hapabapa Kyverna Therapeutics ( NASDAQ: KYTX ) traded higher on Monday after the U.S. FDA greenlighted a mid-stage clinical trial for its lead candidate, KYV-101, in patients with a rare disease called stiff-person syndrome (SPS).
The FDA nod for its Investigational New Drug (IND) application paves the way for Kyverna ( KYTX ) to test the autologous CD19-targeting CAR T-cell therapy in KYSA-8, a Phase 2 open-label clinical trial. SPS is a neurological autoimmune disorder characterized by muscle stiffness that restricts the ability to walk or move. "The IND clearance gives us confidence in our dedication to bringing a potential paradigm shift in the treatment of patients suffering from SPS and reaffirms a target dose of 100 million cells for KYV-101," said Sham Dholakia, head of Kyverna's ( KYTX ) rare diseases unit.
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