Kyverna Therapeutics Advances Toward First CAR-T Approval in Autoimmune Diseases with Strong SPS Trial Data
Kyverna unveiled full results from phase 2 KYSA-8 registrational trial of miv-cel in stiff person syndrome (SPS), meeting all primary, secondary, and exploratory endpoints.
Trial showed median 46% improvement in timed 25-foot walking test at 4 months, with >80% of patients achieving ≥20% improvement.
Plans to file U.S. FDA application for miv-cel in SPS in first half of 2026, potentially first CAR-T for autoimmune disease.
100% response rate confirmed in generalized myasthenia gravis (gMG) from phase 2/3 KYSA-6 trial with 7 patients.
KYV-101 CAR-T targets CD19 for B-cell depletion in autoimmune diseases like lupus nephritis and myasthenia gravis.
Company shares rose >25% following SPS data announcement on April 21, 2026.