Kyverna Therapeutics presents completed miv-cel BLA submission for stiff person syndrome
KYTX•Kyverna Therapeutics completed its miv-cel biologics license application for stiff person syndrome in the fourth quarter of 2026, seeking priority review, and targets a potential U.S. launch in 2027.
1. BLA and launch plans
Kyverna Therapeutics completed its miv-cel biologics license application for stiff person syndrome in the fourth quarter of 2026 and is seeking priority review. The company targets a potential U.S. launch in 2027, with pricing expected to be at a significant premium to oncology CAR T therapies’ $500,000-$600,000.
2. Trial and cash figures
One-year trial data showed a 49% median reduction in timed walking duration, and 92% of patients remained off chronic immunotherapies for stiff person syndrome. Kyverna reported $170.6 million in cash and securities at September 30, 2026, with operating runway, including loan availability, extending into 2028. Phase 3 enrollment in generalized myasthenia gravis is expected to finish in mid-2027.
