Kyverna Therapeutics used the Morgan Stanley 24th Annual Global Healthcare Conference on Sept. 14, 2026, to announce the first autoimmune CAR‑T therapy to enter pivotal trials. The company’s lead program, miv‑cel, targets stiff‑person syndrome (SPS) and generalized myasthenia gravis (gMG) and is supported by a rolling Biologics License Application expected to be completed in Q4 2024, with the chemistry, manufacturing and controls (CMC) module already filed in Q2 2024.
In the SPS pivotal KYSA‑8 trial, safety data showed no high‑grade cytokine release syndrome or immune effector cell‑associated neurotoxicity syndrome across more than 100 treated patients. Manufacturing yield reached 98%, and the primary endpoint – a timed 25‑foot walk – improved by 46%. More than two‑thirds of the 12 patients who required walking aids no longer needed them by trial end.
For gMG, the Phase 2 KYSA‑6 study enrolled seven patients, all of whom met the 24‑week primary endpoint, with five remaining on therapy beyond one year. Scores on the Myasthenia Gravis Activities of Daily Living (MG‑ADL) scale fell 8.5 points and Quantitative Myasthenia Gravis (QMG) scores dropped 11.3 points.
Physician surveys indicated 90% strong support for the therapeutic profile and 85% willingness to use miv‑cel in moderate to severe cases. The company positioned its pricing above the current $500,000‑$600,000 CAR‑T range, arguing that conventional IVIG treatment for SPS can cost hundreds of thousands of dollars annually, excluding caregiver and productivity losses.
Kyverna’s stock closed at $7.40, up 1.93% from $7.26, after a week‑long decline of 12% and a year‑to‑date drop of 23%. Despite the recent dip, the stock has posted an 85% gain over the past year.
CEO Warner Biddle emphasized the clinical breakthrough, stating, “For the first time ever, not only seeing clinical improvements in these patients, but for the first time ever, actually seeing a reversal of disease and a reversal of disability.” He added confidence in the manufacturing process and safety profile, and affirmed a “definitely” expectation for priority review from the FDA.
Kyverna noted that further development plans for progressive multiple sclerosis will be outlined in 2027 after additional FDA discussions.
