Miv-cel (mivocabtagene autoleucel, KYV-101) - (KYSA-8)

Jan. 12, 2026: Kyverna Therapeutics, Inc. (NASDAQ: KYTX) provided a 2026 corporate update highlighting upcoming regulatory and clinical catalysts for miv-cel (mivocabtagene autoleucel, KYV-101), its autologous CD19 CAR T therapy for autoimmune disease.

• Stiff person syndrome (SPS): Following positive topline data from the KYSA-8 registrational trial, Kyverna plans to submit a Biologics License Application (BLA) to the FDA in 1H 2026 and report full registrational data in 1H 2026. The company also targets SPS launch readiness by year-end 2026.
• Generalized myasthenia gravis (gMG): The first patient was enrolled in December 2025 in the Phase 3 portion of the FDA-aligned KYSA-6 registrational trial; updated Phase 2 data from the gMG trial are expected in 2026.
• KYV-102 (whole blood rapid manufacturing process): The IND was accepted by the U.S. FDA in January 2026 after filing in December 2025.

Other updates: In December 2025, Kyverna raised ~$105M gross in a follow-on offering; preliminary cash/marketable securities were ~$279M as of Dec. 31, 2025, extending runway into 2028. Kyverna also announced Christi Shaw’s appointment as Executive Chairperson.