Kyverna Therapeutics disclosed positive primary analysis results from its registrational phase II KYSA-8 trial of mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome (SPS). The company said the single-dose CAR T therapy delivered statistically significant improvements across primary and secondary endpoints at 16 weeks, with many patients regaining function. Kyverna also reported safety and tolerability consistent with expectations and stated that it plans to submit a BLA to the FDA in the first half of the year, seeking what would be the first CAR T therapy for an autoimmune disease. Separate reporting noted that investors have focused on durability signals and the potential for a first approval across a new “autoimmune CAR-T” category. If the BLA filing proceeds on schedule, the FDA review could set a precedent for benefit-risk expectations for B-cell depleting cell therapies in non-malignant indications.