Artiva Biotherapeutics Inc (NASDAQ:ARTV) saw its stock rise about 15% in premarket trading on Monday after the U.S. Food and Drug Administration awarded Regenerative Medicine Advanced Therapy, or RMAT, designation to its investigational rheumatoid arthritis treatment.
The FDA granted RMAT status to Artiva's AlloNK when administered in combination with rituximab for the treatment of refractory rheumatoid arthritis. The designation is intended to provide access to an expedited development and review pathway, including opportunities for earlier and more frequent interactions with the FDA during development.
Clinical evidence for the program was shared at the European Alliance of Associations for Rheumatology 2026 Congress in London. Artiva presented data spanning 31 patients with rheumatologic diseases across its programs. In the company-sponsored Phase 2a basket trial focused on refractory rheumatoid arthritis, 71% of patients with six months of follow-up achieved an ACR50 response, a commonly used measure of clinical improvement.
The patients evaluated in these studies had long-standing, highly active disease and had previously received multiple targeted therapies. In the company-sponsored cohort, five of seven patients with six months of follow-up attained an ACR50 response. According to the company, as of the April 3, 2026 data cutoff, no patient had exhibited loss of response, required high-dose steroids, or initiated a new biologic or targeted synthetic disease-modifying antirheumatic drug after receiving treatment.
Safety data in the presented dataset were notable for the absence of several serious immune-related toxicities. The company reported no cases of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, AlloNK-related serious adverse events, or treatment discontinuations due to adverse events as of the data cutoff. The incidence of Grade 3 or higher infections was reported at 2%.
AlloNK is described by Artiva as an allogeneic, off-the-shelf, non-genetically modified natural killer cell therapy candidate. In addition to rheumatoid arthritis, the company also presented data at the congress related to Sjögren disease and systemic sclerosis.
Separately, Artiva has indicated that proceeds from its recent financing are expected to extend the company's cash runway into 2029.
Contextual note - The RMAT designation is intended to facilitate accelerated development and review for regenerative therapies. The clinical and safety outcomes reported by Artiva to date form the basis for that regulatory recognition.