Kyverna Therapeutics started a rolling submission to the FDA for its miv-cel autoimmune CAR-T candidate, while conducting additional natural history analysis after the agency requested more data. The company said the program remains positioned to be the first autoimmune CAR-T to reach the market. The FDA’s request reinforces how regulators are scrutinizing clinical evidence in autoimmune CAR-T use cases, where durability, immune effects and disease course information can be harder to interpret than in oncology. For developers, the update is a reminder that natural history studies and evidentiary completeness can be decisive for CAR-T review timelines—particularly for off-oncology indications.