BioStock: Saniona on the positive feedback from FDA

Report this content

Last week, Saniona announced that the FDA had granted Orphan Drug Designation (ODD) for the drug candidate Tesomet for the treatment of Prader-Willi syndrome (PWS). A few days later, a different Division at the FDA returned with positive feedback on the regulatory path forward in the rare disease of hypothalamic obesity. Saniona now looks set to follow its planned timeline and start phase IIb studies in both PWS and HO before the summer. BioStock reached out to Rudolf Baumgartner, M.D., Chief Medical Officer and Head of Clinical Development at Saniona, for a comment.

Read the full interview with Rudolf Baumgartner at

This is a press release from BioStock - Connecting Innovation & Capital.


Quick facts

BioStock: Saniona on the positive feedback from FDA
Tweet this


As part of our process of submitting for Orphan Drug Designatiuons, we have recently conducted new analyses to verify the size of the PWS and HO patient populations. We do believe both of these indications, while clearly rare diseases, may impact more people than we initially suspected
Rudolf Baumgartner, CMO and Head of Clinical Development, Saniona