Kyverna Therapeutics releases one‑year data from miv‑cel trial in stiff person syndrome
Kyverna Therapeutics presented one‑year results from its KYSA‑8 registrational trial of the CAR‑T therapy miv‑cel in 26 patients with stiff person syndrome. The data showed durable efficacy, with most patients improving walking speed and remaining off chronic immunosuppressive drugs. Safety remained favorable, with no high‑grade cytokine release syndrome or neurotoxicity reported. The company said the results strengthen its biologics license application for the first approved therapy in this disease.
Why it matters
The company indicated the data bolster its BLA package and could accelerate FDA review, which may move the stock higher if approval is granted. Investors should watch for any regulatory updates following the data release.
Key facts
- 1Twenty of 26 patients (77%) achieved a clinically meaningful ≥20% improvement in the timed 25‑foot walk at one year. stocktitan.net
- 2Eight of 12 patients (67%) who required walking aids before treatment no longer needed assistance at one year. investing.com
- 3Twenty‑four of 26 patients (92%) remained free of chronic immunotherapies for SPS at one year. stocktitan.net
- 4No high‑grade cytokine release syndrome or immune effector cell‑associated neurotoxicity syndrome occurred during the one‑year follow‑up. investing.com
- 5The one‑year data were presented on October 21, 2026 at the MS Toronto 2026 meeting. stocktitan.net
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.