Kyverna Therapeutics said on November 12 that it has completed the submission of its rolling Biologics License Application to the FDA for miv-cel (mivocabtagene autoleucel, KYV-101), its fully human autologous CD19 targeting CAR T cell therapy, in stiff person syndrome, and has requested priority review under the therapy’s Regenerative Medicine Advanced Therapy designation. If approved, miv-cel would be the first approved therapy for stiff person syndrome and the first CAR T therapy approved in autoimmune disease. Kyverna is already running launch readiness work with CAR T treatment sites, neurologists and payers ahead of a potential United States launch in 2027.
The filing rests on the KYSA-8 registrational trial. One year data reported at MS Toronto in October 2026 showed miv-cel reversed disability and met its primary and secondary endpoints, with nearly all patients remaining off chronic immunotherapies after a single dose, and the primary analysis has been published in JAMA Neurology. The company is explicit about what has not happened yet: the FDA may decline to accept the BLA for filing or to grant priority review, and no review clock or target date exists until it does.
The same release reported third quarter finances. Kyverna held 170.6 million dollars in cash, cash equivalents and marketable securities at September 30, 2026, which it says funds operations into 2028, and posted a third quarter net loss of 41.9 million dollars, or 0.68 dollars per share. Behind the lead filing, enrolment in KYSA-6, the Phase 3 trial of miv-cel in generalised myasthenia gravis, remains on track to complete in mid 2027, miv-cel holds three RMAT designations spanning stiff person syndrome, myasthenia gravis and non active secondary progressive multiple sclerosis, and the company has deprioritised its KYV-102 programme to concentrate on the late stage neurology indications.