Pilatus Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its leading molecule, PLT012, for treating liver and intrahepatic bile duct cancer (HCC/ICCA). Achieved in November 2024, this designation marks a crucial advancement in developing innovative therapies for patients facing these challenging cancers. Dr. Raven Lin, CEO, emphasized the company’s commitment to addressing urgent medical needs, while Prof. Ping-Chih Ho highlighted PLT012’s unique therapeutic approach targeting the tumor microenvironment. Pilatus is actively working with regulatory authorities to expedite PLT012’s development and availability.
