Kyverna Gets FDA Regenerative Medicine Status

FDA has granted Kyverna Therapeutics a regenerative medicine advanced therapy designation for the company’s autologous CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, and its use to treat patients suffering from progressive myasthenia gravis. The autoimmune disorder is associated with muscle weakness in tissues throughout the body, potentially manifesting in partial paralysis of eye movements, problems in chewing and swallowing, respiratory problems, speech difficulties and weakness in skeletal muscles, according to the company. “With 50 patients treated so far with the CAR in KYV-101 in both oncological and autoimmune conditions at more than 15 locations in Europe and the U.S., we believe that the differentiated properties of KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies,” the company says.