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Kyverna Therapeutics Completes BLA Submission For Miv-Cel In SPS Completed With Request For Priority Review; Says KYSA-6 Phase 3 gMG Trial Enrollment On-Track For Completion In Mid-2027

Benzinga·11/12/2026 13:04:05

BLA submission for miv-cel in SPS completed with request for priority review 

Commercial readiness advancing for potential U.S. launch of miv-cel, which would become the first approved therapy for SPS and first approved CAR-T therapy in autoimmune disease

KYSA-6 Phase 3 gMG trial enrollment on-track for completion in mid-2027

Miv-cel’s clinical profile continues to set the benchmark for autoimmune CAR T, demonstrating durable clinical benefit and a consistent, well-tolerated safety profile across multiple neurologic autoimmune indications