Kyverna Therapeutics reported updated registrational Phase II results for its CAR T candidate mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome, strengthening the case for a regulatory submission in autoimmune disease. The company shared primary analysis from the KYSA-8 trial, including statistically significant improvements across primary and secondary endpoints at 16 weeks. Kyverna also described what it expects to be a near-term FDA pathway, with plans to submit a BLA during the first half of the year. If accepted and approved, it would represent a shift in CAR T beyond hematologic malignancies into a targeted, autoimmune indication. The update adds to the competitive landscape for autoimmune cell therapies by turning durability and functional recovery into regulatory-ready evidence.