Artiva reports Q2 2026 results, RMAT for AlloNK in refractory RA, Phase 3 plan
Artiva said it will begin a Phase 3 trial of AlloNK plus rituximab in refractory rheumatoid arthritis in the second half of 2026 after FDA granted RMAT designation, with cash extending into 2029.
Artiva Biotherapeutics reported second quarter 2026 financial results and business updates on August 6, 2026. The company said the FDA granted RMAT designation to AlloNK plus rituximab for refractory rheumatoid arthritis, a designation that supports Artiva's planned registrational strategy and provides access to expedited development and review mechanisms, including increased opportunities for FDA interaction.1
Artiva said it plans to start a Phase 3 registrational trial in the second half of 2026 comparing AlloNK plus rituximab against rituximab alone. The trial will enroll approximately 150 RA patients who have had an inadequate response to two or more b/tsDMARDs of distinct classes, using ACR50 response at six months as the primary efficacy endpoint.1
The company also presented data at EULAR 2026 from its Phase 2a basket trial. As of an April 3, 2026 cutoff, five of seven patients (71%) with six months of follow-up achieved an ACR50 response1 in refractory RA, and no patient had lost response, required high-dose steroids or started a new b/tsDMARD following treatment with AlloNK plus rituximab.1 In Sjögren disease and systemic sclerosis cohorts, SjD patients (n=11) showed improvements across clinical, patient-reported and functional measures, including normalized salivary flow among those with six months of follow-up, while SSc patients (n=5) showed an average 9.5-point drop in modified Rodnan skin score among those with six months of follow-up, with all achieving rCRISS25.1
On safety, among 55 evaluable autoimmune patients treated with AlloNK plus rituximab, the company reported no cases of cytokine release syndrome, ICANS, AlloNK-related serious adverse events, or discontinuations due to adverse events, with a 2% rate of Grade 3 or higher infections and no hospitalizations for infection in the first 28 days.1
In May 2026, Artiva raised roughly $300 million through an underwritten offering of common stock and pre-funded warrants, before underwriting discounts, commissions and offering expenses.1 As of June 30, 2026, the company reported cash, cash equivalents and investments of $349.4 million, which is expected to fund operations into 2029.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.