Pleased to share we have received U.S. FDA RMAT Designation for #KYV101 in the treatment of patients with refractory Stiff-Person Syndrome. 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. #stiffpersonsyndrome #cartcelltherapy https://lnkd.in/gvX7uqBy
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1moCongrats from GordonMD® Global Investments LP A nice step for patients with a big unmet medical need!