How Kyverna rode CAR T’s autoimmune wave to the FDA’s door

News Business How Kyverna rode CAR T’s autoimmune wave to the FDA’s door July 20, 2026 | 3 min read | Annalee Armstrong Twitter LinkedIn Facebook Email Print Poised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm. When cell therapy suddenly veered from oncology into autoimmune disease a few years ago, Kyverna Therapeutics was already in the lab.As the first human data in lupus emerged from Europe, Kyverna was hard at work in parallel with the National Institutes of Health on a next generation CAR T construct called miv-cel. That preclinical research showed potency, durability and improved safety over existing cell therapies in lymphoma but also pointed to broader applications in B cell-driven autoimmune diseases. Kyverna licensed the asset from the NIH for autoimmune indications in January 2022.The prescient decision paid off. Miv-cel is now poised to become the first CAR T cell therapy approved for an autoimmune disease, according to analysts from William Blair. Cell therapy has been a tough space for smaller biotechs, which have struggled under the weight of commercialization and manufacturing challenges. Pharmas like Gilead Sciences and Bristol Myers Squibb—much larger organizations with bigger sales forces—have found more success. But Kyverna’s small nature is a feature, not a drawback, according to CEO Warner Biddle, who spoke to BioSpace on the sidelines of the BIO International Convention last month.“Sometimes being smaller and being nimble and being able to focus allows you to start to accelerate,” Biddle said. Rare diseases Kyverna’s CAR T Therapy Delivers ‘Impressive’ Mobility Benefits in Stiff Person Syndrome Kyverna plans to submit mivocabtagene autoleucel to the FDA for approval in the first half of 2026. If approved, it would be the first CAR T therapy for an autoimmune disease. December 16, 2025 · 2 min read · Tristan Manalac Read more Kyverna is working to file a biologics license application by the end of the year, requesting market approval for miv-cel to treat stiff person syndrome (SPS), a rare autoimmune disorder that causes muscle rigidity and severe spasms. There are an estimated 6,000 patients in the U.S. with the malady and there is currently no specific treatment approved for the population. The disease thus progresses to disability in about 80% of patients, Biddle said, requiring a walker or wheelchair.In Kyverna’s registrational Phase 2 clinical trial, two-thirds of patients who were using a mobility aid at the beginning of the study were able to get around without it after treatment with miv-cel. The patients were able to walk easier and faster, while also getting off background immunosuppressant agents that can come with difficult side effects. Miv-vel is taken only once and patients move on with their lives, Biddle explained. Many patients who went through Kyverna’s trial are still demonstrating strong results two years out, he added.“In a way we’re providing this tremendous clinical benefit for patients, but we’re also changing the paradigm of how autoimmune diseases are being managed, which we’re really proud to be a part of and leading,” the CEO said.Kyverna tackled the relatively small indication of SPS first to get a feel for the market. Then, the team will go after a much larger market in generalized myasthenia gravis, which has recently seen a rush of new treatment options. Companies with approved treatments for the disease include Amgen, Johnson & Johnson, AstraZeneca and argenx.“All the treatments that are managing and approved for this indication right now aren’t doing what we’re doing with miv-cel,” Biddle said. These drugs are providing modest improvement in clinical symptoms and on key measurement scales of the disease. But the Phase 2 trial for miv-cel has gone even further, bringing patients to minimal symptom expression. William Blair analysts heralded a recent readout at the American Academy of Neurology‘s annual meeting as “setting a new efficacy standard in the field.” Neuroscience AAN 2026: J&J, Kyverna, Capricor and Praxis showcase practice-changing data This year’s American Academy of Neurology meeting included a presentation that could one day set a new treatment standard for myasthenia gravis. April 23, 2026 · 4 min read · Tristan Manalac Read more Miv-cel could ultimately be a pipeline-in-a-product for Kyverna. The company is focused on neuroimmunology disease, with additional trials underway in progressive multiple sclerosis. So far, the early data have shown improvements in disability and fatigue.“When you ask the experts that have been treating these patients for many years, they’ll say we’ve never seen this before,” Biddle said.But the pipeline will begin with SPS, providing Kyverna with an introduction to being a commercial biotech and the accolade of having brought to market the first-ever cell therapy for autoimmune disease.“We know we’re onto something with this . . . paradigm-shifting way of managing these diseases,” Biddle said. “We’ve got a bold vision. We’re starting with SPS, and we want to bring this to more patients and larger indications over time.” Twitter LinkedIn Facebook Email Print Autoimmune disease Cell therapy FDA CAR-T Annalee Armstrong Annalee Armstrong is senior editor at BioSpace. You can reach her at annalee.armstrong@biospace.com. Follow her on LinkedIn.