Kyverna Therapeutics disclosed positive registrational Phase II results for mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome, including rapid improvements by week 16 and a high rate of patients stopping chronic immunotherapies. The company plans to submit a BLA to the FDA in the first half of this year. The readout strengthens the case for CAR T cell approaches in autoimmune disease, where safety and durable efficacy have been recurring concerns. For investors and developers, the milestone also provides another data point in a growing category that aims to replace indefinite immunosuppression with finite, potentially disease-modifying therapy. In parallel, Eledon Pharmaceuticals reported early clinical-trial outcomes for tegoprubart, a monoclonal antibody immunosuppressant designed to block CD40 ligand signaling in the islet transplant setting. In a cohort of 12 type 1 diabetes patients, Eledon said 100% achieved insulin independence with no reported graft rejection episodes, positioning the program as a more targeted alternative to broad immunosuppression.