial cancer who progressed after prior systemic therapies. AKY-1189 is an actinium-225 miniprotein radioconjugate targeting Nectin-4, which is expressed in approximately 80–90% of urothelial cancers.
Aktis is enrolling a multi-site Phase 1b trial (NCT07020117) across multiple Nectin-4 tumor types and expects to present preliminary Part 1 results in Q1 2027. Fast Track may enable more frequent FDA interactions and rolling BLA submission eligibility.
Aktis Oncology (NASDAQ: AKTS) closed an upsized initial public offering of 17,650,000 shares at $18.00 per share on January 12, 2026, and the underwriters fully exercised an option to purchase an additional 2,647,500 shares at the same price, with that sale expected to close on January 14, 2026, subject to customary conditions.
The aggregate gross proceeds including the overallotment are expected to be approximately $365.4 million before underwriting discounts, commissions and offering expenses. Aktis began trading on the Nasdaq Global Select Market on January 9, 2026 under the ticker AKTS.