Kyverna receives advanced therapy designation for KYV-101
Drug Discovery World
JULY 17, 2024
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kyverna Therapeutic’s CAR-T candidate KYV-101 for refractory stiff-person syndrome (SPS). KYV-101 is an autologous, fully human CD19 CAR-T cell product candidate for use in B cell-driven autoimmune diseases. The RMAT designation was based on positive clinical outcomes in patients treated in Germany under a named-patient treatment option.
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