Kyverna Therapeutics reported positive one-year data supporting an FDA submission for miv-cel, its autoimmune CAR-T therapy candidate for stiff person syndrome. The company emphasized durable autoimmune benefit while pointing to an unblemished safety profile in its longer-term follow-up. The update lands as peers in autoimmune CAR-T confront safety setbacks, raising the bar for manufacturers to demonstrate not only efficacy durability but also manageable toxicity over longer windows. Kyverna’s reported long-term readout is designed to reinforce confidence in risk-benefit characterization for regulatory review. For the autoimmune CAR-T space, the result highlights the continuing importance of extended follow-up and careful patient selection in determining whether the modality can broaden beyond narrow indications.