Kyverna Therapeutics released the full registrational dataset for mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome from its KYSA-8 trial. The company highlighted rapid, clinically meaningful improvements across primary and secondary endpoints at 16 weeks and reiterated durable response signals from the complete dataset. The company’s next step is regulatory: Kyverna plans to submit a BLA to the FDA in the first half of the year, aiming to establish what it describes as the first CAR T therapy for an autoimmune disease. If approved, miv-cel would represent a major expansion of CAR T beyond hematologic malignancies and could reframe the competitive set for cell-based immune “reset” strategies in autoimmunity.