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July 16, 2024

US FDA grants RMAT designation for Kyverna’s KYV-101

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Kyverna Therapeutics’ chimeric antigen receptor (CAR) T-cell product candidate, KYV-101 for treating refractory stiff-person syndrome (SPS).

Till date, approximately 50 patients have been treated with KYV-101's CAR technology. Credit: Steve Buissinne from Pixabay.