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Artiva Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its AlloNK product in combination with rituximab for the treatment of refractory rheumatoid arthritis.
The RMAT designation is intended to expedite the development and regulatory review of promising regenerative medicine therapies that address unmet medical needs. This marks a significant milestone for Artiva Biotherapeutics, Inc. as the company advances its therapeutic pipeline targeting difficult-to-treat autoimmune diseases.
Artiva Biotherapeutics plans a Phase 3 trial of AlloNK targeting deep B-cell depletion in refractory rheumatoid arthritis. CEO Fred Aslan is expected to discuss AlloNK Phase 3 developments at the 2026 Jefferies Healthcare Conference. The company continues to advance its clinical program for difficult-to-treat autoimmune conditions.