Kyverna Therapeutics Announces One-year Topline Data From KYSA-8, Its Trial Of Miv-Cel In Patients With Stiff Person Syndrome, And Topline Longer-Term Follow-up Data From Phase 2 Of KYSA-6, Its Trial In Patients With Generalized Myasthenia Gravis; Topline Durability Data Reinforce Potential For Single-dose Miv-Cel To Free Patients From Lifelong Disease Burden And Chronic Immunotherapies, Further Highlighting Miv-Cel’s Differentiated Construct

Kyverna Therapeutics reported one-year topline data from its KYSA-8 trial of Miv-Cel for Stiff Person Syndrome (SPS), indicating sustained clinical benefits and potential to be the first approved therapy for SPS and CAR T-cell therapy for autoimmune diseases. The company is on track for a rolling Biologics License Application (BLA) submission completion by Q4 2026, with Phase 3 enrollment expected to finish by mid-2027. Additionally, longer-term follow-up data from the Phase 2 trial in generalized Myasthenia Gravis (gMG) showed durable effects for up to 1.5 years, with a well-tolerated safety profile reported.