Nkarta, Inc. (NASDAQ: NKTX) announced on April 15 2026 that it has reached an agreement with the U.S. Food and Drug Administration to allow outpatient administration of its investigational CAR‑NK cell therapy NKX019 in the Ntrust‑1 and Ntrust‑2 autoimmune disease trials. The FDA‑approved protocol changes reduce the required monitoring period from 24 hours to 2 hours, eliminate overnight inpatient stays, and grant the company the option to re‑dose participants in both studies.
The change is expected to accelerate enrollment, shorten trial timelines, and broaden the clinical reach of NKX019. By enabling treatment at community rheumatology centers, the company can expand access to patients with rheumatoid arthritis and other B‑cell mediated autoimmune conditions, potentially increasing the size and diversity of the trial population.
Nkarta reported a net loss of $104.1 million for the full year 2025, driven largely by $90.4 million in research and development expenses. As of December 31, 2025, the company held $295.1 million in cash, cash equivalents, and investments, a balance that is projected to fund operations through 2029. Levered free cash flow over the last twelve months was negative $89.91 million, reflecting the company’s continued investment in clinical development.
CEO Paul J. Hastings said, 'Reaching agreement with the FDA on outpatient dosing – reducing the need for patient monitoring from 24 hours to 2 hours – will reduce patient burden and expand access. It will also allow us to partner with community rheumatology centers, better positioning us to execute efficiently across our clinical program while expanding access to next‑generation innovation to people from all walks of life, putting patients first.' He added, 'Our agreement with the FDA expands who we can treat – and how – in clinical trials. When the amended protocol completes IRB review and is finalized, we can begin enrolling patients with rheumatoid arthritis in Ntrust‑2. We're also gaining the flexibility to re‑dose…'
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