Kyverna Completes Miv-cel Stiff Person Syndrome BLA

The Tip Desk · November 12, 2026 · 3 min read

The company reported a $41.9 million net loss, or $0.68 a share, for the third quarter ended September 30, 2026.

Kyverna Therapeutics, Inc. (KYTX), a late-stage clinical immunology company developing CAR T-cell therapies for neurologic autoimmune diseases, completed its rolling Biologics License Application for miv-cel in stiff person syndrome and asked the FDA for priority review.

The submission, made under the company’s Regenerative Medicine Advanced Therapy designation, was based on the KYSA-8 registrational trial. In the prior quarter Kyverna had said it was on track to finish the rolling BLA in the fourth quarter of 2026.

Chief Executive Officer Warner Biddle said the company is advancing commercial readiness for a potential U.S. launch of miv-cel, which would become the first approved therapy for SPS and the first approved CAR-T therapy in autoimmune disease. The company said it is hiring commercial leaders with expertise in CAR T, neurology and rare-disease launches, starting field infrastructure, and working with treatment centers on patient access. It is also recruiting field-based sales and medical specialists.

One-year SPS data presented at MS Toronto in October 2026 showed miv-cel reversed disability and achieved durable efficacy across primary and secondary endpoints, with nearly all patients remaining off chronic immunotherapies after a single dose. The company said the therapy continued to show a consistent safety profile, with no high-grade cytokine release syndrome, ICANS, or IEC-HS. Primary KYSA-8 results were published in JAMA Neurology.

Enrollment in the KYSA-6 Phase 3 trial for generalized myasthenia gravis remains on track for completion in mid-2027. Longer-term Phase 2 follow-up presented in September 2026 showed a durable effect for up to 1.5 years, with the majority of patients maintaining minimal symptom expression and staying off chronic immunotherapies.

In progressive multiple sclerosis, updated Stanford Phase 1 investigator-initiated data presented at MS Toronto supported improved disability scores and central nervous system CAR T penetration without chronic immunotherapies, with durable results beyond two years in the first patient treated. RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis had been granted earlier in the year. Kyverna expects to share its PMS development strategy by early 2027.

The company elected to deprioritize its KYV-102 program to focus on late-stage miv-cel neurologic indications. It said it will continue lifecycle-management activities for miv-cel to broaden access and lower costs.

Research and development expenses were $27.0 million for the third quarter ended September 30, 2026, down from $30.5 million a year earlier. General and administrative expenses were $15.9 million, up from $8.3 million. The company reported a net loss of $41.9 million, or $0.68 a share, versus a $36.8 million loss, or $0.85 a share, in the year-ago quarter. Weighted-average shares outstanding were 61.96 million.

Cash, cash equivalents, and marketable securities were $170.6 million as of September 30, 2026. Kyverna said that amount, in addition to availability under its Oxford Finance amended loan facility, is expected to provide operating runway into 2028. Loan payable, net, was $25.0 million.

The company said it is rapidly progressing launch-readiness activities through site activation with CAR-T experts, neurologists and payers, and building a patient support and reimbursement network, in anticipation of a potential FDA approval and commercial launch in 2027.