FDA Grants Regenerative Medicine Advanced Therapy Designation to Kyverna's KYV-101 for Refractory Stiff-Person Syndrome

According to a recent announcement, the FDA has granted regenerative medicine advanced therapy (RMAT) designation to Kyverna Therapeutics’ KYV-101, an investigational CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with refractory stiff-person syndrome (SPS).