Kyverna Therapeutics advanced its stiff-person syndrome (SPS) CAR T effort with full registrational trial results for mivocabtagene autoleucel (miv-cel, KYV-101). The company published a comprehensive dataset from KYSA-8, supporting rapid clinical endpoints at 16 weeks and extending to a full-view assessment of function and treatment discontinuation outcomes. Kyverna reported that a single dose drove statistically significant, clinically meaningful improvements across primary and secondary endpoints at 16 weeks. The update also described an outcome profile in which most patients regained function and all discontinued chronic immunotherapies, alongside tolerability signals appropriate for a potential first-in-class autoimmune CAR T. The company is preparing regulatory steps, including a planned BLA submission for the FDA in the first half of the year. That timeline is material because CAR T approvals for autoimmune indications would represent a distinct expansion from existing blood-cancer-only labels. The dataset tightens the case for a registrational-grade evidentiary package and increases scrutiny on comparators, manufacturing reliability, and safety monitoring expectations for a one-time therapy platform.