HepaRegeniX Receives Orphan Drug Designation for Darizmetinib for the Prevention of Post-Hepatectomy Liver Failure
U.S. FDA Orphan Drug Designation underscores darizmetinib’s potential to address a significant unmet need following liver resection Tuebingen, Germany, August 26, 2026 – HepaRegeniX GmbH (“HepaRegeniX”), a clinical-stage biotech company advancing novel therapies for acute and chronic liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to darizmetinib (formerly HRX215) for the