Kyverna reported a registrational trial readout showing its personalized CD19 CAR‑T improved mobility and reduced stiffness in stiff person syndrome (SPS), a rare autoimmune disorder. The Phase II/registrational data met the study’s primary endpoint and key secondary endpoints, prompting Kyverna to plan a U.S. marketing application in the first half of 2026. The results mark a potential milestone: the first FDA filing seeking approval of a CAR‑T therapy in an autoimmune indication rather than oncology. Kyverna framed the outcome as clinically meaningful for a disease with no approved therapies and emphasized safety and durability signals that supported a regulatory submission pathway. Regulators and payers will scrutinize manufacturing consistency, long‑term safety, and real‑world feasibility for a personalized cell therapy in a non‑oncology setting. If approved, Kyverna’s program could open a new regulatory route for antigen‑targeting cell therapies in immune‑mediated diseases.