Kyverna Therapeutics announced pivotal-trial results in stiff person syndrome (SPS) that met the study’s primary and all secondary endpoints, prompting plans for a U.S. filing in the first half of 2026. The company described the outcomes as ‘highly statistically significant’ and said the data support a marketing application for a CD19-directed, patient-specific CAR‑T therapy in an autoimmune indication with no approved therapies. The registrational success marks a strategic milestone: a potential first-in-class approval of CAR‑T for an autoimmune disease rather than oncology. Kyverna intends to leverage the pivotal data package to request accelerated review and to prepare manufacturing and clinical-scale logistics necessary for commercialization and broader use. CAR‑T in autoimmunity targets pathogenic B cells and could redefine treatment paradigms for refractory, rare autoimmune disorders. Patient-specific autologous CAR‑T products require robust manufacturing and reimbursement planning; regulators will focus on durability of response and safety in a non-oncology population.