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
Benzinga · 3d ago
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Sustained clinical benefit and reversal of disability through one year support the potential to be the first approved therapy in SPS and first approved CAR T-cell therapy for autoimmune disease; rolling BLA submission on track for completion in Q4 2026
Longer-term Phase 2 follow-up in gMG demonstrate robust and durable effects sustained for up to 1.5 years, with majority of patients maintaining MSE;
Phase 3 enrollment expected to be completed in mid-2027
Consistent, well-tolerated safety profile with no high-grade CRS or ICANS, and no cases of IEC-HS in one-year follow-up
Company to host conference call on September 24, 2026 at 8 am ET
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