Kyverna Therapeutics Announces Publication of Registrational Miv-cel Data in Patients with Stiff Person Syndrome in JAMA Neurology

(NASDAQ:KYTX) Kyverna Therapeutics, Inc. announced the publication of the primary analysis of KYSA-8, its registrational trial of miv-cel (mivocabtagene autoleucel, KYV-101) in patients with stiff person syndrome (SPS), in the Journal of the American Medical Association (JAMA) Neurology. The KYSA-8 data were also presented at the American Academy of Neurology (AAN) Annual Meeting in April 2026 and one-year durability data were shared at MS Toronto, the joint ACTRIMS-ECTRIMS meeting. Marinos C. Dalakas, MD, PhD, Professor of Neurology at Thomas Jefferson University, served as senior author and lead study investigator. In the KYSA-8 trial, a single dose of miv-cel delivered statistically significant improvements across all primary and secondary endpoints at 16 weeks, with all patients discontinuing chronic immunotherapies. Of the 12 patients who required walking aid assistance at baseline, 67% no longer needed walking assistance at 16 weeks. The safety profile of miv-cel was consistent and well-tolerated, with no high-grade CRS or ICANS, and no cases of IEC-HS. The KYSA-8 trial was a single-arm registrational Phase 2 trial enrolling 26 adult patients with SPS who had an inadequate response to at least one immunotherapy treatment, each receiving a single dose of miv-cel. The primary endpoints were change from baseline in the Timed 25-Foot Walk (T25FW) at 16 weeks and the incidence and severity of adverse events. Secondary endpoints included the Modified Rankin Scale (mRS), Distribution-of-stiffness Index (DSI), Heightened Sensitivity Scale (HSS), and Hauser Ambulation Index (HAI). Miv-cel is a fully human, autologous, CD19-targeting CAR T-cell therapy with CD28 co-stimulation, designed for potency and tolerability, and is under investigation for B-cell driven autoimmune diseases. To date, more than 100 patients have been treated with miv-cel across a range of autoimmune diseases. SPS is a rare, progressive neurologic autoimmune disease that causes up to 80% of patients to lose mobility, requiring walking aid assistance or wheelchair use. An estimated 6,000 patients are diagnosed with SPS in the United States. There are currently no FDA-approved treatments for SPS. Kyverna’s lead candidate, miv-cel, has received three FDA Regenerative Medicine Advanced Therapy (RMAT) designations in SPS, generalized myasthenia gravis (gMG), and non-active secondary progressive multiple sclerosis (naSPMS). Kyverna is also conducting an ongoing registrational trial for gMG.

Kyverna Therapeutics Appoints Ritesh Srivastava as Chief Legal and Compliance Officer, Adding Leadership Strength to Support Commercial-Stage Transition

(NASDAQ:KYTX) Kyverna Therapeutics, Inc. announced the appointment of Ritesh Srivastava as Chief Legal and Compliance Officer, effective June 22, 2026. In connection with this appointment, Kyverna will grant Mr. Srivastava an option to purchase 260,000 shares of its common stock, with the exercise price set at the closing price of Kyverna's common stock on the date of grant. The option will vest over four years, with 25% vesting on the one-year anniversary and 1/48th vesting monthly thereafter, subject to continued service. Kyverna has initiated its rolling BLA submission for stiff person syndrome (SPS) with the FDA and recently completed a registrational trial in SPS, with an ongoing registrational trial for generalized myasthenia gravis. The company is advancing miv-cel (mivocabtagene autoleucel, KYV-101), a fully human, autologous, CD19-targeting CAR T-cell therapy, for B-cell-driven autoimmune diseases. Kyverna is also conducting KYSA trials and investigator-initiated trials in multiple sclerosis and rheumatoid arthritis. The company projects potential first approval of miv-cel in stiff person syndrome and aims to deliver durable drug-free, disease-free remission in autoimmune diseases.