Kyverna Therapeutics began a rolling submission to the FDA for miv-cel, aiming to position the candidate as the first autoimmune CAR-T therapy to reach the market. The company said it is performing additional natural history analysis in response to FDA requests while maintaining its submission timeline. Kyverna’s update underscores the regulatory emphasis on long-term disease course characterization in autoimmune indications, where safety and durability considerations are central to review pathways. The move keeps miv-cel on track toward a potential first-in-class approval path.