Kyverna Gets FDA RMAT Designation For KYV-101 In Refractory Stiff-Person Syndrome Treatment;stock Up

(RTTNews) - 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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