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The application was evaluated based on the positive clinical outcomes of KYV-101 in patients treated in Germany under a named-patient treatment option
The Regenerative Medicine Advanced Therapies designation will allow Kyverna to receive expert guidance on efficient drug development and use of surrogate endpoints from senior FDA officials
EMERYVILLE, Calif., July 15, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, announced today the designation as Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of patients suffering from refractory stiff-person syndrome.
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