Calliditas Receives FDA Fast Track Designation for setanaxib in PBC
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for its lead NOX inhibitor candidate setanaxib for the treatment of patients with the chronic orphan liver disease primary biliary cholangitis (PBC). Setanaxib has previously been granted orphan drug designation for PBC in the US and Europe.The FDA Fast Track program facilitates the expedited development and review of new drugs intended to treat serious or life-threatening conditions and that demonstrate