Kyverna Therapeutics reported positive pivotal data for its patient‑specific CD19 CAR‑T therapy in stiff person syndrome (SPS), showing statistically significant benefit on the trial’s primary and all secondary endpoints. The company said the results clear a path to a U.S. regulatory submission in the first half of 2026, positioning Kyverna to seek the first CAR‑T approval for an autoimmune disease. SPS is a rare, debilitating disorder with no approved therapies; the outcome highlights the expanding application of cell therapies beyond oncology into autoimmunity. Kyverna emphasized the trial’s clinical significance and plans to use the data to engage regulators about a potential approval route.