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KYV-101 (miv-cel)Kyverna Therapeutics—KYSA-8 trial demonstrates positive topline data for miv-cel in stiff person syndromeKYV-101 (miv-cel)Kyverna Therapeutics—Kyverna reports one-year data for miv-cel in stiff person syndrome and myasthenia gravis

KYV-101 (miv-cel)

by Kyverna TherapeuticsUS

Autologous CAR-T targeting CD19+ B cells for autoimmune disease. Designed to treat stiff person syndrome, myasthenia gravis, and lupus nephritis.

PilotStage 3 of 5

KYSA-8 Phase 2 complete: 49% median timed-walk improvement. Rolling BLA completion targeted Q4 2026.

Updated Sep 2026Checked 10 Oct0 updates this week

Milestones

Next · BLA submission completion (planned)
  1. FDA RMAT and Orphan Drug designations granted2023Complete.
  2. KYSA-8 Phase 2 trial in stiff person syndrome enrolls first patients2023Complete.
  3. KYSA-8 Phase 2 enrollment 70% completeSep 2026Complete.
  4. KYSA-8 topline data releaseDec 2025Complete.
  5. Rolling BLA submission initiatedDec 2025Complete.
  6. BLA submission completion (planned)Target Q4 2026Current milestone.
  7. FDA approval (target)Target 2027Not yet reached.

Most important updates

Upcoming

  1. Q4 2026BLA submission completion (planned) (next)
  2. 2027FDA approval (target)
  3. Q2 2027KYSA-6 Phase 3 enrollment completion in generalized myasthenia gravis
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