CS0159 Receives FDA Orphan Drug Designation for PBC Indication

Following its prior receipt of FDA Breakthrough Therapy Designation (BTD) for the treatment of Primary Biliary Cholangitis (PBC), the self-developed Class 1 new drug CS0159 oral tablet from Cascade has now also received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the same PBC indication.

This dual recognition of both BTD and ODD marks a significant breakthrough in the development of CS0159 for the treatment of PBC, laying a solid foundation for its subsequent clinical development and market promotion.