Business
Kyverna Therapeutics Announces Initiation of Rolling SPS BLA Submission and Reports First Quarter 2026 Financial Results
Positive pre-BLA meeting with FDA alignment reached on KYSA-8 single-arm trial in stiff person syndrome (SPS); rolling BLA submission initiated Miv-cel pivotal trial primary analysis results in SPS demonstrated robust, durable effect in indication with no approved therapies; launch preparations continue with appointment of Nadia Dac as Chief Commercial Officer Enrollment advances in Phase 3 trial in generalized myasthenia gravis (gMG), further derisked by Phase 2 longer-term follow-up data demon
About this update from Kyverna Therapeutics, Inc.
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