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Investing.com -- Artiva Biotherapeutics, Inc. (NASDAQ:ARTV) stock soared 100% in after-hours trading on Thursday after the company announced it received FDA Fast Track Designation for its AlloNK therapy in refractory rheumatoid arthritis (RA) and selected this condition as its lead indication.
The designation makes AlloNK the first drug candidate in the deep B-cell depleting therapeutic category to receive Fast Track status for refractory RA. The company is developing AlloNK (also known as AB-101) in combination with rituximab to target patients who no longer respond to conventional RA treatments.
According to Artiva, more than 20 patients have been treated with AlloNK plus monoclonal antibody therapy across company-sponsored and investigator-initiated trials in various autoimmune diseases. The company plans to release translational data in mid-November that it expects will demonstrate consistent, deep B-cell depletion supporting the therapy’s mechanism of action.
"We are prioritizing refractory RA as our lead autoimmune indication for AlloNK given the size of this underserved population. Despite the many approved therapies in RA, there are over 100,000 patients in the United States who remain treatment refractory and could potentially benefit from a deep B-cell depleting therapy," said Fred Aslan, M.D., Chief Executive Officer of Artiva.
The company highlighted AlloNK’s potential advantages over other emerging deep B-cell depleting therapies like CAR-T and T-cell engagers, noting its infusion-ready, off-the-shelf format could make it more accessible for community rheumatology clinics where most RA patients receive treatment.
Artiva expects to share clinical response data from more than 15 refractory RA patients in the first half of 2026 and plans FDA interactions during the same period that could enable AlloNK to become the first deep B-cell depleting therapy to advance to a pivotal trial in RA.
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