Artiva Biotherapeutics, Inc. (ARTV) on Friday announced positive initial data from ongoing studies evaluating its cell therapy candidate AlloNK in combination with rituximab for patients with autoimmune diseases. The company's shares were up more than 10% in pre-market trading.
Initial data showed a 71% ACR50 response rate in refractory Rheumatoid arthritis patients with at least six months of follow-up in the Phase 2a basket trial, with no patients relapsing or requiring new immunomodulatory agents.
The AlloNK treatment was well tolerated supporting outpatient administration in community rheumatology settings. No serious side effects or treatment discontinuations were reported in autoimmune patients treated with AlloNK.
Artiva also said it aligned with the U.S. Food and Drug Administration on a single registrational trial design for AlloNK in refractory rheumatoid arthritis.
The company expects to begin the registrational trial in the second half of 2026, report primary efficacy data in the second half of 2028, and potentially submit a biologics license application in 2029.
Artiva stock closed at $12.52 on Thursday, up 1.05%.
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