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

August 11, 2026: Kyverna Therapeutics (NASDAQ: KYTX) said the FDA granted RMAT designation to miv-cel (mivocabtagene autoleucel, KYV-101) for non-active secondary progressive multiple sclerosis (naSPMS), based on clinical data from investigator-initiated trials at Stanford and UCSF in progressive MS. The company expects additional Stanford Phase 1 IIT data in Q4 2026 and a PMS development strategy update by early 2027.

For stiff person syndrome (SPS), Kyverna said its rolling BLA for miv-cel is underway, with the CMC module submitted and full submission on track for Q4 2026. The company plans to seek priority review under RMAT, with potential commercial launch in 2027 if approved. Twelve-month topline data from the KYSA-8 study are expected in Q3 2026.

For generalized myasthenia gravis (gMG), Kyverna said enrollment is ongoing in the Phase 3 KYSA-6 registrational trial, with enrollment completion expected by mid-2027. Longer-term follow-up Phase 2 topline data are expected in Q3 2026.

Kyverna reported $199.4 million in cash, cash equivalents, and marketable securities as of June 30, 2026, and said its operating runway extends into 2028.