Kyverna Therapeutics reported full registrational data for miv-cel in stiff person syndrome (SPS) and said it plans to submit the therapy to the FDA by mid-year. If approved, the company expects the treatment to become the first therapy for SPS and the first personalized CAR-T for an autoimmune disease to reach the market. The company previously reported improvements in mobility and disability, and the new disclosure expands the evidence base for regulatory review. Kyverna’s CAR-T approach uses engineered T cells designed to deplete B cells, aiming to “reset” the immune system in autoimmune disease. This is a key moment for autoimmune oncology immunotherapy, with developers watching FDA precedent for CAR-T outside traditional blood cancer indications.