Kyverna Therapeutics Inc. (KYTX) announced that its autologous, fully human CD19 chimeric antigen receptor or CAR T-cell product candidate, KYV-101, has been designated as a Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration for treating patients with refractory stiff-person syndrome.
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.
KYV-101 is currently being evaluated in sponsored, open-label, Phase 1/2 and Phase 2 trials of KYV-101 in the United States and Germany across two broad areas of autoimmune disease: rheumatology and neurology.
KYV-101 is also being evaluated in investigator-initiated trials for multiple indications in multiple geographies.
KYTX closed Monday's regular trading at $9.91 up $0.12 or 1.23%. In the after-hours trading, the stock further gained $0.74 or 7.47%.
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May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.