Artiva Biotherapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational therapy AlloNK® (AB-101) for the treatment of refractory rheumatoid arthritis $(RA)$, in combination with rituximab. This marks the first time a drug candidate in the deep B-cell depleting therapeutic category has received this designation for refractory RA. The company is prioritizing refractory RA as the lead indication for AlloNK's development and plans to engage with the FDA in the first half of 2026 to align on pivotal trial design.
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