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Kyverna Therapeutics Announces Completion of BLA Submission for Miv-cel in Stiff Person Syndrome and Reports Third Quarter 2026 Financial Results

KYTX
  • Kyverna Therapeutics completed submission of a rolling Biologics License Application (BLA) for miv-cel in stiff person syndrome (SPS) and requested priority review from the FDA.
  • The BLA is supported by positive data from the KYSA-8 registrational trial, where one-year results showed durable efficacy and reversal of disability.
  • miv-cel is positioned as the potential first approved CAR-T therapy for an autoimmune disease, with commercial readiness activities advancing for a possible 2027 U.S. launch.
  • The KYSA-6 Phase 3 trial for generalized myasthenia gravis (gMG) remains on-track for enrollment completion in mid-2027.
  • Clinical data across neurologic autoimmune indications demonstrates a consistent safety profile with no high-grade cytokine release syndrome, neurotoxicity, or IEC-HS cases.
  • Kyverna deprioritized the KYV-102 program to focus resources on accelerating late-stage neurologic indications with miv-cel.
  • Financial results for the third quarter ended September 30, 2026, reported $170.6 million in cash & equivalents, a net loss of $41.9 million, and an operating runway expected through 2028.
  • Research and development expenses were $27.0 million, while general and administrative expenses totaled $15.9 million for the quarter.
  • miv-cel has received FDA RMAT designation for SPS, gMG, and non-active secondary progressive multiple sclerosis (naSPMS).
  • Updated Phase 1 data for progressive multiple sclerosis (PMS) showed improved disability scores and durable results beyond two years in the first patient treated.
Company
Kyverna Therapeutics, Inc.
Keywords
Nasdaq:KYTX, Kyverna Therapeutics, Inc.