Artiva Biotherapeutics secures FDA alignment for Phase 3 RA trial after strong Phase 2a results

Artiva Biotherapeutics (NASDAQ:ARTV) has reached a pivotal regulatory milestone, securing FDA alignment for a single Phase 3 registrational trial of its lead candidate, AlloNK, following positive initial data in refractory rheumatoid arthritis (RA).

The San Diego-based clinical-stage biotech reported that its Phase 2a trial of AlloNK (AB-101) achieved a 71% ACR50 response rate in refractory RA patients with at least six months of follow-up.

Furthermore, evaluable patients demonstrated complete "deep B-cell depletion," a key biomarker for the therapy’s intended mechanism of action in B-cell driven autoimmune diseases.

Following these results, the company finalized a development path with the FDA for a single Phase 3 registrational trial.

The randomized study will evaluate AlloNK plus rituximab versus rituximab alone in approximately 150 patients who have failed prior biologic or targeted therapies.

The primary endpoint will be the ACR50 response at six months.

Financially, Artiva reported holding $86.8 million in cash, cash equivalents, and investments as of March 31, 2026.

Management expects this capital to fund operations into the second quarter of 2027.

The company’s current liquidity supports the immediate transition into the registrational phase of its lead program.