Kyverna Therapeutics' miv-cel showed improved mobility and a favorable safety profile at one year in patients with stiff person syndrome, further derisking an upcoming FDA application, William Blair said on Thursday. The biotech plans to file for priority review this year.

Original title: “Kyverna steps closer to FDA-first CAR T for an autoimmune condition with durability data”

exteroceptive reflexes in stiff person syndrome other neurological conditions and healthy controls

Original title: “Exteroceptive Reflexes in Stiff Person Syndrome, Other Neurological Conditions and Healthy Controls.”

May 4, 2026 Kyverna Therapeutics Appoints Nadia Dac, Seasoned Commercial Leader in Neurology and Rare Disease, as Chief Commercial Officer · Apr 21, 2026 Kyverna Presents Registrational Trial Primary Analysis for Miv-cel in Stiff Person Syndrome Demonstrating Statistically Significant, Durable Clinical ... May 4, 2026 Kyverna Therapeutics Appoints Nadia Dac, Seasoned Commercial Leader in Neurology and Rare Disease, as Chief Commercial Officer · Apr 21, 2026 Kyverna Presents Registrational Trial Primary Analysis for Miv-cel in Stiff Person Syndrome Demonstrating Statistically Significant, Durable Clinical Benefit Across All Endpoints in an Oral, Late-Breaker Session at AAN Annual Meeting Updated Phase 1 COMPARE data at EULAR 2026 show miv-cel’s deep B-cell depletion, 66.6% ACR70 at Week 36, and no high-grade CRS or ICANS; Phase 2 enrolled. Data reinforce miv-cel’s differentiated clinical profile and opportunity to change the treatment paradigm across a variety of autoimmune diseases · EMERYVILLE, Calif., June 03, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company developing cell therapies for patients with autoimmune diseases, today announced the presentation of updated data from the Phase 1 portion of COMPARE, a Phase 1/2 investigator-initiated trial (IIT) evaluating miv-cel (mivocabtagene autoleucel, KYV-101) in patients with active anti-citrullinated protein antibody (ACPA)-positive, treatment-refractory rheumatoid arthritis (RA). The use of miv-cel (KYV-101) in the IH setting is not a substitute for, nor intended to replace, Kyverna’s clinical trials. The goal is not to assess the effectiveness of a potential therapy, but rather to provide an individual patient with a possible efficacious approach when all other treatment options have failed, as determined by the patient’s physician. Kyverna reported that a single miv-cel dose reduced disease activity in all six patients.

Original title: “New RA cell therapy clears disease-driving B cells in early trial”

Despite understanding the link ... many rare diseases, the underlying cause of stiff person syndrome is not well understood. This makes it very difficult to diagnose and treat it, explained Gehchan. “There is a significant need for therapies that deliver durable and substantial clinical benefit while eliminating the burden and risks of chronic, off-label treatment,” said Gehchan. At present, there is only one noteworthy therapy in clinical trials for stiff ... Despite understanding the link between GAD65 and GlyR antibodies and the condition, like with many rare diseases, the underlying cause of stiff person syndrome is not well understood. This makes it very difficult to diagnose and treat it, explained Gehchan. “There is a significant need for therapies that deliver durable and substantial clinical benefit while eliminating the burden and risks of chronic, off-label treatment,” said Gehchan. At present, there is only one noteworthy therapy in clinical trials for stiff person syndrome, and it is California-based Kyverna Therapeutics’ CAR T-cell therapy miv-cel. No medicines exist for stiff person syndrome yet, but a new CAR T-cell therapy from Kyverna Therapeutics is moving closer to approval. “Current off-label treatments fail the majority of people with stiff person syndrome, require chronic dosing, and do not stop the progression of the disease,” said Gehchan. “There is a significant need for therapies that deliver durable and substantial clinical benefit while eliminating the burden and risks of chronic, off-label treatment.” No currently available medicines treat the root cause of the syndrome, but Kyverna Therapeutics’ cell therapy has been making steady progress and is poised for regulatory approval. Extremely rare, stiff person syndrome affects around one in a million people. It was first identified by two neurologists at the Mayo Clinic in Minnesota in 1956, and was described, at the time, as a “mystery illness that stiffens victims.” Public awareness grew when the singer Celine Dion announced her diagnosis in 2022.

Original title: “Kyverna CAR-T therapy for stiff person syndrome nears approval”

sj gren s disease and stiff person syndrome a case series highlighting a rare but significant autoimmune overlap

Original title: “Sjögren's Disease and Stiff Person Syndrome: A case series highlighting a rare but significant autoimmune overlap.”