Kyverna completes BLA submission for miv-cel in stiff person syndrome
Posted on November 15, 2026
Kyverna Therapeutics has completed its rolling Biologics License Application submission to the U.S. Food and Drug Administration for miv-cel in stiff person syndrome.
The company is seeking Priority Review for the therapy, also known as mivocabtagene autoleucel or KYV-101, under its Regenerative Medicine Advanced Therapy designation.
The application is supported by data from the registrational KYSA-8 study in patients with stiff person syndrome.
Kyverna said it is also advancing commercial preparations ahead of a potential U.S. launch in 2027 if the treatment receives FDA approval.
The company is working with CAR-T treatment centres, neurologists and payers while building patient support and reimbursement infrastructure.
One-year data from KYSA-8 reported in October 2026 showed durable improvements across the study’s primary and secondary endpoints.
Kyverna said nearly all patients remained off chronic immunotherapies following a single dose of miv-cel.
The treatment has also continued to demonstrate a consistent safety profile.
No high-grade cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome was reported in the SPS programme.
There were also no reported cases of immune effector cell-associated haemophagocytic lymphohistiocytosis-like syndrome.
Primary KYSA-8 results have been published in JAMA Neurology, while additional one-year biomarker findings are expected to be presented at the 2026 American Society of Hematology Annual Meeting.
Miv-cel is a fully human autologous CD19-directed CAR-T therapy incorporating CD28 co-stimulation.
The therapy is designed to achieve deep B-cell depletion with the aim of resetting the immune system and producing durable clinical benefit following a single administration.
Kyverna is also evaluating miv-cel across other neurological autoimmune conditions.
The Phase III KYSA-6 study in generalised myasthenia gravis remains on track to complete enrolment in mid-2027.
Longer-term Phase II follow-up has shown clinical responses lasting up to 18 months, with many patients maintaining minimal symptom expression and remaining off chronic immunotherapies.
Miv-cel is also being investigated in progressive multiple sclerosis.
Updated Phase I investigator-initiated data from Stanford University showed improvements in disability measures alongside evidence of CAR-T penetration into the central nervous system.
The first patient treated has maintained a response beyond two years, according to Kyverna.
The FDA has granted RMAT designation to miv-cel for non-active secondary progressive multiple sclerosis, and Kyverna expects to provide an update on its development strategy in early 2027.
The company has meanwhile decided to deprioritise its KYV-102 programme as it focuses resources on late-stage development of miv-cel.
As of September 30, 2026, Kyverna reported $170.6 million in cash, cash equivalents and marketable securities.
The company expects its available resources, together with access to its Oxford Finance loan facility, to support operations into 2028.
Kyverna reported third-quarter research and development expenses of $27.0 million and general and administrative expenses of $15.9 million.
Net loss for the quarter was $41.9 million, or $0.68 per common share.
Related Topics and Keywords
autoimmune disease, B-cell depletion, Biologics License Application, Biopharma, bla, CAR-T, CD19, cell therapy, clinical trials, FDA, generalised myasthenia gravis, KYSA-6, KYSA-8, KYV-101, Kyverna Therapeutics, miv-cel, mivocabtagene autoleucel, neuroimmunology, pharma news, priority review, progressive multiple sclerosis, RMAT, SPS, stiff person syndrome
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