FDA Clears KT501 for U.S. Autoimmune Study

Company: Kali Therapeutics · Asset: KT501 (CD19xBCMAxCD3 Masked Trispecific) · Indication: B-Cell-Mediated Autoimmune Disease · Regulatory Action: U.S. IND Cleared · Date: September 3, 2026 Summary Kali Therapeutics disclosed FDA clearance of KT501, a masked CD19xBCMAxCD3 trispecific T-cell engager, enabling U.S. development for B-cell-mediated autoimmune…

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