Kyverna Therapeutics began a rolling submission to the FDA for its autoimmune CAR-T program miv-cel after additional natural history analysis requested by the agency. The company positioned miv-cel as intended to be the first autoimmune CAR-T to reach the market. The rolling approach suggests Kyverna is working to align its evidence package with FDA expectations while keeping the timeline for regulatory review on track. Natural history data are often critical for comparator decisions and endpoint interpretation in autoimmune settings. For the sector, the update reflects continued regulatory focus on real-world disease trajectories and evidence completeness in first-in-class cellular therapies targeting autoimmune indications.