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Kyverna Plans to Seek FDA Approval for Its CAR-T Therapy (Stiff Person Syndrome)

2026-04-21

Source:STAT News

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According to research results released on Tuesday, a one-time, personalized cell therapy developed by Kyverna Therapeutics has improved mobility and reduced disability levels in patients suffering from Stiff Person Syndrome—a rare neurological autoimmune disorder.


Kyverna plans to submit an application for this therapy to the U.S. Food and Drug Administration (FDA) by mid-year. If approved, it would become the first therapy specifically for the treatment of Stiff Person Syndrome, as well as the first personalized CAR-T therapy to reach the market for a range of autoimmune diseases.


According to research results released on Tuesday, a one-time, personalized cell therapy developed by Kyverna Therapeutics has improved mobility and reduced disability levels in patients suffering from Stiff Person Syndrome—a rare neurological autoimmune disorder.


Kyverna plans to submit an application for this therapy to the U.S. Food and Drug Administration (FDA) by mid-year. If approved, it would become the first therapy specifically for the treatment of Stiff Person Syndrome, as well as the first personalized CAR-T therapy to reach the market for a range of autoimmune diseases.

 

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