BioStock: Saniona's CMO on the FDA Orphan Drug Designation for Tesomet in HO
Last week, Saniona announced that the U.S. Food and Drug Administration has granted orphan drug designation to Tesomet for the treatment of hypothalamic obesity (HO), making Saniona the first company to achieve this milestone. BioStock reached out to Rudolf Baumgartner, MD, Chief Medical Officer and Head of Clinical Development at Saniona, to learn more about the significance of the FDA’s decision, as well as the plans to initiate phase IIb studies in the second half of 2021 for both HO and Prader-Willi syndrome (PWS) – an indication the company obtained orphan drug status for from the FDA