Kyverna Therapeutics said its patient‑specific CAR‑T therapy produced statistically significant and clinically meaningful benefits in a registrational trial for stiff person syndrome (SPS), improving mobility and stiffness. The company plans to file an application with the U.S. FDA in the first half of 2026. Kyverna’s CD19‑targeted CAR‑T showed robust primary and secondary endpoint performance in the pivotal study, prompting the company to characterize the readout as 'truly remarkable' and on track for its planned submission. SPS is a rare autoimmune disorder with no approved therapies, and Kyverna intends to position its product as the first CAR‑T approved for an autoimmune indication. If cleared, the therapy would mark a major regulatory milestone for cell therapy in autoimmune disease and could open a pathway for CAR‑T approaches beyond oncology.